Clinical Edge Journal Scan

Key clinical point: Nanoparticle albumin‐bound (nab) paclitaxel showed promising clinical activity and tolerable safety in patients with metastatic breast cancer (BC) who were previously treated with taxanes, regardless of their sensitivity or resistance to taxane therapy.

Major finding: The median progression-free survival (PFS) was 7.20 months (95% CI 6.63-7.80 months) for all patients. The median PFS was significantly longer (7.57 vs 4.43 months; P < .001) and the disease control rate was 88.24% vs 68.00% in patients who were taxane-sensitive vs taxane-resistant. Neutropenia (21.19%), leukopenia (19.49%), and sensory neuropathy (6.36%) were the most frequent grade 3-4 adverse events.

Study details: Findings are from a retrospective study including 236 taxane-pretreated women with metastatic BC, of whom 184 were sensitive and 52 were resistant to taxanes based on previous treatment and received nab-paclitaxel as monotherapy or combination therapy.

Disclosures: This study was supported by the Jiangsu Provincial Medical Youth Talent and the Talents Program of Jiangsu Cancer Hospital, China. The authors declared no conflicts of interest.

Source: Xiong W, Xu T, Liu X, Zhang L, Yuan Y. Efficacy and safety of nanoparticle albumin-bound paclitaxel in taxane-pretreated metastatic breast cancer patients. Cancer. 2024 (Jan 25). doi: 10.1002/cncr.35206 Source

Key clinical point: Nanoparticle albumin‐bound (nab) paclitaxel showed promising clinical activity and tolerable safety in patients with metastatic breast cancer (BC) who were previously treated with taxanes, regardless of their sensitivity or resistance to taxane therapy.

Major finding: The median progression-free survival (PFS) was 7.20 months (95% CI 6.63-7.80 months) for all patients. The median PFS was significantly longer (7.57 vs 4.43 months; P < .001) and the disease control rate was 88.24% vs 68.00% in patients who were taxane-sensitive vs taxane-resistant. Neutropenia (21.19%), leukopenia (19.49%), and sensory neuropathy (6.36%) were the most frequent grade 3-4 adverse events.

Study details: Findings are from a retrospective study including 236 taxane-pretreated women with metastatic BC, of whom 184 were sensitive and 52 were resistant to taxanes based on previous treatment and received nab-paclitaxel as monotherapy or combination therapy.

Disclosures: This study was supported by the Jiangsu Provincial Medical Youth Talent and the Talents Program of Jiangsu Cancer Hospital, China. The authors declared no conflicts of interest.

Source: Xiong W, Xu T, Liu X, Zhang L, Yuan Y. Efficacy and safety of nanoparticle albumin-bound paclitaxel in taxane-pretreated metastatic breast cancer patients. Cancer. 2024 (Jan 25). doi: 10.1002/cncr.35206 Source

Key clinical point: Nanoparticle albumin‐bound (nab) paclitaxel showed promising clinical activity and tolerable safety in patients with metastatic breast cancer (BC) who were previously treated with taxanes, regardless of their sensitivity or resistance to taxane therapy.

Major finding: The median progression-free survival (PFS) was 7.20 months (95% CI 6.63-7.80 months) for all patients. The median PFS was significantly longer (7.57 vs 4.43 months; P < .001) and the disease control rate was 88.24% vs 68.00% in patients who were taxane-sensitive vs taxane-resistant. Neutropenia (21.19%), leukopenia (19.49%), and sensory neuropathy (6.36%) were the most frequent grade 3-4 adverse events.

Study details: Findings are from a retrospective study including 236 taxane-pretreated women with metastatic BC, of whom 184 were sensitive and 52 were resistant to taxanes based on previous treatment and received nab-paclitaxel as monotherapy or combination therapy.

Disclosures: This study was supported by the Jiangsu Provincial Medical Youth Talent and the Talents Program of Jiangsu Cancer Hospital, China. The authors declared no conflicts of interest.

Source: Xiong W, Xu T, Liu X, Zhang L, Yuan Y. Efficacy and safety of nanoparticle albumin-bound paclitaxel in taxane-pretreated metastatic breast cancer patients. Cancer. 2024 (Jan 25). doi: 10.1002/cncr.35206 Source

Key clinical point: Poziotinib demonstrated promising antitumor activity but high toxicity in patients with human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer (BC) who were heavily pretreated with HER2-directed therapy.

Major finding: Intermittent and continuous dosing schedules of poziotinib led to objective response rates of 30% each (P = .98) and disease control rates of 60% and 78% (P = .15), respectively. Grades 3-4 treatment-related adverse events were reported by 67% and 76% of patients receiving intermittent and continuous dosing schedules of poziotinib, respectively.

Study details: This phase 2 trial included 67 patients with HER2+ advanced BC who were previously treated with two or more HER2-directed regimens and who received 24 mg poziotinib once daily on an intermittent dosing schedule (n = 33) or 16 mg poziotinib once daily on a continuous dosing schedule (n = 34).

Disclosures: This study received financial support from Spectrum Pharmaceuticals. Gajanan Bhat and Szu-Yun Leu declared being employees of Spectrum Pharmaceuticals. Adam Brufsky declared serving as a consultant for and receiving research support from various sources. The other authors did not declare any conflicts of interest.

Source: Nasrazadani A, Marti JLG, Lathrop K, et al. Poziotinib treatment in patients with HER2-positive advanced breast cancer who have received prior anti-HER2 regimens. Breast Cancer Res Treat. 2024 (Jan 23). doi: 10.1007/s10549-023-07236-z  Source

Key clinical point: Poziotinib demonstrated promising antitumor activity but high toxicity in patients with human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer (BC) who were heavily pretreated with HER2-directed therapy.

Major finding: Intermittent and continuous dosing schedules of poziotinib led to objective response rates of 30% each (P = .98) and disease control rates of 60% and 78% (P = .15), respectively. Grades 3-4 treatment-related adverse events were reported by 67% and 76% of patients receiving intermittent and continuous dosing schedules of poziotinib, respectively.

Study details: This phase 2 trial included 67 patients with HER2+ advanced BC who were previously treated with two or more HER2-directed regimens and who received 24 mg poziotinib once daily on an intermittent dosing schedule (n = 33) or 16 mg poziotinib once daily on a continuous dosing schedule (n = 34).

Disclosures: This study received financial support from Spectrum Pharmaceuticals. Gajanan Bhat and Szu-Yun Leu declared being employees of Spectrum Pharmaceuticals. Adam Brufsky declared serving as a consultant for and receiving research support from various sources. The other authors did not declare any conflicts of interest.

Source: Nasrazadani A, Marti JLG, Lathrop K, et al. Poziotinib treatment in patients with HER2-positive advanced breast cancer who have received prior anti-HER2 regimens. Breast Cancer Res Treat. 2024 (Jan 23). doi: 10.1007/s10549-023-07236-z  Source

Key clinical point: Poziotinib demonstrated promising antitumor activity but high toxicity in patients with human epidermal growth factor receptor 2-positive (HER2+) advanced breast cancer (BC) who were heavily pretreated with HER2-directed therapy.

Major finding: Intermittent and continuous dosing schedules of poziotinib led to objective response rates of 30% each (P = .98) and disease control rates of 60% and 78% (P = .15), respectively. Grades 3-4 treatment-related adverse events were reported by 67% and 76% of patients receiving intermittent and continuous dosing schedules of poziotinib, respectively.

Study details: This phase 2 trial included 67 patients with HER2+ advanced BC who were previously treated with two or more HER2-directed regimens and who received 24 mg poziotinib once daily on an intermittent dosing schedule (n = 33) or 16 mg poziotinib once daily on a continuous dosing schedule (n = 34).

Disclosures: This study received financial support from Spectrum Pharmaceuticals. Gajanan Bhat and Szu-Yun Leu declared being employees of Spectrum Pharmaceuticals. Adam Brufsky declared serving as a consultant for and receiving research support from various sources. The other authors did not declare any conflicts of interest.

Source: Nasrazadani A, Marti JLG, Lathrop K, et al. Poziotinib treatment in patients with HER2-positive advanced breast cancer who have received prior anti-HER2 regimens. Breast Cancer Res Treat. 2024 (Jan 23). doi: 10.1007/s10549-023-07236-z  Source

Key clinical point: Both hypofractionated (HF) and conventional fractionated (CF) radiotherapy were comparably effective in patients who had undergone surgery for breast cancer (BC); however, the HF vs CF regimen was more effective in reducing skin toxicity and relieving fatigue.

Major finding: CF vs HF radiotherapy demonstrated no significant improvement in terms of local recurrence (odds ratio [OR] 0.91; P  =  .30) or overall survival (OR 1.08; P  =  .28) outcomes. Although safety outcomes like breast pain, breast atrophy, lymphedema, pneumonia, pulmonary fibrosis, telangiectasia, and cardiotoxicity were comparable in both groups, HF vs CF regimen led to lower skin toxicity (OR 0.43; P < .01) and improved patient fatigue outcomes (OR 0.73; P < .01).

Study details: This meta-analysis of 35 studies included 18,246 patients diagnosed with BC who underwent surgery and were treated with HF or CF radiotherapy.

Disclosures: This study was supported by the Key Research and Development Projects of Shaanxi Province, China, and other sources. The authors declared no conflicts of interest.

Source: Lu Y, Hui B, Yang D, et al. Efficacy and safety analysis of hypofractionated and conventional fractionated radiotherapy in postoperative breast cancer patients. BMC Cancer. 2024;24:181. doi: 10.1186/s12885-024-11918-2  Source

Key clinical point: Both hypofractionated (HF) and conventional fractionated (CF) radiotherapy were comparably effective in patients who had undergone surgery for breast cancer (BC); however, the HF vs CF regimen was more effective in reducing skin toxicity and relieving fatigue.

Major finding: CF vs HF radiotherapy demonstrated no significant improvement in terms of local recurrence (odds ratio [OR] 0.91; P  =  .30) or overall survival (OR 1.08; P  =  .28) outcomes. Although safety outcomes like breast pain, breast atrophy, lymphedema, pneumonia, pulmonary fibrosis, telangiectasia, and cardiotoxicity were comparable in both groups, HF vs CF regimen led to lower skin toxicity (OR 0.43; P < .01) and improved patient fatigue outcomes (OR 0.73; P < .01).

Study details: This meta-analysis of 35 studies included 18,246 patients diagnosed with BC who underwent surgery and were treated with HF or CF radiotherapy.

Disclosures: This study was supported by the Key Research and Development Projects of Shaanxi Province, China, and other sources. The authors declared no conflicts of interest.

Source: Lu Y, Hui B, Yang D, et al. Efficacy and safety analysis of hypofractionated and conventional fractionated radiotherapy in postoperative breast cancer patients. BMC Cancer. 2024;24:181. doi: 10.1186/s12885-024-11918-2  Source

Key clinical point: Both hypofractionated (HF) and conventional fractionated (CF) radiotherapy were comparably effective in patients who had undergone surgery for breast cancer (BC); however, the HF vs CF regimen was more effective in reducing skin toxicity and relieving fatigue.

Major finding: CF vs HF radiotherapy demonstrated no significant improvement in terms of local recurrence (odds ratio [OR] 0.91; P  =  .30) or overall survival (OR 1.08; P  =  .28) outcomes. Although safety outcomes like breast pain, breast atrophy, lymphedema, pneumonia, pulmonary fibrosis, telangiectasia, and cardiotoxicity were comparable in both groups, HF vs CF regimen led to lower skin toxicity (OR 0.43; P < .01) and improved patient fatigue outcomes (OR 0.73; P < .01).

Study details: This meta-analysis of 35 studies included 18,246 patients diagnosed with BC who underwent surgery and were treated with HF or CF radiotherapy.

Disclosures: This study was supported by the Key Research and Development Projects of Shaanxi Province, China, and other sources. The authors declared no conflicts of interest.

Source: Lu Y, Hui B, Yang D, et al. Efficacy and safety analysis of hypofractionated and conventional fractionated radiotherapy in postoperative breast cancer patients. BMC Cancer. 2024;24:181. doi: 10.1186/s12885-024-11918-2  Source

Key clinical point: Compared with patients having metaplastic breast cancer (MpBC) who did not receive any chemotherapy, prognostic outcomes were significantly improved in those who received neoadjuvant chemotherapy (NAC) or adjuvant chemotherapy.

Major finding: Compared with patients who did not receive any chemotherapy, the overall survival (OS) improved significantly in those who received adjuvant chemotherapy (hazard ratio [HR] 0.451; P < .001) or responded to NAC (HR 0.479; P < .001). Breast cancer-specific survival also improved in patients who received and responded to NAC or received adjuvant chemotherapy.

Study details: This study analyzed data from the Surveillance, Epidemiology, and End Results (SEER) database and included 1186 patients with MpBC who received NAC (n = 181), adjuvant chemotherapy (n = 647), or did not receive any chemotherapy (n = 358).

Disclosures: This study was supported by the Science and Technology Innovation Plan of Shanghai Science and Technology Commission and the Obstetrics and Gynecology Hospital of Fudan University. The authors declared no conflicts of interest.

Source: Zhang M, Yuan J, Wang M, Zhang M, Chen H. Chemotherapy is of prognostic significance to metaplastic breast cancer. Sci Rep. 2024;14:1210. doi: 10.1038/s41598-024-51627-1 Source

Key clinical point: Compared with patients having metaplastic breast cancer (MpBC) who did not receive any chemotherapy, prognostic outcomes were significantly improved in those who received neoadjuvant chemotherapy (NAC) or adjuvant chemotherapy.

Major finding: Compared with patients who did not receive any chemotherapy, the overall survival (OS) improved significantly in those who received adjuvant chemotherapy (hazard ratio [HR] 0.451; P < .001) or responded to NAC (HR 0.479; P < .001). Breast cancer-specific survival also improved in patients who received and responded to NAC or received adjuvant chemotherapy.

Study details: This study analyzed data from the Surveillance, Epidemiology, and End Results (SEER) database and included 1186 patients with MpBC who received NAC (n = 181), adjuvant chemotherapy (n = 647), or did not receive any chemotherapy (n = 358).

Disclosures: This study was supported by the Science and Technology Innovation Plan of Shanghai Science and Technology Commission and the Obstetrics and Gynecology Hospital of Fudan University. The authors declared no conflicts of interest.

Source: Zhang M, Yuan J, Wang M, Zhang M, Chen H. Chemotherapy is of prognostic significance to metaplastic breast cancer. Sci Rep. 2024;14:1210. doi: 10.1038/s41598-024-51627-1 Source

Key clinical point: Compared with patients having metaplastic breast cancer (MpBC) who did not receive any chemotherapy, prognostic outcomes were significantly improved in those who received neoadjuvant chemotherapy (NAC) or adjuvant chemotherapy.

Major finding: Compared with patients who did not receive any chemotherapy, the overall survival (OS) improved significantly in those who received adjuvant chemotherapy (hazard ratio [HR] 0.451; P < .001) or responded to NAC (HR 0.479; P < .001). Breast cancer-specific survival also improved in patients who received and responded to NAC or received adjuvant chemotherapy.

Study details: This study analyzed data from the Surveillance, Epidemiology, and End Results (SEER) database and included 1186 patients with MpBC who received NAC (n = 181), adjuvant chemotherapy (n = 647), or did not receive any chemotherapy (n = 358).

Disclosures: This study was supported by the Science and Technology Innovation Plan of Shanghai Science and Technology Commission and the Obstetrics and Gynecology Hospital of Fudan University. The authors declared no conflicts of interest.

Source: Zhang M, Yuan J, Wang M, Zhang M, Chen H. Chemotherapy is of prognostic significance to metaplastic breast cancer. Sci Rep. 2024;14:1210. doi: 10.1038/s41598-024-51627-1 Source

Key clinical point: Patients with early-stage triple-negative breast cancer (TNBC) should receive adjuvant chemotherapy without unnecessary delays after primary surgery because prognosis may worsen if treatment is postponed beyond 6 weeks.

Major finding: Patients who received adjuvant systemic therapy within 22-28 days after surgery reported the most favorable overall survival (OS) outcomes (median OS 10.2 years), with the OS decreasing in the groups that received adjuvant systemic therapy during 29-35 days, 36-42 days, and >6 weeks after surgery (8.3 years, 7.8 years, and 6.9 years, respectively).

Study details: Findings are from a retrospective cohort study that included 245 patients with early TNBC who received adjuvant chemotherapy after primary surgery.

Disclosures: The open access funding for this study was enabled and organized by Projekt DEAL. Some authors declared receiving honoraria or travel reimbursements from or serving as consultants or board members for various sources.

Source: Hatzipanagiotou ME, Pigerl M, Gerken M, et al. Clinical impact of delaying initiation of adjuvant chemotherapy in patients with early triple negative breast cancer. Breast Cancer Res Treat. 2024 (Jan 19). doi: 10.1007/s10549-023-07207-4 Source

Key clinical point: Patients with early-stage triple-negative breast cancer (TNBC) should receive adjuvant chemotherapy without unnecessary delays after primary surgery because prognosis may worsen if treatment is postponed beyond 6 weeks.

Major finding: Patients who received adjuvant systemic therapy within 22-28 days after surgery reported the most favorable overall survival (OS) outcomes (median OS 10.2 years), with the OS decreasing in the groups that received adjuvant systemic therapy during 29-35 days, 36-42 days, and >6 weeks after surgery (8.3 years, 7.8 years, and 6.9 years, respectively).

Study details: Findings are from a retrospective cohort study that included 245 patients with early TNBC who received adjuvant chemotherapy after primary surgery.

Disclosures: The open access funding for this study was enabled and organized by Projekt DEAL. Some authors declared receiving honoraria or travel reimbursements from or serving as consultants or board members for various sources.

Source: Hatzipanagiotou ME, Pigerl M, Gerken M, et al. Clinical impact of delaying initiation of adjuvant chemotherapy in patients with early triple negative breast cancer. Breast Cancer Res Treat. 2024 (Jan 19). doi: 10.1007/s10549-023-07207-4 Source

Key clinical point: Patients with early-stage triple-negative breast cancer (TNBC) should receive adjuvant chemotherapy without unnecessary delays after primary surgery because prognosis may worsen if treatment is postponed beyond 6 weeks.

Major finding: Patients who received adjuvant systemic therapy within 22-28 days after surgery reported the most favorable overall survival (OS) outcomes (median OS 10.2 years), with the OS decreasing in the groups that received adjuvant systemic therapy during 29-35 days, 36-42 days, and >6 weeks after surgery (8.3 years, 7.8 years, and 6.9 years, respectively).

Study details: Findings are from a retrospective cohort study that included 245 patients with early TNBC who received adjuvant chemotherapy after primary surgery.

Disclosures: The open access funding for this study was enabled and organized by Projekt DEAL. Some authors declared receiving honoraria or travel reimbursements from or serving as consultants or board members for various sources.

Source: Hatzipanagiotou ME, Pigerl M, Gerken M, et al. Clinical impact of delaying initiation of adjuvant chemotherapy in patients with early triple negative breast cancer. Breast Cancer Res Treat. 2024 (Jan 19). doi: 10.1007/s10549-023-07207-4 Source

Key clinical point: Addition of veliparib vs placebo to carboplatin + paclitaxel did not significantly improve the overall survival (OS) outcomes in patients with BRCA1/2-mutated human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A combination of veliparib and carboplatin + paclitaxel vs placebo + carboplatin + paclitaxel led to numerical but nonsignificant improvements in median OS (32.4 vs 28.2 months; hazard ratio 0.916; P = .434). The addition of veliparib was generally well-tolerated, consistent with previous findings.

Study details: Findings are from the phase 3 BROCADE3 trial which included 509 patients with BRCA1/2-mutated HER2− advanced BC who had received at least two prior lines of chemotherapy and were randomly assigned to receive carboplatin + paclitaxel with either veliparib or placebo.

Disclosures: This study was funded by AbbVie. No other disclosures were reported in this study.

Source: Diéras V, Han HS, Wildiers H, et al. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): Final overall survival results from a randomized phase 3 trial. Eur J Cancer. 2024;200:113580. doi: 10.1016/j.ejca.2024.113580 Source

Key clinical point: Addition of veliparib vs placebo to carboplatin + paclitaxel did not significantly improve the overall survival (OS) outcomes in patients with BRCA1/2-mutated human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A combination of veliparib and carboplatin + paclitaxel vs placebo + carboplatin + paclitaxel led to numerical but nonsignificant improvements in median OS (32.4 vs 28.2 months; hazard ratio 0.916; P = .434). The addition of veliparib was generally well-tolerated, consistent with previous findings.

Study details: Findings are from the phase 3 BROCADE3 trial which included 509 patients with BRCA1/2-mutated HER2− advanced BC who had received at least two prior lines of chemotherapy and were randomly assigned to receive carboplatin + paclitaxel with either veliparib or placebo.

Disclosures: This study was funded by AbbVie. No other disclosures were reported in this study.

Source: Diéras V, Han HS, Wildiers H, et al. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): Final overall survival results from a randomized phase 3 trial. Eur J Cancer. 2024;200:113580. doi: 10.1016/j.ejca.2024.113580 Source

Key clinical point: Addition of veliparib vs placebo to carboplatin + paclitaxel did not significantly improve the overall survival (OS) outcomes in patients with BRCA1/2-mutated human epidermal growth factor receptor 2-negative (HER2−) advanced breast cancer (BC).

Major finding: A combination of veliparib and carboplatin + paclitaxel vs placebo + carboplatin + paclitaxel led to numerical but nonsignificant improvements in median OS (32.4 vs 28.2 months; hazard ratio 0.916; P = .434). The addition of veliparib was generally well-tolerated, consistent with previous findings.

Study details: Findings are from the phase 3 BROCADE3 trial which included 509 patients with BRCA1/2-mutated HER2− advanced BC who had received at least two prior lines of chemotherapy and were randomly assigned to receive carboplatin + paclitaxel with either veliparib or placebo.

Disclosures: This study was funded by AbbVie. No other disclosures were reported in this study.

Source: Diéras V, Han HS, Wildiers H, et al. Veliparib with carboplatin and paclitaxel in BRCA-mutated advanced breast cancer (BROCADE3): Final overall survival results from a randomized phase 3 trial. Eur J Cancer. 2024;200:113580. doi: 10.1016/j.ejca.2024.113580 Source

Key clinical point: Treatment with toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel significantly improved progression-free survival (PFS) and showed an acceptable safety profile in patients with programmed death ligand-1 (PD-L1)-positive metastatic or recurrent triple-negative breast cancer (TNBC).

Major finding: Toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel led to a significantly longer PFS (median 8.4 vs 5.6 months) in patients with PD-L1-positive TNBC (hazard ratio 0.65; P = .0102) and similar incidences of grade ≥3 treatment-emergent adverse events (56.4% vs 54.3%) and fatal adverse events (0.6% vs 3.4%).

Study details: Findings are from the phase 3 TORCHLIGHT trial which included 531 patients with metastatic or recurrent locally advanced TNBC who were previously untreated or treated with up to one systemic chemotherapy and were randomly assigned to receive toripalimab + nab-paclitaxel or placebo + nab-paclitaxel. Of these, 300 patients had PD-L1-positive TNBC.

Disclosures: This study was sponsored by Shanghai Junshi Biosciences and supported by other sources. Five authors declared being employees of Shanghai Junshi Biosciences or TopAlliance Biosciences. The other authors declared no competing interests.

Source: Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: A randomized phase 3 trial. Nat Med. 2024;30:249-256. doi: 10.1038/s41591-023-02677-x Source

Key clinical point: Treatment with toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel significantly improved progression-free survival (PFS) and showed an acceptable safety profile in patients with programmed death ligand-1 (PD-L1)-positive metastatic or recurrent triple-negative breast cancer (TNBC).

Major finding: Toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel led to a significantly longer PFS (median 8.4 vs 5.6 months) in patients with PD-L1-positive TNBC (hazard ratio 0.65; P = .0102) and similar incidences of grade ≥3 treatment-emergent adverse events (56.4% vs 54.3%) and fatal adverse events (0.6% vs 3.4%).

Study details: Findings are from the phase 3 TORCHLIGHT trial which included 531 patients with metastatic or recurrent locally advanced TNBC who were previously untreated or treated with up to one systemic chemotherapy and were randomly assigned to receive toripalimab + nab-paclitaxel or placebo + nab-paclitaxel. Of these, 300 patients had PD-L1-positive TNBC.

Disclosures: This study was sponsored by Shanghai Junshi Biosciences and supported by other sources. Five authors declared being employees of Shanghai Junshi Biosciences or TopAlliance Biosciences. The other authors declared no competing interests.

Source: Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: A randomized phase 3 trial. Nat Med. 2024;30:249-256. doi: 10.1038/s41591-023-02677-x Source

Key clinical point: Treatment with toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel significantly improved progression-free survival (PFS) and showed an acceptable safety profile in patients with programmed death ligand-1 (PD-L1)-positive metastatic or recurrent triple-negative breast cancer (TNBC).

Major finding: Toripalimab + nab-paclitaxel vs placebo + nab-paclitaxel led to a significantly longer PFS (median 8.4 vs 5.6 months) in patients with PD-L1-positive TNBC (hazard ratio 0.65; P = .0102) and similar incidences of grade ≥3 treatment-emergent adverse events (56.4% vs 54.3%) and fatal adverse events (0.6% vs 3.4%).

Study details: Findings are from the phase 3 TORCHLIGHT trial which included 531 patients with metastatic or recurrent locally advanced TNBC who were previously untreated or treated with up to one systemic chemotherapy and were randomly assigned to receive toripalimab + nab-paclitaxel or placebo + nab-paclitaxel. Of these, 300 patients had PD-L1-positive TNBC.

Disclosures: This study was sponsored by Shanghai Junshi Biosciences and supported by other sources. Five authors declared being employees of Shanghai Junshi Biosciences or TopAlliance Biosciences. The other authors declared no competing interests.

Source: Jiang Z, Ouyang Q, Sun T, et al. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: A randomized phase 3 trial. Nat Med. 2024;30:249-256. doi: 10.1038/s41591-023-02677-x Source

Key clinical point: In patients with platinum-pretreated advanced triple-negative breast cancer (TNBC), a chemotherapy-free maintenance regimen containing olaparib with or without durvalumab vs continued platinum-based chemotherapy led to a greater improvement in progression-free survival (PFS) with no new safety signals.

Major finding: The median PFS was 4.0 months with olaparib and 6.1 months with olaparib + durvalumab, with both treatments providing greater PFS benefit than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). No treatment-related deaths or new safety signals were reported.

Study details: Findings are from the phase 2 DORA trial which included 45 patients with advanced TNBC who had stable disease or complete or partial response after receiving platinum-based chemotherapy and were randomly assigned to receive olaparib or olaparib + durvalumab.

Disclosures: This study was supported by AstraZeneca Pharmaceuticals LP. Some authors declared receiving honoraria, research funding, or fees; owning stocks; or having other ties with AstraZeneca and various other sources.

Source: Tan TJ, Sammons S, Im YH, et al. Phase II DORA study of olaparib with or without durvalumab as a chemotherapy-free maintenance strategy in platinum-pretreated advanced triple-negative breast cancer. Clin Cancer Res. 2024 (Jan 18). doi: 10.1158/1078-0432.CCR-23-2513 Source

Key clinical point: In patients with platinum-pretreated advanced triple-negative breast cancer (TNBC), a chemotherapy-free maintenance regimen containing olaparib with or without durvalumab vs continued platinum-based chemotherapy led to a greater improvement in progression-free survival (PFS) with no new safety signals.

Major finding: The median PFS was 4.0 months with olaparib and 6.1 months with olaparib + durvalumab, with both treatments providing greater PFS benefit than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). No treatment-related deaths or new safety signals were reported.

Study details: Findings are from the phase 2 DORA trial which included 45 patients with advanced TNBC who had stable disease or complete or partial response after receiving platinum-based chemotherapy and were randomly assigned to receive olaparib or olaparib + durvalumab.

Disclosures: This study was supported by AstraZeneca Pharmaceuticals LP. Some authors declared receiving honoraria, research funding, or fees; owning stocks; or having other ties with AstraZeneca and various other sources.

Source: Tan TJ, Sammons S, Im YH, et al. Phase II DORA study of olaparib with or without durvalumab as a chemotherapy-free maintenance strategy in platinum-pretreated advanced triple-negative breast cancer. Clin Cancer Res. 2024 (Jan 18). doi: 10.1158/1078-0432.CCR-23-2513 Source

Key clinical point: In patients with platinum-pretreated advanced triple-negative breast cancer (TNBC), a chemotherapy-free maintenance regimen containing olaparib with or without durvalumab vs continued platinum-based chemotherapy led to a greater improvement in progression-free survival (PFS) with no new safety signals.

Major finding: The median PFS was 4.0 months with olaparib and 6.1 months with olaparib + durvalumab, with both treatments providing greater PFS benefit than the historical control of continued platinum-based therapy (P = .0023 and P < .0001, respectively). No treatment-related deaths or new safety signals were reported.

Study details: Findings are from the phase 2 DORA trial which included 45 patients with advanced TNBC who had stable disease or complete or partial response after receiving platinum-based chemotherapy and were randomly assigned to receive olaparib or olaparib + durvalumab.

Disclosures: This study was supported by AstraZeneca Pharmaceuticals LP. Some authors declared receiving honoraria, research funding, or fees; owning stocks; or having other ties with AstraZeneca and various other sources.

Source: Tan TJ, Sammons S, Im YH, et al. Phase II DORA study of olaparib with or without durvalumab as a chemotherapy-free maintenance strategy in platinum-pretreated advanced triple-negative breast cancer. Clin Cancer Res. 2024 (Jan 18). doi: 10.1158/1078-0432.CCR-23-2513 Source

Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).

Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).

Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.

Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.

Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038  Source

Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).

Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).

Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.

Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.

Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038  Source

Key clinical point: Neoadjuvant endocrine therapy with fulvestrant or anastrozole + fulvestrant led to an endocrine-sensitive disease rate (ESDR) comparable to anastrozole alone in postmenopausal women with estrogen receptor (ER)-rich, human epidermal growth factor receptor 2-negative (ERBB2−) breast cancer (BC).

Major finding: Both fulvestrant and anastrozole + fulvestrant vs anastrozole alone demonstrated no significant improvement in the ESDR at 6 months (22.8% and 20.5% vs 18.7%, respectively; Wald test, P ≥ .98) and median percentage change in Ki67 at 4 weeks (−79.1% and −83.5% vs −80.6%, respectively; P ≥ .15).

Study details: Findings are from the phase 3 ALTERNATE trial, which included 1298 treatment-naive postmenopausal women with ER-rich/ERBB2− BC who were randomly assigned to receive anastrozole, fulvestrant, or anastrozole + fulvestrant for 6 months in a neoadjuvant setting.

Disclosures: This study was supported by the US National Institutes of Health (NIH)/National Cancer Institute (NCI) and other sources. Several authors declared receiving grants, personal fees, or research support or having other ties with various sources, including NIH/NCI.

Source: Ma CX, Suman VJ, Sanati S, et al. Endocrine-sensitive disease rate in postmenopausal patients with estrogen receptor-rich/ERBB2-negative breast cancer receiving neoadjuvant anastrozole, fulvestrant, or their combination: A phase 3 randomized clinical trial. JAMA Oncol. 2024 (Jan 18). doi: 10.1001/jamaoncol.2023.6038  Source

Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.

Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.

Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.

Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.

Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source

Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.

Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.

Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.

Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.

Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source

Key clinical point: High initial fat body mass was associated with a risk for vertebral fracture (VF) progression in postmenopausal women with hormone receptor-positive (HR+) early breast cancer (BC) who received aromatase inhibitors (AI) plus denosumab.

Major finding: After 18 months of adjuvant therapy with AI and denosumab, 4.4% of patients had VF progression, with percentage of fat body mass (odds ratio [OR] 5.41; P = .01) and Fracture Risk Assessment Tool score (OR 3.95; P = .04) being independently associated with VF progression risk.

Study details: Findings are from a prospective cohort study including 237 postmenopausal women with HR+ early BC who received adjuvant therapy with AI and denosumab.

Disclosures: This study did not declare any specific funding. Three authors declared receiving personal fees or grants or having other ties with various sources.

Source: Cosentini D, Pedersini R, Mauro PD, et al. Fat body mass and vertebral fracture progression in women with breast cancer. JAMA Netw Open. 2024;7:e2350950. doi:10.1001/jamanetworkopen.2023.50950 Source