. 2024 Apr 29;16:17588359241248336. doi: 10.1177/17588359241248336

Table 1.

Key inclusion criteria.

Inclusion criteria
• Documented informed consent • Aged ⩾18 years at time of screening; male or female • Histologically confirmed invasive TNBC (per ASCO/CAP guidelines; based on local results) ○ Negative for ER with <1% of tumor cells positive for ER on IHC ○ Negative for PR with <1% of tumor cells positive for PR on IHC ○ Negative for HER2 with 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on in situ hybridization • Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy • Completed at least six cycles of neoadjuvant therapy containing anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab • No evidence of locoregional or distant relapse • Surgical removal of all clinically evident disease in the breast and lymph nodes • ECOG PS of 0 or 1 • Documented availability of FFPE tumor sample from residual invasive disease at surgery • No adjuvant systemic therapy • Radiotherapy (if indicated) delivered before the start of the study intervention • LVEF ⩾ 50% by either ECHO or MUGA scan within 28 days prior to randomization • Eligible for one of the therapy options listed as the investigator’s choice of therapy • No known germline BRCA1 or BRCA2 mutation • Adequate bone marrow reserve and organ function within 7 days before randomization • For women of childbearing potential, a negative serum pregnancy test

Inclusion criteria

• Documented informed consent
• Aged ⩾18 years at time of screening; male or female
• Histologically confirmed invasive TNBC (per ASCO/CAP guidelines; based on local results)
○ Negative for ER with <1% of tumor cells positive for ER on IHC
○ Negative for PR with <1% of tumor cells positive for PR on IHC
○ Negative for HER2 with 0 or 1+ intensity on IHC, or 2+ intensity on IHC and no evidence of amplification on in situ hybridization
• Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy
• Completed at least six cycles of neoadjuvant therapy containing anthracycline and/or a taxane with or without carboplatin, with or without pembrolizumab
• No evidence of locoregional or distant relapse
• Surgical removal of all clinically evident disease in the breast and lymph nodes
• ECOG PS of 0 or 1
• Documented availability of FFPE tumor sample from residual invasive disease at surgery
• No adjuvant systemic therapy
• Radiotherapy (if indicated) delivered before the start of the study intervention
• LVEF ⩾ 50% by either ECHO or MUGA scan within 28 days prior to randomization
• Eligible for one of the therapy options listed as the investigator’s choice of therapy
• No known germline BRCA1 or BRCA2 mutation
• Adequate bone marrow reserve and organ function within 7 days before randomization
• For women of childbearing potential, a negative serum pregnancy test

ASCO/CAP, American Society of Clinical Oncology/College of American Pathologists; BRCA1/2, breast cancer gene 1/2; ECHO, echocardiogram; ECOG PS, Eastern Cooperative Oncology Group performance status; ER, estrogen receptor; FFPE, formalin-fixed paraffin-embedded; HER2, human epidermal growth factor receptor 2; IHC, immunohistochemistry; LVEF, left ventricular ejection fraction; MUGA, multigated acquisition; PR, progesterone receptor; TNBC, triple-negative breast cancer.