Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC
This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.
• Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
• Female subjects 18 years of age or older
• Histologically confirmed cT1c-T3N0, cT1-T3N1-N2, cTxN1-2 TNBC
‣ The invasive tumor must be hormone receptor poor, defined as both estrogen receptor (ER) and progesterone receptor staining in ≤ 10% of invasive cancer cells by IHC
⁃ The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines
• No previous ipsilateral breast surgery for the current breast cancer
• No previous chemotherapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer
• ECOG Performance Status 0 - 1 documented within 21 days prior to the start of study treatment
• Breast and axillary imaging (including ultrasound and MRI) within 42 days (6 weeks) prior to treatment initiation
• Subjects with clinically and/or radiographically abnormal axillary or internal mammary lymph nodes should have pathologic confirmation of disease status with image-guided biopsy or fine needle aspiration
• Archival breast tumor tissue has been obtained or has been requested for use
• No clinically apparent metastatic disease. Staging to rule out metastatic disease is suggested for patients with clinical TNM stage III disease
• Subjects with bilateral synchronous TNBC are eligible if they meet other eligibility criteria
• No baseline neuropathy greater than grade 2
• Patients are not pregnant, not breastfeeding, and either not a woman of childbearing potential or agrees to follow specific contraceptive guidelines during the treatment period and for at least 120 days after the last dose of study treatment
• Adequate hematologic, hepatic, and renal function assessed ≤ 21 days from treatment initiation
• Only if assigned to Regimen C, LVEF ≥ 50% by echocardiogram or MUGA scan, per standard of care (assessed within 120 days prior to receiving doxorubicin + cyclophosphamide)