Women's MoonShot: Neoadjuvant Treatment With PaCT for Patients With Locally Advanced TNBC

Inclusion Criteria

• Patients must have an intact evaluable primary tumor or biopsy proven axillary node involvement with at least 1.0 centimeter (cm) smallest dimension based on imaging after neoadjuvant anthracycline-based chemotherapy and prior to initiation of neoadjuvant chemotherapy under this protocol; baseline measurements and evaluations must be obtained within 4 weeks of registration to the study; all areas of disease should be recorded in order to assess response and uniformity of response to therapy
• Triple-negative breast cancer defined as estrogen receptor (ER) = 50% within 6 weeks prior to initiation of neoadjuvant chemotherapy
• Serum creatinine = = 50 mL/min calculated by the Cockcroft-Gault method
• Absolute neutrophil count (ANC) >= 1500/mm^3
• Platelets >= 100,000/mm^3
• Hemoglobin >= 9.0 g/dL
• Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) grade 1
• Patients with a history of serious cardiac events defined as: New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina or cerebrovascular accident (CVA) within 6 months of protocol registration
• Patients with a history of PR prolongation or atrioventricular (AV) block
• Patients with a history of prior therapy with paclitaxel and/or carboplatin
• Patients who have received a cumulative dose of doxorubicin of greater than 360 mg/m^2 or epirubicin of greater than 640 mg/m^2
• Patients who concurrently use hormonal therapy and/or concurrent radiation therapy
• Patients who had prior radiation therapy of the primary breast carcinoma or axillary lymph nodes
• Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must use highly effective methods of contraception during the study and 8 weeks after; highly effective contraception methods include combination of any two of the following: placement of an intrauterine device (IUD) or intrauterine system (IUS), barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository, total abstinence or male/female sterilization; women are considered post-menopausal and not of child-bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks prior to treatment; in the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child-bearing potential
• Male patients whose sexual partner(s) are WOCBP who are not willing to use adequate contraception, during the study and for 8 weeks after the end of treatment
• Negative serum or urine pregnancy test for women within 72 hours of receiving the first dose of the study medication for women of childbearing potential