A Translational Randomized Phase III Study Exploring the Effect of the Addition of Capecitabine to Carboplatine Based Chemotherapy in Early Triple Negative Breast Cancer
Primary aim: To compare the effect on pathologic complete response (pCR) rate of adding capecitabine to carboplatin based preoperative chemotherapy in early ER-negative and HER2-negative breast cancer. Pembrolizumab is allowed in both arms after approval for TNBC 2022.
• Signed written informed consent approved by the Ethical Review Board (IRB).
• Age ≥ 18 to \< 76 years.
• Histologically confirmed unilateral adenocarcinoma of the breast where neoadjuvant chemotherapy followed by definitive surgery is planned.
• Node positive disease (N1-3) or if clinically N0 Tumor size \>20 mm. When deciding T-stage the following hierarchy applies,
∙ MRI
‣ Ultrasound
‣ Mammography
‣ Clinical examination
• ER negative tumor defined by at least one the following:
∙ ER \< 1% cells positive by immunohistochemistry (IHC) or ER ≤ 10% cells positive by IHC and basal-like subtype using gene expression analysis
‣ ER \< 10% cells positive by IHC and PgR \< 10% cells positive by IHC
• HER2-normal tumor defined according to applicable national guidelines
• Consent for germline mutation screening for BRCA1, BRCA2 and other inherited breast cancer associated genes.
• WHO performance status 0 or 1.
• Negative pregnancy test in women of childbearing potential (premenopausal or \<12 months of amenorrhea post-menopause and who have not undergone surgical sterilization).
⁃ Willingness of female patients of childbearing potential, male patients, and their sexual partners to use an effective means of contraception during the treatment period and at least 6 months thereafter.
⁃ Willingness by the patient to undergo treatment and study related procedures according to the protocol.