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De-Escalation of Adjuvant Chemotherapy in HER2-positive, Estrogen Receptor-negative, Node-negative Early Breast Cancer Patients Who Achieved Pathological Complete Response After Neoadjuvant Chemotherapy and Dual HER2 Blockade
Other Non-Commercial Sponsor
Jules Bordet Institute
This is an open-label study with multiple phases. Eligible participants will receive neoadjuvant treatment with 12 administrations of weekly intravenous (IV) paclitaxel 80mg/m2 (or IV docetaxel 75mg/m2 every 3 weeks for 4 cycles), combined with subcutaneous injection (SC) fixed dose combination (FDC) of pertuzumab and trastuzumab (loading dose of 1200mg pertuzumab and 600mg trastuzumab, followed by 600mg pertuzumab and 60mg trastuzumab) every 3 weeks for 4 cycles. Following this, all participants will undergo surgery, performed according to local guidelines. After surgery, participants who achieve pathologic complete response (pCR, defined as pT0/Tis pN0) will receive adjuvant pertuzumab and trastuzumab FDC SC for an additional 14 cycles. Participants with residual invasive disease will receive salvage adjuvant trastuzumab emtansine (T-DM1, 3.6 mg/kg, IV every 3 weeks) for 14 cycles. In participants whose residual invasive disease is classified per Residual Cancer Burden (RCB) score as ≥2, 3 to 4 cycles of anthracycline-based chemotherapy may be administered, at the investigator's discretion, before the 14 cycles of T-DM1.