Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 21, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT03644186). This is a study registration, not published results. Lead sponsor: ETOP IBCSG Partners Foundation. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 147 participants (ACTUAL). Conditions: Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer. Interventions: DRUG: Paclitaxel; DRUG: Trastuzumab; DRUG: Pertuzumab; DRUG: Palbociclib; DRUG: Letrozole; DRUG: Trastuzumab; DRUG: Pertuzumab. Primary outcome measures: Pathological Complete Response (pCR) , Assessed within 30 days of the time of breast surgery after completion of a treatment period of up to 16 weeks; up to 21 weeks. If the patient does not undergo surgery, assessment will occur within 30 days after all treatment is stopped; up to 30 weeks.. Brief summary: This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in combination with hormonal therapy and HER2 blockade, versus the treatment with paclitaxel in combination with HER2 blockade.