TAHP for Patients With HER2-positive Early Breast Cancer and Subsequent AHP Adjuvant tHerapy After Surgery
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- HER2 Positive Breast Cancer
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: (A, Neoadjuvant setting): TAHP (Docetaxel, Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 6 cycles q3weeks, intravenous(IV) administration (B, Adjuvant setting) : patients with pCR: AHP(Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 11-12 cycles q3weeks patients with non-pCR: Doxorubicin plus cyclophosphamide: D1 X 4cycles q3weeks followed by AHP (Atezolizumab, Trastuzumab sc and Pertuzumab) D1 X 11-12 cycles q3weeksMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
A, Neoadjuvant setting); 6 cycles q3weeks, intravenous(IV) administration Docetaxel (75mg/m2, intravenous(IV)) Day(D)1 Atezolizumab (1200mg, IV) D1 Herceptin sc (600mg subcutaneous(SC))D1 Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg(IV))D1 B, Adjuvant setting : 11-12 cycles q3weeks [p...
A, Neoadjuvant setting); 6 cycles q3weeks, intravenous(IV) administration Docetaxel (75mg/m2, intravenous(IV)) Day(D)1 Atezolizumab (1200mg, IV) D1 Herceptin sc (600mg subcutaneous(SC))D1 Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg(IV))D1 B, Adjuvant setting : 11-12 cycles q3weeks [patients with pCR] Atezolizumab (1200mg, IV) Trastuzumab (600mg, SC) Pertuzumab (420mg, IV) D1 [patients with non-pCR] Doxorubicin(60mg/m2), cyclophosphamide (600mg/m2) D1 X 4cycles 3weeks Atezolizumab (1200mg, IV) Trastuzumab (600mg, SC) Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks
Tracking Information
- NCT #
- NCT03881878
- Collaborators
- Not Provided
- Investigators
- Not Provided
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