NCT03881878

TAHP for Patients With HER2-positive Early Breast Cancer and Subsequent AHP Adjuvant tHerapy After Surgery

Docetaxel Plus Atezolizumab Plus Herceptin SC and Pertuzumab (TAHP) for Patients With HER2-positive Early Breast Cancer and Subsequent Atezolizumab Plus Herceptin SC and Pertuzumab (AHP) Adjuvant tHerapy After Surgery

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 67 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study was phase IB-II clinical trial that designed to evaluate the efficacy and safety of docetaxel + atezolizumab + Herceptin sc plus pertuzumab(TAHP) plus adjuvant therapy of atezolizumab + trastuzumab + pertuzumab(AHP) after surgery in female patients with HER2-positive early breast cancer. Adjuvant AHP (atezolizumab + Herceptin SC + pertuzumab) will be continued for remaining 1 year. For non-p CR patients, they are going to treat with 4 cycles of AC rather than Taxane only before AHP adjuvant therapy.

Detailed 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 \[patients with pCR\] * 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

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	TAHP and AHP	(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks * Docetaxel (75mg/m2, IV) * Atezolizumab (1200mg, IV) * Tastuzumab (600mg, SC) * Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV) (B, Adjuvant setting) : patients with pCR:D1 X 11-12 cycles, q3weeks * Atezolizumab (1200mg, IV) * Trastuzumab (600mg, SC) * Pertuzumab (420mg, IV)
DRUG	TAHP plus AC and AHP	(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks * Docetaxel (75mg/m2, IV) * Atezolizumab (1200mg, IV) * Tastuzumab (600mg, SC) * Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV) (B, Adjuvant setting) : patients with non-pCR * Doxorubicin(60mg/m2) plus cyclophosphamide (600mg/m2) D1 X 4cycles q3weeks followed by * Atezolizumab (1200mg, IV), Trastuzumab (600mg, SC) and Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks

Timeline

• Start date: 2019-05-27
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2019-03-20
• Last updated: 2019-03-21

Locations

1 site across 1 country: South Korea