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

NCT03881878 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2019-03-21

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-27
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03881878 on ClinicalTrials.gov