Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT03820141
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    programmed cell death-ligand 1 inhibitor
  • Trastuzumab — DRUG
    anti-HER2 monoclonal antibody
  • Pertuzumab — DRUG
    anti-HER2 monoclonal antibody

Study Details

The purpose of this research study is to test the safety and effectiveness of using durvalumab with trastuzumab and pertuzumab in participants with human epidermal growth factor receptor 2 (HER2)-enriched breast cancer.

Key Dates

Start date
Jun 30, 2020
Status verified
Apr 2026
Primary completion
Oct 30, 2024
Completion
Dec 31, 2028

Study Design

Enrollment
51 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Durvalumab + Trastuzumab + Pertuzumab
    Durvalumab, trastuzumab, and pertuzumab will be administered on Day 1 every 3 weeks for 6 cycles. Trastuzumab will be administered as 8 mg/kg intravenous (IV) loading dose, followed by 6 mg/kg IV. Pertuzumab will be administered as 840 mg IV loading dose, followed by 420 mg. Durvalumab will be administered at a fixed dose of 1120 mg IV.

Primary Outcome Measure

Pathological Response Rate (RCB-0 and RCB-1) Rate in the Breast in Patients With HER2-enriched and HER2-amplified Breast Cancer [ Time Frame: 18 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Houston Methodist Cancer Center· Houston, TX

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