A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC)

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05035836
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Zanidatamab — DRUG
    Given IV
  • Letrozole — DRUG
    Given by PO
  • Tamoxifen — DRUG
    Given by PO

Study Details

This is a Phase 2, single-site, single-arm open-label trial of zanidatamab in patients with early stage, low risk HER2+ BC. The primary objective is to determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR) .

Key Dates

Start date
Nov 16, 2021
Status verified
Jun 2026
Primary completion
Dec 29, 2028
Completion
Dec 29, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zanidatamab
    zanidatamab by vein every 2 weeks (+/- 3 days) for up to 6 doses (3 study cycles

Primary Outcome Measure

To determine the efficacy of zanidatamab for patients with early stage HER2/neu positive (HER2+) breast cancer (BC) as determined by pathologic complete response (pCR [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Vicente Valero
[email protected]
713-563-0751
Vicente Valero (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

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

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