Ph2 Study for Optimization of Adjunct Systemic Therapy in HER2+ Patients, MolecularPCR Trial

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07407920
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Early Stage HER2-Positive Breast Carcinoma
  • Early Stage Triple-Negative Breast Carcinoma

Eligibility Criteria

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

Interventions

  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Hormone Therapy — DRUG
    Given standard of care endocrine therapy
  • Pembrolizumab — BIOLOGICAL
    Given pembrolizumab
  • Pertuzumab — BIOLOGICAL
    Given pertuzumab
  • Trastuzumab — BIOLOGICAL
    Given trastuzumab

Study Details

This phase II trial tests reduced post surgery (adjuvant) therapy for patients with early breast cancer who have confirmed that the disease has responded completely (pathologic complete response) after pre surgical treatment (neoadjuvant) therapy and do not have any tumor genetic material (molecular residual disease) circulating in their blood. Standard of care treatment after surgery consists of 1 year of pembrolizumab for patients with triple negative breast cancer or trastuzumab with or without pertuzumab to complete 1 year of treatment. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pertuzumab and trastuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When pertuzumab or trastuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Lowering the total amount of cancer therapy after breast surgery, may continue to keep the great tumor response to treatment, and may help lower the amount of side effects patients have.

Key Dates

Start date
Oct 9, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1 (Triple negative breast cancer)
    Patients may receive 1 to 3 cycles of standard of care treatment with pembrolizumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression. Patients undergo blood sample collection throughout the study.
  • Experimental: Cohort 2 (HER2 positive breast cancer)
    Patients may receive 1 to 3 cycles of standard of care treatment with trastuzumab with or without pertuzumab. Patients with a positive ctDNA test 4-6 weeks after surgery continue to receive standard of care treatment per their treating physician in the absence of disease progression or unacceptable toxicity. Patients with a negative ctDNA test will not receive further treatment with pembrolizumab and will undergo monitoring with ctDNA tests every 3 months for 3 years in the absence of disease progression. Patients may receive standard of care endocrine therapy per their treating physician throughout the study. Patients undergo blood sample collection throughout the study.

Primary Outcome Measure

Event free survival (EFS) [ Time Frame: From breast surgery to evidence of clinical locoregional or distant recurrence of breast cancer or death from breast cancer, up to 3 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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By research site
M D Anderson Cancer Center· Houston, TX

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