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Life sciences · Phase 2 Trial
ClinicalTrials.gov · September 24, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07407920). This is a study registration, not published results. Lead sponsor: M.D. Anderson Cancer Center. Recruitment status: RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). 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. Interventions: PROCEDURE: Biospecimen Collection; DRUG: Hormone Therapy; BIOLOGICAL: Pembrolizumab; BIOLOGICAL: Pertuzumab; BIOLOGICAL: Trastuzumab. Primary outcome measures: Event free survival (EFS) , From breast surgery to evidence of clinical locoregional or distant recurrence of breast cancer or death from breast cancer, up to 3 years. Brief summary: 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.