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.
EARLY HER2 POSITIVE (+) BREAST CANCER COHORT: Female or male with a diagnosis of biopsy proven invasive breast cancer HER2+, hormone (estrogen and progesterone)-receptor positive or negative. The HER2 status (following American Society of Clinical Oncology [ASCO]/College of American Pathologists [CAP] guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines
EARLY TNBC COHORT: Female or male with a diagnosis of biopsy proven invasive TNBC (estrogen and progesterone receptor < 10%). The HER2 status (following ASCO/CAP guidelines) and hormone-receptor status will be determined according to institutional (local) guidelines
FOR BOTH HER2+ AND TNBC COHORTS: Invasive breast cancer of any tumor histologic grade and/or nuclear grade, and any tumor histological subtype including but not limited to infiltrating ductal carcinoma, infiltrating lobular carcinoma, mucinous carcinoma, papillary carcinoma, tubular carcinoma, metaplastic carcinoma, and mixed histology
FOR BOTH HER2+ AND TNBC COHORTS: Clinical tumor stage (per American Joint Committee on Cancer [AJCC] 8th edition): T1-4, N0-2a, M0. Patients who have a diagnosis of inflammatory breast cancer are eligible. Patients should not have clinical evidence of locoregional or distant metastatic breast cancer
Patients with tumor stage of cN2b or cN3 are not eligible
History of other malignancies besides breast cancer within the past 5 years, except cervical cancer in situ, melanoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin
Patients who are receiving any other anti-cancer investigational agents
Patients with known cancer metastases from any site
Parallel
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Hormone Therapy
DrugGiven standard of care endocrine therapy
Pembrolizumab
Biological/VaccineGiven pembrolizumab
Pertuzumab
Biological/VaccineGiven pertuzumab
Trastuzumab
Biological/VaccineGiven trastuzumab
Event free survival (EFS)
Will be independently estimated for each cohort, along with corresponding 95% confidence intervals using Kaplan-Meier method.
Rate of conversion from negative to positive circulating tumor deoxyribonucleic acid (ctDNA)
95% confidence interval will be calculated by cohort using the Clopper-Pearson method.
Time to conversion from negative to positive ctDNA
Will be estimated using the Kaplan-Meier method.
Prevalence of patients with pathologic complete response (pCR) rate after receiving neoadjuvant systemic therapy (NST) and have positive ctDNA
The 95% confidence intervals for the prevalence estimates will be calculated using Clopper-Pearson method.
EFS in patients that achieve pCR after NST and have a positive ctDNA
EFS at 3 years with their 95% confidence intervals will be estimated using Kaplan-Meier method. Log-rank test will be performed to test the difference in time-to-event distributions between patient groups.
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