Study

A012303: ShortStop-HER2: Shortened Duration of Adjuvant Therapy in Patients with Early-Stage HER2+ Breast Cancer Who Achieve pCR After Neoadjuvant Chemotherapy with HER2 Blockade

PRIMARY OBJECTIVES: I. To evaluate whether 6 months of combined neoadjuvant (neo)/adjuvant HER2 blockade results in a non-inferior recurrence-free survival (RFS) compared to 12 months of combined neo/adjuvant HER2 blockade, in patients with early stage HER2+ breast cancer who achieve pCR after neoadjuvant chemotherapy with HER2 blockade. II. To compare the Functional Assessment of Cancer Therapy-Breast (FACT-B) total score at 12 months between patients randomized to receive 6 months versus 12 months of combined neo/adjuvant HER2 blockade. (Quality of life)

Why this Research Matters

This phase III trial compares 6 months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab 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. Giving 6 months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.

Who can Participate

Adult

Inclusion Criteria: Patients (females and males) with clinical stage T1c-T3 (or Tx) and nodal stage N0-N1 (except T3N1 tumors, which are not eligible) Patients must have no residual invasive disease in the breast or lymph nodes after the completion of neoadjuvant therapy. Residual ductal carcinoma in situ (DCIS) is allowed. Patients with residual isolated tumor cells at surgery are considered node-positive and are not eligible HER2+ by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Central pathology review is not required. In cases where there were multiple tumor sites in breast/nodes that had HER2 testing at diagnosis, at least one site must have been HER2+ AND the treating investigator must feel it is in the patient's best interest to be treated as having HER2+ breast cancer Known hormone receptor status as defined by ASCO/CAP guidelines. Estrogen receptor (ER) and progesterone receptor (PR) of any values are allowed. Hormone receptor positive status can be determined by either known positive ER or known positive PR status; hormone receptor negative status must be determined by both known negative ER and known negative PR Detailed eligibility criteria is available on ClinicalTrials.gov. These requirements will be discussed with your doctor and/or study representative. ClinicalTrials.gov to learn more about this study.