ShortStop-HER2: 12 Months vs. 6 Months of HER2-targeted Medications for People With HER2+ Breast Cancer Who Had a Pathologic Complete Response After Chemotherapy Plus Trastuzumab

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 c

Trial Details

NCT ID
NCT06876714
Phase
PHASE3
Sponsor
Alliance for Clinical Trials in Oncology
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Trastuzumab (Herceptin)
  • Pertuzumab
  • Echocardiography
  • Multigated Acquisition Scan
  • Mammography
  • Ultrasound
Locations (sample)
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Fort Smith, Arkansas, United States|35.38592,-94.39855
  • Jonesboro, Arkansas, United States|35.8423,-90.70428
  • Little Rock, Arkansas, United States|34.74648,-92.28959
  • Arroyo Grande, California, United States|35.11859,-120.59073

Key Eligibility 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…
  • HER2+ by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. Central pathology review is not required. …
  • Known hormone receptor status as defined by ASCO/CAP guidelines. Estrogen receptor (ER) and progesterone receptor (PR) of any values are allowed. H…

For full eligibility, visit ClinicalTrials.gov.

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