Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer

This phase Ib/II trial studies the side effects and best dose of ribociclib, tucatinib, and trastuzumab for the treatment of HER2 positive breast cancer that has spread to other parts of the body (metastatic), and then compares the effect of ribociclib, tucatinib, trastuzumab with or without fulvestrant to docetaxel, carboplatin, trastuzumab, and pertuzumab (standard of care) for the treatment of early stage breast cancer before surgery (neoadjuvant therapy). Ribociclib and tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Trastuzumab is a for

Trial Details

NCT ID
NCT05319873
Phase
PHASE1 / PHASE2
Sponsor
Jonsson Comprehensive Cancer Center
Status
RECRUITING
Cancer Type
ER/PR Positive (Hormone Receptor Positive) Breast Cancer
Interventions
  • Carboplatin
  • Docetaxel
  • Fulvestrant
  • Pertuzumab
  • Quality-of-Life Assessment
  • Ribociclib
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368

Key Eligibility Criteria

  • PHASE IB AND II: Patients over age of 18
  • PHASE IB AND II: Available archival tissue for confirmatory central HER2 testing. Results not required prior to enrollment.
  • PHASE IB AND II: Left ventricular ejection fraction (LVEF) \>= 50% based on echocardiogram or multigated acquisition (MUGA).
  • PHASE IB AND II: Platelet count \>= 100,000/mm\^3 (within 7 days before enrollment)

For full eligibility, visit ClinicalTrials.gov.

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