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Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR)

A Phase II Study of Ribociclib and Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

  • Clinical Trial Information

    Trial Contact: Ribacchi, Stephanie; Durand, Jennifer

    Trial Phone: 321-841-1077 ; 321.843.2026

  • IRB No: 20226221

    Protocol Abbrev: HCRN BRE20-468

    Principal Investigator: Ana Elisa Cuesta Fernandez, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: HCRN BRE20-468

    Treatment: Drug: Ribociclib 600 mg orally once daily Days 1-21 (28 day Cycle) Other Name: Kisqali Drug: Fulvestrant 500 mg intramuscularly on Day 1 and 15 of Cycle 1 then Day 1 of Cycle 2+ Other Name: Faslodex Drug: Anastrozole 1 mg orally once daily Other Name: Arimidex Drug: Letrozole 2.5 mg orally once daily Other Name: Femara Drug: Exemestane 25 mg orally once daily Other Name: Aromasin

    ClinicalTrials.gov ID: NCT05467891

  • Objective

    To estimate subsequent recurrence-free survival (RFS) at 3 years for Ribociclib when administered with ET (AIs or Fulvestrant), in patients with Hormone Receptor (HR) positive, HER2 negative breast cancer with adequately resected local recurrence of early breast cancer (EBC).

  • Key Eligibility

    Eligibility Criteria to Collect Optional Correlative Blood and Tissue at 1st Recurrence.
    •   Written informed consent (stage I) and HIPAA authorization for release of personal health information obtained prior to performing any study-specific procedures. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
    •   Male or female age ≥ 18 years at the time of consent.
    •   Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory.
    •   Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample.
    •   Patient has locoregional recurrence of breast cancer: locoregional recurrence is defined as invasive recurrence in the ipsilateral breast, axilla, regional nodes, and chest wall.