Study on Ribociclib with Hormone Therapy for ER-positive Breast Cancer

Sponsor: Massachusetts General Hospital

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03285412

Provider View

This clinical trial is testing the drug Ribociclib, combined with hormone therapy, to see if it can effectively treat early-stage ER-positive breast cancer. The study involves checking for minimal residual disease using a blood test before starting treatment.

Patient Parameters

Program Overview

This study is exploring the use of Ribociclib, a drug that blocks certain proteins needed for cancer cells to grow, in combination with hormone therapy for treating early-stage ER-positive breast cancer. The trial aims to determine if this combination can effectively stop cancer cells from growing. Participants will undergo a pre-screening blood test to detect minimal residual disease before receiving the treatment. Ribociclib is already approved for use in advanced breast cancer, and this study is investigating its effectiveness in earlier stages.

Description

This Phase II clinical trial is designed to test the safety and effectiveness of Ribociclib, a drug that targets proteins called CDK4/6, which are involved in cell division and cancer growth. The study involves two parts: a pre-screening phase using a blood test to detect minimal residual disease, and a treatment phase where Ribociclib is combined with hormone therapy. There is no placebo in this study, meaning all participants will receive the active treatment. The goal is to see if Ribociclib can help stop the growth of cancer cells in patients with early-stage ER-positive breast cancer. Participants must have completed surgery for breast cancer and may have received previous chemotherapy or radiotherapy, provided they meet specific health criteria. The study is open to both premenopausal and postmenopausal women, and participants must be on hormone therapy during the trial. Ribociclib is already approved for use in advanced breast cancer, and this study aims to evaluate its potential benefits in earlier stages.

Eligibility Criteria

Inclusion Criteria

  • Must have ER-positive, HER2-negative invasive breast cancer confirmed by biopsy.
  • Cancer must be at a specific stage and have been surgically treated.
  • Detectable minimal residual disease in blood test.
  • No history of other cancers in the past 5 years, except for certain types like skin cancer or cervical cancer in situ.
  • Must be at least 4 weeks post-chemotherapy or radiotherapy with minimal side effects.
  • Open to premenopausal and postmenopausal women, with specific pregnancy testing requirements for premenopausal women.
  • Must be 18 years or older.
  • Previous use of CDK 4/6 inhibitors is allowed if it was over 12 months ago.
  • Must have good overall health and organ function based on specific lab tests.
  • Currently on hormone therapy, with specific guidelines for switching medications if needed.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Recent chemotherapy or radiotherapy within 4 weeks prior to the study.
  • Use of other investigational drugs.
  • Known brain metastases or other cancer spread.
  • Use of medications that affect the liver enzyme CYP3A4.
  • Uncontrolled illnesses or conditions that could interfere with the study.
  • Significant heart disease or abnormal heart rhythms.
  • Allergies to Ribociclib or its components.
  • HIV-positive individuals on antiretroviral therapy.
  • Pregnant or breastfeeding women.
  • Women of childbearing potential must use effective contraception during and after the study.
  • Men must also use contraception to prevent pregnancy in partners.

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