Study on Ribociclib and Hormone Therapy for Early HR+/HER2- Breast Cancer
Sponsor: Novartis Pharmaceuticals
ClinicalTrials ID:NCT03701334
This clinical trial is testing the effectiveness and safety of combining ribociclib with hormone therapy as an additional treatment for patients with early-stage HR+/HER2- breast cancer after surgery and other standard treatments.
Patient Parameters
| Parameter | Options |
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Program Overview
The study aims to find out if adding ribociclib to hormone therapy can help treat early-stage HR+/HER2- breast cancer more effectively. It involves patients who have already had surgery to remove the cancer and may have received chemotherapy or radiation. The trial will include about 5,000 participants who will be randomly assigned to receive either the combination treatment or standard hormone therapy alone. The study will have different phases, including screening, treatment, and follow-up.
Description
This trial is for women and men with early-stage HR-positive, HER2-negative breast cancer. Participants must have had surgery to remove the cancer and may have also received chemotherapy or radiation if needed. The study will test if adding ribociclib to hormone therapy can improve treatment outcomes. About 5,000 participants will be randomly divided into two groups: one will receive ribociclib with hormone therapy, and the other will receive hormone therapy alone. The trial will include screening, treatment, and follow-up phases to monitor the safety and effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must be female with known menopausal status or male.
- Must have a confirmed diagnosis of HR-positive, HER2-negative breast cancer.
- Cancer must have been completely removed by surgery.
- Must have completed any necessary chemotherapy or radiation.
- Must have a good overall health status (ECOG score of 0 or 1).
- Must be eligible for hormone therapy for at least 5 years.
Exclusion Criteria
- Have used any CDK4/6 inhibitor before.
- Have used certain hormone therapies for breast cancer prevention or osteoporosis in the last 2 years.
- Have had high doses of certain chemotherapy drugs.
- Have an allergy to ribociclib or hormone therapy ingredients.
- Have cancer that has spread beyond nearby lymph nodes.
- Are using other cancer treatments besides hormone therapy.
- Have had major surgery, chemotherapy, or radiation recently.
- Have not recovered from side effects of previous cancer treatments.
- Have another invasive cancer or had one treated within the last 2 years.
- Have HIV, Hepatitis B, or C.
- Have serious heart problems.
- Are taking certain medications or supplements that affect how the body processes drugs.
- Are taking or have recently taken corticosteroids.
- Have digestive issues that affect medication absorption.
- Have any other serious health condition that could affect safety or participation.
- Are participating in other drug studies or medical research.
- Are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the trial.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of Alabama at Birmingham-Kirklin Clinic | 35294-0006 | Birmingham | Alabama |
| Cancer Treatment Centers of America | 85338 | Goodyear | Arizona |
| St Bernards Medical Center | 72401 | Jonesboro | Arkansas |
| Comprehensive Blood and Cancer | 93309 | Bakersfield | California |
| UCLA Beverly Hills | 90212 | Beverly Hills | California |
| UCLA Burbank | 91505 | Burbank | California |
| Encino Research Center | 91436 | Encino | California |
| St. Jude Heritage Medical Group | 92835 | Fullerton | California |
| UCLA Hematology Oncology | 92653 | Laguna Hills | California |
| Southern CA Oncology Rsrch Alliance | 90057 | Los Angeles | California |
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