Study on the Impact of Skipping Chemotherapy for ER-Positive, HER2-Negative Breast Cancer with Ribociclib and Hormone Therapy
Sponsor: Yale University
ClinicalTrials ID:NCT06953882
This clinical trial is exploring whether patients with a specific type of breast cancer can safely skip chemotherapy and instead use a combination of ribociclib and hormone therapy. The study focuses on patients whose cancer is less aggressive based on certain tests.
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Program Overview
This Phase II study is investigating if patients with estrogen receptor (ER)-positive, HER2-negative breast cancer can avoid chemotherapy and still effectively manage their cancer using ribociclib (Kisqali) and hormone therapy. The trial is for patients whose cancer has been surgically removed and shows a low risk of returning, as indicated by a specific test score (OncotypeDx 21-gene recurrence score RS 0-25). Participants can choose whether to include chemotherapy in their treatment plan. The study aims to see if skipping chemotherapy affects the continuation of ribociclib treatment and overall patient outcomes.
Description
This study is designed for patients with ER-positive, HER2-negative breast cancer that has spread to the lymph nodes but is considered less aggressive based on a specific test score. Typically, treatment includes surgery, radiation, chemotherapy, and hormone therapy. However, the benefit of chemotherapy for patients with a low test score is uncertain. This trial allows patients to choose whether to include chemotherapy in their treatment.
Participants will be divided into two groups: one group will receive ribociclib and hormone therapy, while the other group will receive chemotherapy followed by ribociclib and hormone therapy. The study will monitor how many patients continue ribociclib treatment after one year and assess the impact on quality of life and long-term outcomes.
The trial will enroll 70 participants in each group to ensure accurate results. It is expected that those who skip chemotherapy may have fewer side effects, better quality of life, and possibly better long-term outcomes.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older who can understand and sign a consent form.
- May have cancer in one or both breasts if the main tumor meets study criteria and does not require chemotherapy or HER2-targeted therapy.
- Must have had surgery to remove the breast cancer, with clear margins (no cancer cells at the edge of the removed tissue).
- Must have had lymph node evaluation.
- Cancer must be ER-positive (10% or more) and HER2-negative.
- Oncotype Dx Recurrence Score must be between 0 and 25.
- Must know menopausal status.
- Must start the study within 16 weeks of last breast cancer surgery.
- HIV-positive participants must have an undetectable viral load and be on stable treatment.
- Must have good organ function and be able to swallow pills.
- Must agree to use effective contraception during and after the study if of childbearing potential.
Exclusion Criteria
- Evidence of cancer spread beyond regional lymph nodes or recurrence after surgery.
- Certain large or aggressive tumors.
- Previous chemotherapy or biotherapy for breast cancer.
- Recent use of certain medications for breast cancer prevention or osteoporosis.
- Known allergies to study drugs.
- History of other invasive cancers within two years.
- Active hepatitis B or C infection.
- Life expectancy less than 10 years due to other conditions.
- Significant heart disease or abnormal heart rhythms.
- Use of certain medications that affect liver enzymes.
- Recent use of systemic corticosteroids.
- Gastrointestinal issues affecting drug absorption.
- Participation in other drug trials within 30 days.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Yale University | 06511 | New Haven | Connecticut |
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