SELECT: A Phase II Adjuvant Trial Evaluating the Impact of Omitting Chemotherapy Based on Patient's Selection for Moderate to High-Anatomical Risk, Low-Genomic Risk, ER-Positive, HER2- Negative Breast Cancer With a Combination Regimen of Ribociclib and Optimized Endocrine Therapy
Yale University
Summary
This is a Phase II Trial to assess the impact of omitting adjuvant chemotherapy based on patient's selection on treatment persistence of CDK4/6 inhibitor, ribociclib (Kisqali), in a well-defined subgroup of patients with resected estrogen receptor (ER)-positive, HER2-negative, lymph node-positive breast cancer, but whose tumor profiling indicates a less aggressive biological nature (OncotypeDx 21-gene recurrence score RS 0-25).
Description
Most patients with ER-positive, HER2-negative, node-positive breast cancer are treated with curative intent, which typically involves some combination of surgery, radiation, endocrine therapy (ET) and often chemotherapy. The recent integration of CDK 4/6 inhibitors into adjuvant ET has complicated treatment decision-making for this subtype of breast cancer. These agents have demonstrated substantial benefits in reducing recurrence risk when combined with ET, prompting a reassessment of the role and necessity of chemotherapy in certain patient populations. However, it remains unclear to what ex…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Female or male age ≥ 18 years old and have the ability to understand and the willingness to sign a written informed consent document. 2. Participants may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy. 3. Participants may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease would not require chemotherapy or HER2-directed therapy. 4. Participants underw…
Interventions
- DrugRibociclib 400mg
400 mg (2 x 200 mg tablets by mouth) once daily on days 1 to 21 of a 28-day cycle, followed by seven days off ribociclib (Days 22 to 28).
- DrugLetrozole 2.5mg
Letrozole will be administered as an endocrine therapy. The regimen will differ depending on the demographic of the patient. For postmenopausal women: Letrozole 2.5 mg by mouth daily continuously. For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously.
- DrugAnastrazole 1mg
For postmenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously.
- DrugGoserelin 3.6 MG
For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, concurrently with goserelin 3.6 mg monthly injection.
- RadiationAdjuvant chemotherapy
Adjuvant chemotherapy dose modifications in Arm 2 will be per institutional guidelines and investigator discretion.
Location
- Yale UniversityNew Haven, Connecticut