Actively Recruiting
Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
Led by Yale University · Updated on 2025-07-14
140
Participants Needed
1
Research Sites
268 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with ability and willingness to consent
- Have ipsilateral or contralateral synchronous breast cancer if highest stage tumor meets entry criteria
- Have multicentric or multifocal breast cancer if highest stage tumor meets entry criteria
- Have undergone total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or lumpectomy
- Lumpectomy margins free of invasive tumor and DCIS with no ink on tumor; additional excisions allowed if needed
- Mastectomy margins free of residual gross tumor; microscopic positive margins eligible if chest wall radiation planned
- Have undergone axillary staging with sentinel node biopsy, targeted axillary dissection, or axillary lymph node dissection
- Postoperative staging: men or premenopausal women with T1-3N1-2; postmenopausal women with T3N1 or T1-3N2
- Tumor is ER-positive (≥ 10%) and HER2-negative by current guidelines
- Oncotype Dx Recurrence Score 0 to 25
- Known menopausal status at screening
- Interval between last breast cancer surgery and screening no more than 16 weeks
- HIV-infected with undetectable viral load within 6 months and on stable antiretroviral therapy without drug interaction
- Radiation therapy used according to standard guidelines
- ECOG performance status 0 to 1 within 28 days before treatment
- Able to swallow oral medications
- Adequate organ and marrow function with specified laboratory values within 14 days prior to screening
- Standard 12-lead ECG with QTcF interval < 450 msec and resting heart rate 50-90 bpm
- Willing and able to comply with study visits, treatment, and procedures
- Not pregnant or breastfeeding and following specified reproductive and contraceptive requirements
- No contraindication to adjuvant endocrine therapy planned for five years or more
You will not qualify if you...
- Evidence of distant metastases or breast cancer recurrence after surgery
- T4 tumors including inflammatory breast cancer
- N3 tumors
- Prior neoadjuvant chemotherapy or biotherapy
- Prior tamoxifen, raloxifene, or aromatase inhibitors for chemoprevention or osteoporosis treatment within last 2 years
- Concurrent hormone replacement therapy
- Known hypersensitivity to ribociclib or endocrine therapy excipients
- History of invasive breast cancer other than synchronous or previous DCIS or LCIS
- Prior treatment with any CDK4/6 inhibitor
- Concurrent or recent invasive malignancy within 2 years (except certain skin or cervical cancers)
- Known active hepatitis B or C infection
- Life expectancy less than 10 years from other medical conditions
- Non-epithelial breast cancers such as sarcoma or lymphoma
- Use of hormonal contraceptives including progestin IUDs prior to registration
- Pregnancy, breastfeeding, or planning pregnancy during the trial
- Significant uncontrolled heart disease or cardiac abnormalities
- Use of medications or supplements that strongly affect CYP3A4/5 metabolism
- Recent systemic corticosteroid use within 2 weeks before treatment start without full recovery
- Gastrointestinal disorders affecting oral drug absorption
- Other uncontrolled severe medical conditions or limited life expectancy
- Participation in other investigational drug studies within 30 days or incompatible medical research without sponsor agreement
AI-Screening
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Trial Site Locations
Total: 1 location
1
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
Research Team
S
Stephanie Ladd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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