Actively Recruiting
No Chemotherapy in Intermediate-risk HR HER2- Early Breast Cancer Treated With Ribociclib LEE-011 in the Adjuvant Setting, a Non-inferiority Phase III Trial
Led by UNICANCER · Updated on 2026-05-26
3902
Participants Needed
138
Research Sites
213 weeks
Total Duration
On this page
Sponsors
U
UNICANCER
Lead Sponsor
N
Novartis
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the use of ribociclib, a CDK46 inhibitor, in women with early hormone receptor-positive HR and HER2-negative breast cancer who are at intermediate risk of cancer recurrence. The study aims to see if patients can avoid chemotherapy, which has significant side effects, by using ribociclib along with hormone therapy after surgery. This phase III trial builds on the NATALEE study, which showed that ribociclib added to hormone therapy improved survival free of invasive disease in similar patients. Participants will be randomly assigned to one of two groups one receiving ribociclib plus endocrine hormone therapy, and the other receiving chemotherapy followed by ribociclib and endocrine therapy. Ribociclib treatment lasts for three years, and chemotherapy is given before starting ribociclib and hormone treatment. The trial aims to compare the outcomes of chemotherapy de-escalation versus standard treatment in this patient group. During the study, participants will attend scheduled visits for treatment and monitoring, including laboratory tests, heart monitoring with ECG, and questionnaires about their quality of life. Researchers will track invasive breast cancer-free survival and other outcomes such as overall survival and treatment side effects for up to 12 years. Safety and quality of life assessments will continue during and after treatment to evaluate the long-term effects and benefits of the treatment approaches.
CONDITIONS
Brief Title
Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent prior to any trial-specific screening procedure
- Female patient aged 18 years or older
- Known menopausal status at randomization, meeting defined post-menopausal criteria
- Histologically confirmed invasive breast carcinoma meeting specific pathological staging and ER-positive/HER2-negative status
- Eligible for chemotherapy based on investigator's assessment using clinicopathological findings or genomic signatures
- No contraindications for adjuvant endocrine therapy or chemotherapy and planned treatment with endocrine therapy for 5 years or more
- Curative surgery performed with negative surgical margins within 12 weeks before randomization (or planned revision if margins positive)
- Negative serum pregnancy test for women of childbearing potential
- Agreement to use effective contraception during treatment and up to 21 days after last dose
- ECOG performance status of 0 to 1 within 28 days prior to randomization
- Adequate hematological, renal, and hepatic function per specified laboratory values
- Standard 12-lead ECG with QTcF interval less than 450 milliseconds and resting heart rate between 50-100 bpm
- Willingness and ability to comply with scheduled visits, treatment plans, and trial procedures
- No psychological, familial, or geographical conditions likely to hamper compliance
- Affiliated to a Social Security System or equivalent
You will not qualify if you...
- Prior neoadjuvant chemotherapy or prior CDK4/6 inhibitor treatment
- Breast cancer diagnosed while on tamoxifen, raloxifene, or aromatase inhibitors for cancer risk reduction or osteoporosis treatment within 2 years prior
- Known hypersensitivity to ribociclib or endocrine therapy excipients
- Evidence or history of distant metastases, inflammatory breast cancer, recurrence, or second primary breast cancer
- Concurrent or recent invasive malignancy within 2 years (except certain skin or cervical cancers)
- Breast cancer considered endocrine therapy insensitive
- Major surgery within 14 days before study treatment
- Known HIV infection with contraindicated antiretroviral therapy
- Active hepatitis B or C infection
- Significant uncontrolled heart disease or abnormal cardiac findings
- Medical conditions increasing risk or interfering with study compliance
- History of pneumonitis
- Use of certain medications or supplements interfering with study drugs within 7 days prior
- Concurrent hormone replacement therapy or recent estrogen replacement
- Recent systemic corticosteroid use or incomplete recovery from corticosteroid side effects
- Other severe uncontrolled medical conditions or limited life expectancy
- Recent participation in incompatible investigational studies
- Inability or unwillingness to swallow oral pills
- Malabsorption syndromes affecting drug absorption
- Psychological, familial, sociological, or geographical factors impeding adherence
- Pregnant or breastfeeding women, or planning pregnancy or breastfeeding during treatment
- Persons deprived of liberty or under protective custody or guardianship
Research Team
S
Sandrine Marques
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