NCT06656624 Efficacy and Safety of Ribociclib Combined With AI Versus Physician&Amp;#39;s Choice of Chemotherapy Sequential Endocrine Therapy in ER Middle-low-expression/HER2-negative Advanced Breast Cancer (Rachel)
| NCT ID | NCT06656624 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University |
| Condition | Advanced Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 190 participants |
| Start Date | 2024-08-13 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 190 participants in total. It began in 2024-08-13 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To compare the efficacy and safety of ribociclib in combination with aromatase inhibitor and physician's choice of chemotherapy sequential endocrine therapy in the first-line treatment of ER medium to low expression/HER2-negative advanced breast cancer.
Eligibility Criteria
Inclusion Criteria: 1. Patient is an adult female ≥ 18 years old at the time of informed consent. 2. ECGO rating 0-2. 3. Histologically confirmed recurrent or metastatic breast cancer, including patients initially diagnosed as stage IV or locally advanced inoperable patients. 4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer based on the most recently analyzed tissue sample and all tested by local laboratory. ER should express in the range of 10% to 50%. ER positive by local laboratory testing. 5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1 + or 2 + If IHC is 2 +, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing and based on the most recently analyzed tissue sample. 6. Determination by the physician that the patient is in a rapid disease progression situation: * Symptomatic visceral metastases * Rapid progression of disease or impending visceral compromise. * Markedly symptomatic non visceral disease if the treating physician opt to give chemotherapy for rapid palliation of patients symptoms. 7. Patient hasn't received systemic anti-cancer therapy at the stage of recurrence/metastasis. 8. Patient must have at least one measurable lesion (according to RECIST 1.1 criteria) 9. Postmenopausal or pre/perimenopausal female patients are eligible for enrolment; pre or perimenopausal female patients must be willing to receive LHRHa during the study period. 10. All patients were required to meet the following laboratory biochemical values prior to enrolment: * Haematology: Hb ≥90 g/L, WBC ≥3.5×109/L, ANC ≥1.5×109/L, PLT ≥100×109/L; * Renal function: serum creatinine ≤ upper limit of normal value; * Liver function: for those without liver metastases, AST, ALT, ALP ≤2.5 times the upper limit of normal values, and ≤1.25 x the upper limit of normal values for total bilirubin; for those with liver metastases, AST, ALT, ALP ≤ 5 times the upper limit of normal value, and total bilirubin ≤ 1.5 x upper limit of normal value. Exclusion Criteria: 1. Patient has received systemic anti-cancer therapy at the stage of recurrence/metastasis. 2. Those who have been treated with CDK4/6 inhibitors in the neoadjuvant/adjuvant phase. 3. Patients those with symptomatic CNS metastases. 4. Patient has a history of clinically symptomatic cardiovascular, hepatic, respiratory, renal and haemato-endocrine system or neuropsychiatric disorders. 5. Patient has a serious concomitant disease, such as an infectious disease; has multiple factors that affect the oral administration and absorption of the drug. 6. Pregnant or lactating women (women of childbearing age must have had a negative pregnancy test within 14 days prior to the first dose; if positive, pregnancy must be ruled out by ultrasound). 7. Patients in poor general condition who cannot tolerate chemotherapy treatment. 8. The investigator considers the patient unsuitable for entry into this study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06656624 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Advanced Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06656624 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06656624 currently recruiting?
Yes, NCT06656624 is actively recruiting participants. Contact the research team at ymyin@njmu.edu.cn for enrollment information.
Where is the NCT06656624 trial being conducted?
This trial is being conducted at Nanjing, China.
Who is sponsoring the NCT06656624 clinical trial?
NCT06656624 is sponsored by The First Affiliated Hospital with Nanjing Medical University. The trial plans to enroll 190 participants.
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