Combining Ribociclib with NSAI for Advanced Breast Cancer Treatment
Efficacy and Safety of Ribociclib in Combination With NSAI Versus Physician's Choice of Chemotherapy Sequential Endocrine Therapy in HR+/HER2- Advanced Breast Cancer: a Phase II Randomised Controlled Clinical Trial
This study is testing if combining Ribociclib with hormone therapy is better than the usual chemotherapy for people with advanced breast cancer that is hormone receptor positive and HER2 negative.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 144 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT06375707 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of Ribociclib in combination with non-steroidal aromatase inhibitors (NSAI) compared to physician's choice of sequential chemotherapy in patients with HR+/HER2- advanced breast cancer. The study aims to determine the effectiveness of first-line treatment using CDK4/6 inhibitors alongside initial endocrine therapy versus sequential endocrine therapy following chemotherapy. It plans to enroll 144 patients with rapidly progressive disease and utilizes a central randomization system for treatment allocation. Key factors for stratification include hormone receptor expression levels and the presence of liver or lung metastases.
Who should consider this trial
Good fit: Ideal candidates are adult females aged 18 and older with HR+/HER2- advanced breast cancer experiencing rapid disease progression.
Not a fit: Patients with HER2-positive breast cancer or those who do not have hormone receptor-positive tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more effective treatment option for patients with HR+/HER2- advanced breast cancer, potentially improving survival rates and quality of life.
How similar studies have performed: Other studies have shown promising results with CDK4/6 inhibitors in similar patient populations, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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 be more than 10% 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.
Where this trial is running
Nanjing, Jiangsu
- Jiangsu Provincial People's Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Yongmei Yin, Ph.D
- Email: ymyin@njmu.edu.cn
- Phone: 025-68307102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.