Comparing two treatment combinations for hormone receptor positive metastatic breast cancer
Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer - a Randomized, Phase 2 Study
This study is testing two different treatment combinations to see which one works better for women with hormone receptor positive metastatic breast cancer that hasn't responded to previous treatments.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 202 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | Female |
| Sponsor | Korea University Guro Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Seoul and 1 other locations) |
| Trial ID | NCT05816655 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of two treatment regimens for patients with hormone receptor positive, HER2 negative metastatic breast cancer. One group will receive a combination of fulvestrant, an aromatase inhibitor, and ribociclib, while the other group will receive only the aromatase inhibitor and ribociclib. The study aims to determine which treatment approach is more effective in patients who have progressed on previous therapies. The trial will include female participants aged 19 and older with specific eligibility criteria related to their cancer history and health status.
Who should consider this trial
Good fit: Ideal candidates are females aged 19 and older with hormone receptor positive, HER2 negative metastatic breast cancer who have not received prior systemic treatment for advanced disease.
Not a fit: Patients with a history of systemic endocrine or chemotherapy for metastatic breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients who have not responded to standard therapies.
How similar studies have performed: Previous studies have shown promising results with similar treatment strategies, particularly in delaying resistance to hormone therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female ≥ 19 years of age * Histologically confirmed unresectable, locally advanced or metastatic invasive breast cancer with hormone receptor positive/HER2 negative * No previous history of systemic endocrine or chemotherapy for metastatic, advanced breast cancer. * If the patient has received AI as adjuvant endocrine therapy, the treatment free interval (TFI) should be more than 12 months after the end of adjuvant endocrine therapy. If the patient has received tamoxifen for adjuvant endocrine therapy, TFI less than 12 months will be allowed. * ECOG PS 0-2 * Patients should have measurable or evaluable lesion based on RECIST version 1.1 * Patients should have adequate organ function: * ANC (absolute neutrophil count) ≥ 1.5 × 109/L * Platelet ≥ 100 × 109/L * Serum Hb ≥ 9.0 g/dL * INR ≤1.5 * Serum creatinine ≤ 1.5 X ULN * ALT \& ALT \<2.5 X ULN, if patients have hepatic metastasis, ALT \& ALT \<5.0 X ULN is allowed * Total serum bilirubin \<1.5 X ULN, if patients have hepatic metastasis, Total serum bilirubin \<3.0 X ULN is allowed. * In the case of childbearing potential, patients who can adhere to appropriate contraception during the study period and for at least 6 months after the end of study treatment. * Patients who understand the contents of the clinical trial and are cooperative with the process of the clinical trial. Exclusion Criteria: * Patients with a history of previous treatment with a CDK4/6 inhibitor or other systemic treatment for advanced/metastatic breast cancer * Patients who have received prior treatment with fulvestrant and any investigational ER-directed therapy including SERDs (selective estrogen receptor degrader) * Patients who have disease recurrence on aromatase inhibitor treatment as adjuvant endocrine therapy * Patients who have symptomatic or untreated central nervous system metastasis * Patients who have a history of cardiovascular disease or heart failure as following conditions; within at least 6 months of myocardial infarction, unstable angina, or uncontrolled arrhythmia. * Patients having visceral crisis which needs rapid tumor reduction * Patients who have a history of any other cancer (except nonmelanoma skin cancer, carcinoma in-situ of the cervix, well-differentiated thyroid cancer) * Patients unable to cooperate with periodic blood samples collection * Patients who have active HBV, HCV infection, immune-suppressive disease, or HIV infection. In case of chronic HBV infection, HBV DNA should be negative. Patients with complete remission of HCV infection are allowed. * Pregnant or breast-feeding women * Patients who are considered to be unsuitable for this trial by investigators.
Where this trial is running
Seoul and 1 other locations
- Korea university Guro hospital — Seoul, South Korea (Recruiting)
- St Mary Hospital — Seoul, South Korea (Recruiting)
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.