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Tests treatment safety and results for Metastatic Breast Cancer
Official title Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT05816655
What this study is testing
What is Fulvestrant plus AI plus ribociclib?
Fulvestrant plus AI plus ribociclib is an investigational medicine, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Aromatase inhibitor (AI) + CDK4/6 inhibitor is settled down as the standard first line therapy for HR+/HER2- metastatic breast cancer and all three CDk4/6 inhibitors, palbociclib, ribociclib, and abemaciclib are currently available for same indications. However, there is no effective treatment strategy for patients who have progressed on AI+CDK4/6 inhibitor.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 80, women only
You may be able to join if
- 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...
- ECOG PS 0-2
You likely can't join if
- 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...
- 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...
- Patients having visceral crisis which needs rapid tumor reduction
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.