NCT05816655RecruitingPhase 2
Comparison of Clinical Efficacy Between Letrozole + Ribociclib and Fulvestrant + Letrozole + Ribociclib in Hormone Receptor Positive, HER2 Negative 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
Source: ClinicalTrials.gov · Last updated 18 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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. In particular, the clinical efficacies of subsequent hormone therapy are lowered when ESR1 mutations, one of mechanisms of AI resistance occur. In the PADA-1 trial, when ESR1 mutations in ctDNA were detected in patients treated with AI+CDK4/6 inhibitor, AI was switched to fulvestrant even if disease progression was not confirmed clinically. As a result, the median PFS was prolonged by about 8 months in this switching group compared to the group in which AI was continued. The results of this study suggested that delaying the occurrence of ESR1 mutations and early response to them are necessary to increase the effectiveness of hormone therapy. In SWOG S0226 study, fulvestrant + AI combination showed significant benefits in PFS and OS compared to AI monotherapy as the first line therapy. Based on these results, the NCCN guideline suggests fulvestrant + AI combination as one of the first line hormone therapy options. However, the clinical effect of AI + fulvestrant + CDK4/6 inhibitor has not been investigated yet. Therefore, the investigators are planning to compare the clinical efficacy of AI+ fulvestrant + CDK4/6 inhibitor and AI+CDK4/6 inhibitor, and to investigate if a triple combination regimen can delay the emergence of ESR1 mutations and modulate occurred ESR1 mutations.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 202 (estimated)
- First submitted
- 22 Mar 2023
- Start date
- 31 May 2023
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Korea University Guro Hospital
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05816655
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 202
- From 31 May 2023 to the primary completion date, 31 Dec 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- Patients who have disease recurrence on aromatase inhibitor treatment as adjuvant endocrine therapy
- 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 who have a history of any other cancer (except nonmelanoma skin cancer, carcinoma in-situ of the cervix, well-differentiated thyroid cancer)
- 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.
Other
- Patients who have symptomatic or untreated central nervous system metastasis
- Patients having visceral crisis which needs rapid tumor reduction
- Patients unable to cooperate with periodic blood samples collection
- Pregnant or breast-feeding women
- Patients who are considered to be unsuitable for this trial by investigators.
Who the study is looking for
- 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.
Age in the registry: 19 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| St Mary Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.