First-Line Ribociclib Plus Endocrine Therapy Versus Chemotherapy With or Without Subsequent Endocrine Therapy in Patients With Rapidly Progressive HR-Positive/HER2-Negative Advanced Breast Cancer

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT06375707
Phase
PHASE2
Status
Completed

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    Ribociclib is administered orally at a dose of 600 mg once daily on Days 1-21 of each 28-day treatment cycle. It is given in combination with investigator-selected endocrine therapy, including anastrozole, letrozole, exemestane, or fulvestrant. Premenopausal or perimenopausal patients also receive ovarian function suppression with goserelin when indicated. Treatment continues until disease progression, unacceptable toxicity, death, withdrawal of consent, or another protocol-defined reason for discontinuation. Dose interruption or reduction is permitted according to protocol-specified toxicity management criteria.

Study Details

This phase II study focuses on women with rapidly progressive hormone receptor-positive and HER2-negative advanced breast cancer, including patients with symptomatic visceral metastases, rapidly increasing tumor burden, impending organ dysfunction, or highly symptomatic non-visceral disease. These patients often require prompt and effective systemic treatment. The purpose of the study is to determine whether first-line ribociclib combined with endocrine therapy can provide effective and rapid tumor control compared with chemotherapy-based treatment. Women in the prospective study group receive ribociclib plus endocrine therapy, with ovarian function suppression when clinically indicated. Their outcomes are compared with data from patients previously treated at the same participating hospitals with combination chemotherapy, with or without subsequent endocrine maintenance therapy. The main outcome is the objective response rate, defined as the proportion of patients whose tumors shrink or disappear. Other outcomes include progression-free survival, overall survival, clinical benefit, time to response, treatment safety, and quality of life.

Key Dates

First listed
Apr 19, 2024
Start date
Jan 9, 2024
Status verified
Apr 2024
Primary completion
May 30, 2026
Completion
May 30, 2026

Study Design

Enrollment
74 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib combined with ET±OFS

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]

Related Studies