JYP0035 Capsules Plus Fulvestrant in PIK3CA-Mutant HR+/HER2- Advanced Breast Cancer

Sponsor
Chengdu JOYO pharma Co., Ltd.
Study ID
NCT07784036
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • JYP0035 plus Fulvestrant — DRUG
    JYP0035 capsules 100 mg administered orally twice daily (BID). Fulvestrant 500 mg administered intramuscularly on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then on Day 1 of each subsequent 28-day cycle. One cycle is defined as 4 weeks (28 days).
  • JYP0035 placebo plus Fulvestrant — DRUG
    JYP0035 placebo 100 mg administered orally twice daily (BID). Fulvestrant 500 mg administered intramuscularly on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 15 (C1D15), then on Day 1 of each subsequent 28-day cycle. One cycle is defined as 4 weeks (28 days).

Study Details

This is a Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of JYP0035 Capsules in Combination With Fulvestrant in Patients With PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer Who Have Progressed on Prior Endocrine Therapy

Key Dates

First listed
Aug 25, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
Nov 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
171 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: JYP0035 plus Fulvestrant
  • Active Comparator: Placebo plus Fulvestrant

Primary Outcome Measure

Progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 [ Time Frame: Tumor imaging assessments will be performed every 8 weeks (±7 days) starting from Cycle 1 Day 1 (C1D1), and every 12 weeks (±7 days) after Week 48, until radiologic disease progression, initiation of new anti-cancer t(e.g., up to approximately 24 months) ]

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