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

NCT07784036 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 171

Last updated 2026-08-25

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

JYP0035 plus Fulvestrant

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).

DRUG

JYP0035 placebo plus Fulvestrant

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).

Sponsors & Collaborators

  • Chengdu JOYO pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-11-30
Completion
2029-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784036 on ClinicalTrials.gov