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A Study of SH3765 Tablets in Combination With Fulvestrant in Patients With HR+/HER2- Advanced Breast Cancer.

NCT07557004 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-29

No results posted yet for this study

Summary

Evaluate the efficacy and safety of the SH3765 tablet combined with fulvestrant in the treatment of patients with advanced HR-positive breast cancer

Conditions

  • HR+ / HER2- Advanced Breast Cancer

Interventions

DRUG

SH3765+Fulvestrant

Drug1: SH3765 will be administered orally twice daily on an intermittent dosing schedule with treatment on Days 1 to 4 each week of a 28-day treatment cycle. The dosage is 40 mg or 60mg twice daily (BID) (4 days on and 3 days off). Drug2：Fulvestrant injection is to be administered after taking the SH3765 tablets. It is given intramuscularly at a dose of 500 mg on Day 1 and Day 15 of Cycle 1, and then on Day 1 of each subsequent 28-day cycle.

Sponsors & Collaborators

  • Nanjing Sanhome Pharmaceutical, Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT07557004 on ClinicalTrials.gov