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Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients

NCT07235176 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-05-22

No results posted yet for this study

Summary

This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast cancer patients. This study was divided into two stages: combo dose escalation and dose expansion.

Conditions

  • Advanced ER+/HER2- Breast Cancer

Interventions

DRUG

QLS1304 tablet+Fulvestrant or QLC1401

QLS1304 combined with endocrine therapy

DRUG

QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i

QLS1304 combined with endocrine therapy

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-16
Primary Completion
2028-11-02
Completion
2031-12-30

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 NCT07235176 on ClinicalTrials.gov