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

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.

Trial Details

NCT ID

NCT07235176

Phase

PHASE1 / PHASE2

Sponsor

Qilu Pharmaceutical Co., Ltd.

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

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

Locations (sample)

Shanghai, China|31.22222,121.45806

Key Eligibility Criteria

Volunteer to participate in this study, sign an informed consent form and have good compliance;
Age ≥ 18 years old, Male or female
ECOG score: 0-1
Expected survival ≥ 12 weeks

For full eligibility, visit ClinicalTrials.gov.

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