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

trialsTrialRecruiting

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

A phase 1/2 trial of Fulvestrant in advanced solid tumours, run by Qilu Pharmaceutical Co., Ltd., now recruiting.

Overview Connected4

Overview

Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients is a phase 1/2 interventional study registered as NCT07235176 by Qilu Pharmaceutical Co., Ltd., with 300 participants planned, started 2026-01-16 and due to reach its primary completion in 2028-11-02. Interventions recorded: QLS1304 tablet+Fulvestrant or QLC1401 and QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i.

Setting

A Phase Ib/II Clinical Study to Evaluate Safety, Preliminary Efficacy and PK Characteristic of QLS1304 Combined With Endocrine Therapy in ER+/HER2- Breast Cancer Patients

Phase

Phase 1/2

Sponsor

Qilu Pharmaceutical Co., Ltd.

Registry

Started

2026-01-16

Enrolled

300 enrolled

Connected

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cancers

Metastatic cancer (cancer that has spread)

technologies

Endocrine therapy (SERMs, AIs, SERDs)

drugs

ApprovedInjectable SERD

Fulvestrant · Faslodex

companies

Qilu Pharmaceutical

Evidence strength25/100 · Preliminary

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 1/2+8
300 enrolled+12
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT07235176

Data

JSON ·

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Cancers

Metastatic cancer (cancer that has spread)

Technologies

Endocrine therapy (SERMs, AIs, SERDs)

Products

Fulvestrant

Companies

Qilu Pharmaceutical

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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