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Trials
A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy

trialsTrialRecruiting

A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy

A phase 3 trial of Capecitabine in advanced solid tumours, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., now recruiting.

Overview Connected4

Overview

A Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic HR+/HER2- Breast Cancer Who Have Previously Failed Endocrine Therapy is a phase 3 interventional study registered as NCT07071337 by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd., with 430 participants planned, started 2025-07-18 and due to reach its primary completion in 2027-07. Interventions recorded: SKB264, Nab-paclitaxel, Paclitaxel and Capecitabine.

Setting

A Randomized, Open-label, Multicenter Phase III Clinical Study of SKB264 Versus Investigator's Choice of Chemotherapy in Subjects With Unresectable Locally Advanced, Relapsed, or Metastatic Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2-negative (HER2-) Breast Cancer Who Have Previously Failed Endocrine Therapy

Phase

Phase 3

Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Registry

Started

2025-07-18

Enrolled

430 enrolled

Connected

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Shares Capecitabine, Metastatic cancer (cancer that has spread), Cytotoxic chemotherapy and the tag pipeline.

cancers

Metastatic cancer (cancer that has spread)

technologies

Cytotoxic chemotherapy

drugs

ApprovedOral fluoropyrimidine prodrug (antimetabolite)

Capecitabine · Xeloda

companies

Sichuan Kelun-Biotech

Evidence strength48/100 · Emerging

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

Phase 3+30
430 enrolled+13
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 NCT07071337

Data

JSON ·

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Cancers

Metastatic cancer (cancer that has spread)

Technologies

Cytotoxic chemotherapy

Products

Capecitabine

Companies

Sichuan Kelun-Biotech

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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