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Trials
A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)

trialsTrialRecruiting

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)

A phase 3 trial of Capecitabine in advanced solid tumours, run by Sichuan Baili Pharmaceutical Co., Ltd., now recruiting.

Also called: PANKU-Breast03

Overview Connected4

Overview

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03) is a phase 3 interventional study registered as NCT07648914 by Sichuan Baili Pharmaceutical Co., Ltd., with 446 participants planned, started 2026-07-06 and due to reach its primary completion in 2028-12. Interventions recorded: BL-B01D1, Albumin-Bound Paclitaxel, Paclitaxel and Capecitabine.

Setting

A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)

Phase

Phase 3

Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Registry

Started

2026-07-06

Enrolled

446 enrolled

Connected

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A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer(PANKU-Breast01)
Shares SystImmune / Sichuan Biokin, Capecitabine, Metastatic cancer (cancer that has spread) and the tag pipeline.

cancers

Metastatic cancer (cancer that has spread)

technologies

Cytotoxic chemotherapy

drugs

ApprovedOral fluoropyrimidine prodrug (antimetabolite)

Capecitabine · Xeloda

companies

SystImmune / Sichuan Biokin

Evidence strength48/100 · Emerging

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

Phase 3+30
446 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 NCT07648914

Data

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Cancers

Metastatic cancer (cancer that has spread)

Technologies

Cytotoxic chemotherapy

Products

Capecitabine

Companies

SystImmune / Sichuan Biokin

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