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

Recruiting Phase 3 Interventional Study
Metastatic Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
430 (estimated)
Sponsor
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Industry
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About This Trial

The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who have previously failed endocrine therapy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Aged ≥ 18 and ≤ 75 years at the time of signing the ICF, male or female; 2. Histologically and/or cytologically confirmed HR+/HER2- BC based on pathological reports from the most recent biopsy or other pathological specimens; 3. Subjects must have radiologically documented di…
Contacts

Yina Diao

86-028-67252634

diaoyina@kelun.com

CONTACT