RecruitingPhase 3NCT06081959

Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer

A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy


Sponsor

Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

Enrollment

376 participants

Start Date

Oct 31, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new antibody-drug treatment called SKB264 in patients with hormone receptor-positive, HER2-negative breast cancer (HR+/HER2-) that has spread or returned and stopped responding to prior chemotherapy. SKB264 delivers a chemotherapy drug directly to cancer cells using a targeted antibody. **You may be eligible if...** - You are 18 to 75 years old - You have HR+/HER2- breast cancer confirmed by biopsy that has spread or returned - You have already tried and failed at least one prior chemotherapy regimen - You have at least one measurable tumor - Your overall health is good (ECOG 0-1) - Your organ function and blood counts are adequate **You may NOT be eligible if...** - Your cancer has spread to the brain - You have had another cancer within the last 3 years (except certain skin cancers) - You have active hepatitis B, hepatitis C, or HIV infection - You have had prior treatment with a TROP2-targeted drug or topoisomerase I inhibitor - You are pregnant or breastfeeding - You have a serious lung condition or history of lung inflammation (ILD) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSKB264

IV infusion on day 1 and Day 15 of each 28 day cycle

DRUGEribulin

1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle

DRUGCapecitabine

1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle

DRUGGemcitabine

1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle

DRUGVinorelbine

25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle


Locations(1)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06081959


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