Actively Recruiting
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
Led by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. · Updated on 2026-05-08
430
Participants Needed
2
Research Sites
289 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, any gender
- Confirmed hormone receptor-positive, HER2-negative breast cancer by biopsy or pathology
- Documented disease progression during or after the most recent treatment
- No prior systemic chemotherapy for locally advanced, relapsed, or metastatic breast cancer
- Previously received adjuvant or neoadjuvant chemotherapy allowed if progression occurred more than 6 months after last treatment
- Assessed by investigator as no longer benefiting from endocrine therapy and suitable for first-line chemotherapy
- Able to provide recent or archival tumor tissue samples
- At least one measurable lesion according to RECIST v1.1
- ECOG performance status of 0 to 1 without worsening in the two weeks before randomization
- Life expectancy of at least 12 weeks
- Suitable to receive one of the chemotherapy regimens listed (paclitaxel, nab-paclitaxel, capecitabine)
- Adequate organ and bone marrow function
- Recovered from all toxicities of prior treatments
- Use of effective contraception during treatment and for six months after for subjects of childbearing potential
- Willingness to participate, sign informed consent, and follow study visits and procedures
You will not qualify if you...
- Locally advanced breast cancer suitable for curative treatment at enrollment
- Other cancers within 3 years prior to randomization except certain cured tumors
- Known metastases to meninges, brainstem, spinal cord, or active central nervous system metastases
- Serious cardiovascular or cerebrovascular diseases or risk factors
- History of noninfectious interstitial lung disease or current lung disease requiring steroids
- Serious lung injury due to lung diseases
- Serious infection within 4 weeks prior or active infection needing systemic treatment within 2 weeks prior
- Severe dry eye syndrome, meibomian gland dysfunction, blepharitis, or severe corneal disorders
- History of severe gastrointestinal conditions within 6 months prior
- Active hepatitis B or C infection
- Positive HIV test or AIDS history; active syphilis infection
- Known allergy to SKB264 or chemotherapy drugs
- History of organ or stem cell transplantation
- Pregnant or breastfeeding women
- Prior treatment targeting TROP2 or topoisomerase I chemotherapeutics
- Recent live vaccines within 4 weeks prior or planned during treatment
- Recent major surgery, radiation, immunotherapy, investigational drugs, or certain other treatments within specified timeframes
- Rapid deterioration or significant performance status changes during screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Fifth Medical Center of the Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100039
Actively Recruiting
2
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
Y
Yina Diao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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