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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 who have previously failed endocrine therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Aged ≥ 18 and ≤ 75 years at the time of signing the ICF, male or female;

• Histologically and/or cytologically confirmed HR+/HER2- BC based on pathological reports from the most recent biopsy or other pathological specimens;

• Subjects must have radiologically documented disease progression during or after the most recent treatment prior to enrollment;

• No prior systemic chemotherapy for locally advanced, relapsed, or metastatic stages. Subjects who previously received adjuvant/neoadjuvant chemotherapy and progressed \>6 months after completion of the last chemotherapy treatment will be allowed for study inclusion;

• The investigator assessed that the patient could not continue to benefit from endocrine therapy and was suitable for receiving first-line chemotherapy;

• Able to provide recently newly obtained or archival tumor tissue sections at or after diagnosis of relapsed or metastatic tumor within the recent prior to randomization;

• At least one measurable lesion per RECIST v1.1;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization;

• Life expectancy of ≥ 12 weeks;

⁃ Suitable to receive one of the chemotherapy regimens listed in the investigator's choice of chemotherapy (paclitaxel, nab-paclitaxel, capecitabine) as assessed by the investigator;

⁃ Adequate organ and bone marrow function;

⁃ Having recovered from all toxicities due to prior treatment;

⁃ Use of effective medical contraception during study treatment and for 6 months after the end of dosing for female subjects of childbearing potential and male subjects with partners of childbearing potential;

⁃ Willingness to participate in the study, sign the ICF, and comply with the protocol-specified visits and relevant procedures.

Locations
Other Locations
China
The Fifth Medical Center of the Chinese PLA General Hospital
RECRUITING
Beijing
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Yina Diao
diaoyina@kelun.com
86-028-67252634
Time Frame
Start Date: 2025-07-18
Estimated Completion Date: 2031-02
Participants
Target number of participants: 430
Treatments
Experimental: SKB264
Active_comparator: Investigator's Choice of Chemotherapy
Nab-paclitaxel, paclitaxel or capecitabine will be administered and managed according to the investigator's clinical judgment, guided by clinical practice.
Sponsors
Leads: Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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