Precise Treatment for BLIS Subtype of Triple-negative Breast Cancer in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The study is being conducted to evaluate VEGFR BP102 with nab-paclitaxe or treatment of physician's choice (TPC) versus nab-paclitaxe or TPC in patients for basal-like immune suppressed (BLIS) subtype of triple-negative breast cancer (TNBC) in the first-line teatment of unresectable locally advanced or metastatic TNBC.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• ECOG Performance Status of 0-1

• Expected lifetime of not less than three months

• Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) with BLIS subtype

• Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection

• Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer

• At least one measurable or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), which didn't receive radiation therapy

• The functions of major organs are basically normal

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm

• Have the cognitive ability to understand the protocol and be willing to participate and to be followed up

Locations
Other Locations
China
Breast cancer institute of Fudan University Cancer Hospital
RECRUITING
Shanghai
Contact Information
Primary
Zhimin Shao
zhimingshao@yahoo.com
86-021-64175590
Time Frame
Start Date: 2023-04-25
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 192
Treatments
Experimental: De novo or DFI≥12m Arm 1
If patients were De novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to experimental arm, they would receive VEGFR BP102 with nab-palitaxel (Nab-P). And maintained by VEGFR and capecitabine if intolerable toxicity was observed with no progression.
Active_comparator: De novo or DFI≥12m Arm 2
If patients were De novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to control arm, they would receive nab-palitaxel (Nab-P). And maintained by capecitabine if intolerable toxicity was observed with no progression.
Experimental: DFI<12m Arm 1
If patients' disease-free interval (DFI) were less than 12 months and were randomized to experimental arm, they would receive VEGFR BP102 with treatment of physician's choice (TPC).
Active_comparator: DFI<12m Arm 2
If patients' disease-free interval (DFI) were less than 12 months and were randomized to control arm, they would receive physician's choice (TPC).
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov

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