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

Sponsor

Fudan University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05806060

Collaborator

(none)

192

Enrollment

Location

Arms

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Triple-Negative Breast Cancer	Drug: VEGFR Drug: nab-paclitaxel Drug: Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

192 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2025

Anticipated Study Completion Date :

Feb 28, 2026

Arms and Interventions

Arm	Intervention/Treatment
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).	Drug: VEGFR VEGFR Other Names: BP102 Drug: nab-paclitaxel Nab paclitaxel
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).	Drug: nab-paclitaxel Nab paclitaxel
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).	Drug: VEGFR VEGFR Other Names: BP102 Drug: Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin 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).	Drug: Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin TPC

Outcome Measures

Primary Outcome Measures

PFS [Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years)]
time to progressive disease (according to RECIST1.1)

Secondary Outcome Measures

ORR [max 6 months]
The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)
DoR [max 6 months]
Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause.
DCR [max 6 months]
The percentage of subjects with CR+PR+SD and last more than 4 weeks in all of the participants with measurable lesions.
OS [approximately 3 years]
Time to death due to any cause

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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)
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

Exclusion Criteria:

Symptomatic, untreated, or actively progressing CNS metastases
Significant cardiovascular disease
Adverse reactions of Grade ≥1 that are still continuing due to previous treatments. Exceptions are those of hair loss or which researchers take it as exception
Active hepatitis B or hepatitis C
History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death
Pregnancy or breastfeeding, or intention of becoming pregnant during the study
History of gastrointestinal bleeding within 6 months or any serious bleeding events
Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this study
Long-term unhealing wound or incomplete healing of fracture
Urine protein ≥2+ and 24h urine protein quantitative > 1 g
Patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg)