Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer (BCTOP-T-M01)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Triple-Negative Breast Cancer
• Intervention / Treatment: Drug: VEGFR and TPC; Drug: TPC

• Study Type: Interventional
• Enrollment (Estimated): 134
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zhimin Shao; Phone Number: 8888 86-021-64175590; Email: zhimingshao@yahoo.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Breast cancer institute of Fudan University Cancer Hospital
      • Sub-Investigator: Ying Zhou
      • Contact: Zhi-Ming Shao, MD; Phone Number: 86-21-641755901105; Email: zhimingshao@yahoo.com
      • Contact: Lei Fan, MD; Phone Number: 86-21-641755901105; Email: cmchen@medmail.com.cn
      • Principal Investigator: Zhi-Ming Shao, MD
      • Sub-Investigator: Min He, MD
      • Sub-Investigator: Linxiaoxi Ma, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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) 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

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
• Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access)
• Pregnancy or breastfeeding, or intention of becoming pregnant during the study
• Other malignancies within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma
• Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect the use and absorption of drugs
• Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites)
• Participated in clinical trials of other antitumor drugs within 4 weeks before first taking the investigational drug
• Long-term unhealing wound or incomplete healing of fracture
• Patients with known active HBV or HCV infection or hepatitis B DNA≥500, or chronic phase with abnormal liver function
• Allergic constitution, or known allergic history of the drug components of this trial; Or allergic to other monoclonal antibodies
• Patients with a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), were not allowed to enter the group; If there is occult blood in the stool (+), gastroscopy is required
• Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this trial
• Urine protein ≥2+ and 24h urine protein quantitative > 1.0 g
• Patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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. If patients' 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 and TPC; VEGFR and TPC 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: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks. If patients' DFI were less than 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt, every 4 weeks, + TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).; Other Names: Bevacizumab (BP102)
Active Comparator: 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. 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: TPC; 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: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks. If patients' DFI were less than 12 months and were randomized to control arm: TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	time to progressive disease (according to RECIST1.1)	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)	max 6 months
DoR	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.	max 6 months
DCR	The percentage of subjects with CR+PR+SD and last more than 4 weeks in all of the participants with measurable lesions.	max 6 months
OS	Time to death due to any cause	approximately 3 years
Safety and tolerability	Adverse events according to NCI-CTCAE Version 5.0 per each treatment arm	Approximately 3 years
Score of patient reported outcome (PRO)	Score of questionnaire by a report directly from a patient about his or her health or life quality.	Approximately 3 years
Exploratory biomarkers	The collected subjects' tumor tissues, paracancerous tissues, blood, and fecal samples will be used for discovering exploratory biomarkers.	Approximately 3 years

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: March 9, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Skin and Connective Tissue Diseases; Triple Negative Breast Neoplasms; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Bevacizumab; CCDC6 protein, human
• Other Study ID Numbers: FUSCC-TNBC-BLIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No