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

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Triple-Negative Breast Cancer

Treatments: Drug: nab-paclitaxel, with maintenance of capecitabine; Drug: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine; Drug: VEGFR and TPC; Drug: Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1

Study type: Interventional

Funder types: Other

Identifiers

NCT05806060

FUSCC-TNBC-BLIS

Details and patient eligibility

About

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.

Enrollment: 192 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No 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) 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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192 participants in 4 patient groups

De novo or DFI≥12m Arm 1

Experimental group

Description:

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.

Treatment:

Drug: VEGFR and nab-paclitaxel, with maintenance of VEGFR and capecitabine

De novo or DFI≥12m Arm 2

Active Comparator group

Description:

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.

Treatment:

Drug: nab-paclitaxel, with maintenance of capecitabine

DFI<12m Arm 1

Experimental group

Description:

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).

Treatment:

Drug: VEGFR and TPC

DFI<12m Arm 2

Active Comparator group

Description:

If patients' disease-free interval (DFI) were less than 12 months and were randomized to control arm, they would receive physician's choice (TPC).

Treatment:

Drug: Eribulin Mesylate/Vinorelbine/Capecitabine/Carboplatin/UTD1