Phase II Clinical Trial of PD-L1 in Combination with Vinorelbine + Cyclophosphamide + Capecitabine (VEX) Metronomic Chemotherapy with or Without Radiotherapy for Advanced Triple-negative Breast Cancer.

Phase 2

Recruiting

• Conditions: Advanced Triple-negative Breast Cancer
• Interventions: Drug: Adebry single antibody + VEX metronomic chemotherapy + radiotherapy; Drug: debry single antibody + VEX metronomic chemotherapy

• Registration Number: NCT06771609
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

Phase II clinical trial of PD-L1 in combination with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy with or without radiotherapy for advanced triple-negative breast cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-10
• Study First Submitted: 2024-12-10
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-13
• Last Update Posted: 2025-01-13
• Primary Completion: 2028-09-10
• Study Completion: 2028-09-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Adebry single antibody + VEX metronomic chemotherapy + radiotherapy	Adebry single antibody + VEX metronomic chemotherapy + radiotherapy	1. Adebry antibody: 1200mg on day 1, every 3 weeks； 2. vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W 3. Radiotherapy: Radiotherapy is administered within 3 weeks after the first immunotherapy. Different radiotherapy techniques are chosen based on the size and location of the metastatic lesions: Stereotactic Body Radiation Therapy (SBRT), Spatially Fractionated Radiation Therapy (SFRT), or Low-dose Radiotherapy (LDRT).
debry single antibody + VEX metronomic chemotherapy	debry single antibody + VEX metronomic chemotherapy	1. Adebry antibody: 1200mg on day 1, every 3 weeks； 2. VEX Metronomic Chemotherapy: Vinorelbine 20mg orally, once every other day, Q3W Cyclophosphamide 50mg orally, once daily, Q3W Capecitabine 500mg orally, three times daily, Q3W

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	24 months	According to RECIST 1.1 criteria：Disease Progression (PD): Referring to the smallest sum of the diameters of all measured target lesions throughout the entire experimental study, there is a relative increase of at least 20% in the sum of the diameters (if the baseline measurement is the smallest, then the baseline value is used as the reference); in addition, there must be an absolute increase of at least 5 mm in the sum of the diameters (the appearance of one or more new lesions is also considered disease progression).

Trial Locations

Locations (1)

Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China