Evaluate the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined with VEX Metronomic Chemotherapy with or Without Radiotherapy in Advanced Triple-negative Breast Cancer: a Prospective, Multicenter, Randomized Controlled Phase II Clinical Trial.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Subjects are eligible to be included in the study only if all of the following criteria apply:

• Male or female who is 18 years of age or older on the day of signing the informed consent form.

• Subjects with metastatic triple-negative breast cancer, with clear clinical data records; specific reference to the American Society of Clinical Oncology - College of American Pathologists (ASCO/CAP) guidelines.

• Have received less than or equal to 1 line of chemotherapy for metastatic breast cancer;

• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 10 days before the start of study treatment;

• Subjects must have at least one measurable lesion present; specific reference to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) guidelines;

• Subjects may have previously received treatment with anthracyclines (e.g., doxorubicin, epirubicin) and/or taxanes (e.g., paclitaxel, docetaxel) as follows: a) The subject has used anthracyclines and/or taxanes during adjuvant and/or neoadjuvant therapy before breast cancer recurrence. b) The subject has experienced treatment failure during or after chemotherapy based on anthracyclines and/or taxanes. c) According to the investigator's judgment, the Subject is not suitable for anthracyclines and/or taxanes-based chemotherapy as a first-line treatment option.

• Female subjects are not pregnant, not lactating, and agree to use necessary contraceptive measures.

• Subjects are able to sign an informed consent form to participate in the study.

• Have appropriate organ function, as detailed in Table 1; all screening laboratory tests should be completed within 10 days before the start of study treatment.

Locations
Other Locations
China
Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Cancer Hospital, Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Fei Ma 马
drmafei@126.com
010-87788120
Time Frame
Start Date: 2024-09-10
Estimated Completion Date: 2028-09-10
Participants
Target number of participants: 150
Treatments
Experimental: 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).
Active_comparator: 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
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov