Combination treatment for advanced triple-negative breast cancer
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.
This study is testing a new combination of treatments for people with advanced triple-negative breast cancer to see if it helps them feel better and works safely.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy, doxorubicin, cyclophosphamide |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Trial ID | NCT06771609 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of PD-L1 combined with metronomic chemotherapy (vinorelbine, cyclophosphamide, and capecitabine) with or without radiotherapy in patients with advanced triple-negative breast cancer. The study aims to determine the safety and efficacy of this combination treatment in patients who have received limited prior chemotherapy. Participants will be monitored for measurable lesions and overall response to the treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with metastatic triple-negative breast cancer who have received one or fewer lines of chemotherapy.
Not a fit: Patients who have received more than one line of chemotherapy for metastatic breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with advanced triple-negative breast cancer.
How similar studies have performed: Other studies have shown promise in using PD-L1 inhibitors in combination with chemotherapy for various cancers, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Subjects are eligible to be included in the study only if all of the following criteria apply: 1. Male or female who is 18 years of age or older on the day of signing the informed consent form. 2. 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." 3. Have received less than or equal to 1 line of chemotherapy for metastatic breast cancer; 4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 10 days before the start of study treatment; 5. 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; 6. 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. 7. Female subjects are not pregnant, not lactating, and agree to use necessary contraceptive measures. 8. Subjects are able to sign an informed consent form to participate in the study. 9. 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.
Where this trial is running
Beijing, Beijing Municipality and 1 other locations
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
- Cancer Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Fei Ma 马
- Email: drmafei@126.com
- Phone: 010-87788120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.