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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.

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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06771609
Enrollment
150
Registered
2025-01-13
Start date
2024-09-10
Completion date
2028-09-10
Last updated
2026-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Triple-negative Breast Cancer

Keywords

advanced triple-negative breast cancer, PD-L1 in combination with VEX metronomic chemotherapy, radiotherapy

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.

Interventions

DRUGAdebrelimab + VEX metronomic chemotherapy + radiotherapy

1、Adebrelimab: 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

DRUGAdebrelimab + VEX metronomic chemotherapy

1、Adebrelimab: 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

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Progression-Free Survival24 monthsAccording 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).

Countries

China

Contacts

CONTACTFei Ma 马
drmafei@126.com010-87788120

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 11, 2026