Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07869628
PHASE3

A Multicenter, Randomized, Controlled Phase III Clinical Trial on Adjuvant Intensified Therapy for Patients With Residual Disease After Neoadjuvant Treatment for Triple-negative Breast Cancer

Sponsor: Shandong Cancer Hospital and Institute

View on ClinicalTrials.gov

Summary

This study is a multicenter, randomized controlled phase III clinical trial. The aim of this study is to observe the efficacy and safety of PD-1 inhibitors combined with capecitabine, PD-1 inhibitors alone, or capecitabine alone in patients with TNBC who have residual lesions after neoadjuvant treatment. The subjects will be randomly assigned in a 1:1:1 ratio to Group A (capecitabine combined with PD-1 inhibitor), Group B (PD-1 inhibitor), and Group C (capecitabine). The stratification factors are the lymph node metastasis status (lymph node metastasis negative ypN0, lymph node metastasis positive ypN1-3) and PD-L1 status (negative/positive) after neoadjuvant treatment. Group A: Capecitabine, 1250mg/m2, twice a day, 14/21 days, combined with PD-1 inhibitor, for a total of 8 cycles Group B: PD-1 inhibitor, for a total of 8 cycles Group C: Capecitabine, 1250mg/m2, twice a day, 14/21 days, for a total of 8 cycles The study will include approximately 10 centers. After the completion of NAT (chemotherapy + immunotherapy), 852 patients with residual lesions (breast still has invasive cancer lesions remaining and/or positive axillary lymph nodes) will be enrolled, with 284 patients in each of Groups A, B, and C. After surgery, clinicians will, based on clinical treatment guidelines and the clinical practices of each center, administer radiotherapy to subjects with indications for radiotherapy. During radiotherapy, the use of capecitabine and/or immunotherapy is decided by the supervising doctor as either concurrent or sequential.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

852

Start Date

2026-10-17

Completion Date

2034-08-31

Last Updated

2026-10-09

Healthy Volunteers

No

Interventions

DRUG

Capecitabine and PD-1 inhibitor

Group A: Capecitabine, 1250mg/m\^2, twice a day, 14/21 days, combined with PD-1 inhibitor, for a total of 8 cycles

DRUG

PD-1 inhibitor

Group B:PD-1 inhibitor, 8 treatment cycles in total

DRUG

Capecitabine

Group C:Capecitabine, 1250mg/m\^2, twice a day, 14/21 days, a total of 8 cycles