RecruitingPhase 3NCT06533384

PARPi or Capecitabine Combined With PD-1 Inhibitors as Adjuvant Therapy in High-risk TNBC

PARPi or Capecitabine Combined With PD-1 Inhibitors Was Selected Based on the Germline BRCA1/2 Mutation vs. PD-1 Inhibitors Alone as Adjuvant Therapy in High-risk Non-pCR TNBC

Sponsor

Guangdong Provincial People's Hospital

Enrollment

310 participants

Start Date

Aug 1, 2024

Study Type

INTERVENTIONAL

Conditions

Triple-Negative Breast Cancer

Summary

In TNBC patients who have completed neoadjuvant immunotherapy and local treatment, a 9-cycle regimen of PD-1 inhibitor adjuvant immunotherapy is currently considered the standard approach. Based on the classification according to their BRCA mutation status, patients with BRCA mutations choose the PD-1 inhibitor + PARPi regimen, while patients without BRCA mutations opt for the PD-1 inhibitor + capecitabine regimen. Compared to monotherapy with PD-1 inhibitors, these combination regimens may offer improved efficacy and acceptable tolerability. This study is designed as a prospective, randomized, controlled, open-label, single-center phase III trial aimed at assessing the efficacy and safety of selecting PARPi or capecitabine in combination with PD-1 inhibitors based on germline BRCA1/2 mutations as adjuvant therapy in high-risk TNBC patients who have achieved non-pCR after completion of neoadjuvant immunotherapy in conjunction with chemotherapy and local treatment.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests two different approaches as additional treatment (adjuvant therapy) after completing standard chemotherapy and surgery for triple-negative breast cancer (TNBC) — a type of breast cancer that is harder to treat because it does not respond to hormone therapies or HER2-targeted drugs. Participants who still have cancer remaining after chemotherapy are at higher risk of relapse. This trial compares a PARP inhibitor (olaparib or similar) or capecitabine (oral chemotherapy), each combined with a PD-1 immunotherapy drug, to see which combination works better. **You may be eligible if...** - You have been diagnosed with invasive triple-negative breast cancer (ER-negative, PR-negative, HER2-negative) - Your cancer was stage T1c-T4, N0-N2 (various stages from medium to larger tumors, possibly with lymph node involvement) - You have had neoadjuvant chemotherapy and surgery and did not achieve a complete response (residual disease remains) - Your blood counts and organ function are within required ranges **You may NOT be eligible if...** - Your cancer is HER2-positive - You have significant active autoimmune disease - You are pregnant or breastfeeding - Your blood counts or organ function do not meet the minimum required Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAs per the germline BRCA1/2 mutation status, the selection of either Fuzuloparib or capecitabine in combination with Camrelizumab is made for adjuvant therapy.

As per the germline BRCA1/2 mutation status, the selection of either Fuzuloparib or capecitabine in combination with Camrelizumab is made for adjuvant therapy.

DRUG9 cycles of Camrelizumab as adjuvant therapy.

9 cycles of Camrelizumab as adjuvant therapy.

Locations(1)

Department of Breast Cancer, Cancer Center, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University

Guangzhou, Guangdong, China

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NCT06533384

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