RecruitingPhase 2NCT05761470

Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation

A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation


Sponsor

Ying Lin

Enrollment

66 participants

Start Date

May 6, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of three treatments before surgery — camrelizumab (immunotherapy), fluzoparib (a PARP inhibitor), and nab-paclitaxel (chemotherapy) — in people with early-stage breast cancer that carries mutations in DNA repair genes (called HRR genes). These mutations may make the cancer more responsive to PARP inhibitors. **You may be eligible if...** - You have HER2-negative early-stage breast cancer (specific stages T1c N1-2, T2-4 N0-2, or any T with N3) - Your cancer carries a mutation in BRCA1, BRCA2, PALB2, ATM, or other HRR genes - You have not received prior breast cancer treatment - Your general health is good (ECOG 0–1) and cancer has not spread to distant organs **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have had another cancer in the past 2 years - You have autoimmune disease requiring treatment or a history of serious immune-related complications - You have significant heart problems 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

DRUGCamrelizumab

Camrelizumab at a fixed dose of 200mg via IV infusion on Days 1 each 21-day cycle. Fluzoparibat at a fixed dose of 100mg BID, each 21-day cycle. Nab-paclitaxel at a fixed dose of 260 milligrams via intravenous (IV) infusion on Days 1 each 21-day cycle.

DRUGFluzoparib

Fluzoparib

DRUGNab-paclitaxel

Nab-paclitaxel


Locations(1)

First Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT05761470


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