Combination therapy for 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
This study is testing a new combination of three drugs to see if it helps people with early-stage HER2-negative breast cancer and specific gene mutations feel better before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital, Sun Yat-Sen University Academic / other |
| Drugs / interventions | Camrelizumab, Immunotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05761470 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of a combination therapy involving Camrelizumab, Fluzoparib, and Nab-paclitaxel for neoadjuvant treatment in patients with Her-2 negative breast cancer and HRR gene mutations. The study is a prospective, single-center, open-label phase II trial that aims to enroll 66 eligible candidates. Participants will receive 8 cycles of Nab-paclitaxel, with the addition of Camrelizumab and Fluzoparib starting from the second cycle. The focus is on patients with specific pathogenic mutations in genes related to homologous recombination repair.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically documented Her-2 negative breast cancer and specific HRR gene mutations.
Not a fit: Patients who are pregnant, have other malignancies, or serious cardiac diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve outcomes for patients with early-stage breast cancer who have HRR gene mutations.
How similar studies have performed: Other studies have shown promise with similar combination therapies in treating breast cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically documented Her-2 negative * TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3 * No distant metastatic disease * Eastern Cooperative Oncology Group Performance Status: 0\~1 * HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes. Exclusion Criteria: * Patients who are pregnant or lactating at the time of randomization or refuse to contraception. * Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ * Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study. * Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease. * Patients who have used immunosuppressive drug or corticosteroids within 14 days. * Patients who have other diseases which researchers. * Patients who allergy to any of the drugs in this trail.
Where this trial is running
Guangzhou, Guangdong
- First Affiliated Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Ying Lin, MD
- Email: linying3@mail.sysu.edu.cn
- Phone: +8602087755766
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.