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

Ying Lin

Status and phase: Enrolling; Phase 2

Conditions: Her-2 Negative Breast Cancer; HRR Gene Mutation

Treatments: Drug: Fluzoparib; Drug: Nab-paclitaxel; Drug: Camrelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05761470

20220430GD

Details and patient eligibility

About

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.

Full description

This is a prospective, single-center, open-label phase II clinical trial investigating the activity of Camrelizumab+Fluzoparib+Nab-paclitaxel combination therapy in breast cancer patients with Her2-negative and HRR gene mutation for neoadjuvant therapy.

Anticipated 66 candidates meeting all study eligibility criteria will receive 8 cycles of Nab-paclitaxel (260mg/m2) every 3 weeks, which will add Camrelizumab (200mg, d1) and Fluzoparib (100mg BID) from the second cycle.

HRR gene mutation contains 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.

Enrollment: 66 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Camrelizumab, Fluzoparib and Nab-paclitaxel

Experimental group

Description:

Participants who confirmed pathogenic or likely pathogenic HRR gene mutation received Camrelizumab and Fluzoparib with nab-paclitaxel from the second cycle followed by nab-paclitaxel for one cycle.

Treatment:

Drug: Fluzoparib

Drug: Camrelizumab

Drug: Nab-paclitaxel