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

Her-2 Negative Breast Cancer Clinical Trial

— IMPARP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761470
• Other study ID #: 20220430GD
• Status: Recruiting
• Phase: Phase 2
• Start date: May 6, 2022
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2023
• Source: First Affiliated Hospital, Sun Yat-Sen University
• Contact: Ying Lin, MD
• Phone: +8602087755766
• Email: linying3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: December 31, 2028
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Her-2 Negative Breast Cancer

Intervention

Drug:
• Camrelizumab
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.
• Fluzoparib
Fluzoparib
• Nab-paclitaxel
Nab-paclitaxel

Locations

Country	Name	City	State
China	First Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Ying Lin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response (pCR)	Pathologic response will be assessed in the surgically resected cancer and lymph nodes after completion of all chemotherapy by the local pathologist as part of routine care. Pathologic complete response is defined as no invasive cancer in the resected breast tissue and lymph nodes (ypT0/Tis, ypN0).	Up to 32 weeks
Secondary	Objective Response Rate (ORR)	ORR is defined as percentage of participants with Complete Response and Partial Response	Up to 32 weeks
Secondary	Residual Cancer Burden (RCB)	Pathologilly assessed residual cancer burden according to MD Anderson protocol.	Up to 32 weeks
Secondary	Event-Free Survival (EFS)	EFS was defined as the time from the date of randomization to the date of events from any cause.	Up to 20 years
Secondary	Overall Survival (OS)	OS was defined as the time from the date of randomization to the date of death from any cause.	Up to 20 years
Secondary	Safety of drugs	Adverse effects of the candidates according to NCI-CTCAE 5.0	Up to 32 weeks