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

ConditionsHer-2 Negative Breast CancerHRR Gene Mutation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorYing Lin

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Camrelizumab

    Drug

    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

    Drug

    Fluzoparib

  • Nab-paclitaxel

    Drug

    Nab-paclitaxel

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: Camrelizumab, Fluzoparib and Nab-paclitaxelExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
Up to 32 weeks

Secondary outcomes

1

Objective Response Rate (ORR)

ORR is defined as percentage of participants with Complete Response and Partial Response

Time frame
Up to 32 weeks
2

Residual Cancer Burden (RCB)

Pathologilly assessed residual cancer burden according to MD Anderson protocol.

Time frame
Up to 32 weeks
3

Event-Free Survival (EFS)

EFS was defined as the time from the date of randomization to the date of events from any cause.

Time frame
Up to 20 years
4

Overall Survival (OS)

OS was defined as the time from the date of randomization to the date of death from any cause.

Time frame
Up to 20 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ying Lin

Lead sponsor

First Affiliated Hospital, Sun Yat-Sen University

Sponsor institution

Source ClinicalTrials.gov
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