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RecruitingNCT05761470IMPARPUpdated Mar 9, 2023

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

A Phase 2 interventional study of Camrelizumab and Fluzoparib in Her-2 Negative Breast Cancer and HRR Gene Mutation, sponsored by Ying Lin. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-09.

Sponsored by Ying Lin · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Registered 7 months after the study started (first participant enrolled May 2022, registered Dec 2022).
  • Started May 2022; still recruiting 4 years 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
66
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Her-2 Negative Breast Cancer
  • HRR Gene Mutation
03

In context

Lead sponsor

This is the only study on the registry with Ying Lin as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    Camrelizumab, Fluzoparib and Nab-paclitaxel

    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.

    Drug: Camrelizumab · Drug: Fluzoparib · Drug: Nab-paclitaxel

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

06

What researchers measure

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

  5. Safety of drugs

    Adverse effects of the candidates according to NCI-CTCAE 5.0

    Time frame: Up to 32 weeks

07

Study locations

1 of 1 sites recruiting
  • First Affiliated Hospital, Sun Yat-Sen University
    Guangzhou, Guangdong 510080, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started May 2022 (actual). Primary completion is estimated for Jun 2024, 25 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 24, 2022
First posted
Mar 9, 2023
StartActual
May 6, 2022
Primary completionEst.
Jun 30, 2024
CompletionEst.
Dec 31, 2028
Last update
Mar 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05761470
Lead sponsor
Ying Lin
Responsible party
Ying Lin (director of department, First Affiliated Hospital, Sun Yat-Sen University) — Sponsor-investigator
First posted
Mar 9, 2023
Start date
May 6, 2022
Primary completion
Jun 30, 2024 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Mar 9, 2023

Study contacts

Ying Lin, MD
Contact
linying3@mail.sysu.edu.cn
+8602087755766 ext. 8212
Xiaying Kuang, MD
Contact
kuangxy5@mail.sysu.edu.cn
+8602087755766 ext. 8212
Ying Lin, MD
study chair · Principal Investigator

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Camrelizumab · Fluzoparib · Albumin-Bound Paclitaxel

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