Germline BRCA-mutated HER2-negative Breast CancerPhase 2NCT05576389
Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study
A Phase 2 study testing Camrelizumab+Fluzoparib in people with Germline BRCA-mutated HER2-negative Breast Cancer, run by Peking University People's Hospital at 1 site in China.
Trial summary
This study is an open-label, single-arm, multicenter clinical study. 64 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Germline BRCA-mutated HER2-negative Breast Cancer
- What is being tested?
- Camrelizumab+Fluzoparib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 31 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the definition of the latest ASCO/CAP guidelines, early or locally advanced HER2 negative invasive breast cancer confirmed by histopathology meets the following conditions:
- HER2 negative: IHC 0/1+or IHC2+with no amplification of ISH;
- Primary tumor size: ≥ 1cm
- Lymph node status: N0-3
- Inflammatory breast cancer patients with measurable lesions (according to RECIST 1.1 standard)
- Patients with bilateral breast cancer whose primary lesions all meet the inclusion criteria, or breast cancer with Tis-1bN0 and HER2 negative on the other side only meeting the inclusion criteria on one side;
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- The hormone receptor status is known;
- ECOG score 0-1;
- Carrying BRCA1 or BRCA2 germline pathogenic mutations or suspected pathogenic mutations;
- According to RECIST 1.1 standard, at least one measurable lesion is present;
Who cannot join
- Tumor related symptoms and treatment
- Recurrent or metastatic breast cancer;
- Participated in other drug trials or received any anti-tumor therapy, including endocrine therapy, bisphosphate therapy, immunotherapy, biological therapy, or tumor embolization, within 4 weeks prior to enrollment;
- Previously received treatment for PD-1/PD-L1 antibodies, CTLA-4 antibodies, or other PD-1/PD-L1 inhibitors;
- Previously received PARP inhibitor treatment (excluding those who have completed PARP inhibitor treatment for ovarian cancer for at least 5 years without recurrence or metastasis);
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis or combined hepatitis B and C co-infection; autoimmune hepatitis;
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- Confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia; angina requiring antianginal medication
- Female patients who are pregnant or lactating
- History of definite neurological or psychiatric disorders, including epilepsy or dementia
- Presence of interstitial lung disease, pneumonitis, or uncontrolled systemic disease (eg, diabetes mellitus, pulmonary fibrosis, acute pneumonitis, etc.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Breast Cancer, Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Shu Wang, Dr., 13801080201, shuwang@pkuph.edu.cn
About this study
This study is an open-label, single-arm, multicenter clinical study. 64 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。
- Being tested
- Camrelizumab+Fluzoparib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab+FluzoparibDrug
Fluzoparib：150mg was given orally twice daily Camrelizumab：200 mg IV drip on Day 1 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+Fluzoparib | Experimental | Fluzoparib combined with Carolizumab for 8 cycles of neoadjuvant therapy. Allowing the continued use of combination therapy or monotherapy with Carolizumab and fluzoparib during the adjuvant therapy phase, with an overall treatment duration not exceeding 12 months. Receives: Drug: Camrelizumab+Fluzoparib |
What is being measured
The primary outcome is the main question the study is designed to answer.
tpCR（ypT0/is ypN0）
total pathological complete response
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2022
- Study start1 Oct 2022
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Germline BRCA-mutated HER2-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Shu Wang, Peking University People's Hospital
- Investigators
- Shu Wang, Dr., Principal investigator, Breast Center, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05576389
- Sponsor's protocol ID
- MA-BC-II-034
- Status last verified
- Jul 2026
- First submitted
- 13 Sep 2022
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluzoparib Combined With Camrelizumab for Neoadjuvant Treatment of Embryogenic BRCA Mutation HER2 Negative Breast Cancer: an Open, Single Arm, Multicenter Study
- ClinicalTrials.gov ID
- NCT05576389
- Acronym / sponsor ID
- MA-BC-II-034
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 12 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is an open-label, single-arm, multicenter clinical study. 64 patients with germline BRCA-mutated HER2-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of neoadjuvant fluzoparib combined with camrelizumab in the treatment of germline BRCA-mutated HER2-negative early breast cancer。
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+Fluzoparib | Experimental | Drug: Camrelizumab+FluzoparibFluzoparib combined with Carolizumab for 8 cycles of neoadjuvant therapy. Allowing the continued use of combination therapy or monotherapy with Carolizumab and fluzoparib during the adjuvant therapy phase, with an overall treatment duration not exceeding 12 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- According to the definition of the latest ASCO/CAP guidelines, early or locally advanced HER2 negative invasive breast cancer confirmed by histopathology meets the following conditions:
- Patients with bilateral breast cancer whose primary lesions all meet the inclusion criteria, or breast cancer with Tis-1bN0 and HER2 negative on the other side only meeting the inclusion criteria on one side;
- The hormone receptor status is known;
- ECOG score 0-1;
- Carrying BRCA1 or BRCA2 germline pathogenic mutations or suspected pathogenic mutations;
Key exclusion criteria (10 listed)
- Tumor related symptoms and treatment
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis or combined hepatitis B and C co-infection; autoimmune hepatitis;
- Confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia; angina requiring antianginal medication
- Female patients who are pregnant or lactating
- History of definite neurological or psychiatric disorders, including epilepsy or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Camrelizumab+FluzoparibFluzoparib：150mg was given orally twice daily Camrelizumab：200 mg IV drip on Day 1 of each cycle | Drug | Camrelizumab+Fluzoparib |
Primary outcome
tpCR（ypT0/is ypN0）
Time frame: 6 months
total pathological complete response
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shu Wang, Dr. principal investigator
Breast Center, Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab+Fluzoparib in people with Germline BRCA-mutated HER2-negative Breast Cancer, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shu Wang, Dr. (13801080201, xiefei@pkuph.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tpCR（ypT0/is ypN0） (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.