Advanced HER2 Negative Breast Carcinoma HRD+Breast CancerPhase 2NCT05656131
Fluzoparib in Combination With or Without Camrelizumab for Homologous Recombinant Deficiency (HRD) HER2 Negative Advanced Breast Cancer
A Phase 2 study testing Fluzoparib and Fluzoparib+Camrelizumab in people with Advanced HER2 Negative Breast Carcinoma HRD+Breast Cancer, run by wang shusen at 1 site in China.
Trial summary
This study is planned to include 80 patients with HRD positive HER2-negative advanced breast cancer to receive fluzoparib alone or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with or without camrelizumab in the treatment of HRD positive HER2-negative… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Advanced HER2 Negative Breast Carcinoma HRD+Breast Cancer
- What is being tested?
- Fluzoparib and Fluzoparib+Camrelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2022to 31 Dec 2027
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥18 years old
- Histologically or cytologically confirmed locally advanced or metastatic breast cancer.
- Pathologically documented breast cancer that is HER2-negative for both primary tumor and metastases (if puncture results are available)
- ECOG PS of 0-1.
- For locally advanced or metastatic breast cancer, the tumor tissue HRD score> 42 is needed (for HRD testing, the recipient must provide a test report from an institution with a qualified testing unit prior to enrollment; if no report is available, the relevant test sample must be provided for confirmation in the central laboratory prior to enrollment).
- Presence of at least 1 measurable lesion based on computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1).
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- If treated with PARP inhibitors or immune checkpoint inhibitors in the (neo) adjuvant phase, a relapse-free interval of more than 1 year after the end of treatment is required.
- Prior treatment with paclitaxel-based chemotherapeutic agents is allowed.
- ≤ 2 lines of prior chemotherapy in the advanced stage.
- For HR+ patients, progression within two years of (neo) adjuvant endocrine therapy is required; patients who have progressed after more than two years of endocrine therapy are required to have received at least first-line endocrine therapy for metastatic disease (including CDK4/6 inhibitors, cidarabine and PI3K inhibitors, etc.).
- ≤ grade 1 (CTCAE v5.0) for all toxicities occurring in relation to prior antitumor therapy. However, patients with any grade of alopecia are allowed to enter the study.
- CNS metastases without symptoms may be enrolled.
- If there is no extracranial assessable lesion, intracranial lesions are required to be assessable and suitable for systemic therapy only
- If there is an extracranial evaluable lesion, patients with an intracranial lesion that has been stabilized with local therapy may be accepted for enrollment
- Routine blood tests within 1 week prior to enrollment are essentially normal.
- White blood cell count (WBC) ≥ 2.5 × 109/L.
- Neutrophil count (ANC) ≥ 1.5 × 109/L.
- Platelet count (PLT) ≥ 75 × 109/L.
- Patients may receive blood transfusions or erythropoietin therapy to meet this criterion.
- Basic normal liver and renal function tests within 1 week prior to enrollment.
- Total bilirubin (T BIL) ≤ 1.5 x the upper limit of normal (ULN).
- Glutathione transaminase (SGPT/ALT) ≤ 2.5 x ULN (≤ 5 x ULN in patients with liver metastases).
- Glutathione aminotransferase (SGOT/AST) ≤ 2.5× ULN (≤ 5× ULN in patients with liver metastases).
- creatinine clearance (Ccr) ≥ 60 ml/min.
- Patients subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose of treatment medicine for at least 90 days.
- A life expectancy of at least 12 weeks.
- Patients must be able to participate and comply with treatment and follow-up.
Who cannot join
- Has multiple primary malignancies and requires standardized treatment or major surgery within 2 years of the first dose of study treatment.
- Treated with PARP inhibitors in advanced stages.
- BRCA1/2 germline mutation.
- Symptomatic or unstable brain metastases.
- Any severe or poorly controlled systemic disease such as poorly controlled hypertension, active bleeding susceptibility or active infection, as judged by the investigator. Chronic disease needs to be excluded.
- Refractory nausea, vomiting or chronic gastrointestinal disease, inability to swallow study drug or previous extensive bowel resection that may interfere with adequate absorption of PARP inhibitors.
- Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, interstitial lung disease, pulmonary emboli within three months of the study enrollment, severe asthma, severe chronic obstructive pulmonary disease [COPD], restrictive lung disease, pleural effusion etc), and any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement (ie, rheumatoid arthritis, Sjögren's, sarcoidosis etc), or prior pneumonectomy.
- Otherwise considered inappropriate for the study by the Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fluzoparib in Combination With or Without Camrelizumab for Homologous Recombinant Deficiency (HRD) HER2 Negative Advanced Breast Cancer，A Two-cohort, Open, Multicenter，Phase II Study
This study is planned to include 80 patients with HRD positive HER2-negative advanced breast cancer to receive fluzoparib alone or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with or without camrelizumab in the treatment of HRD positive HER2-negative advanced breast cancer.
- Being tested
- Fluzoparib, Fluzoparib+Camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluzoparibDrug
Arms A will be treated with fluzoparib alone
Fluzoparib+CamrelizumabDrug
Arms B will be treated with fluzoparib in combination with camrelizumab
| Study group | Role | What they receive |
|---|---|---|
| fluzoparib | Experimental | Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance. Receives: Drug: Fluzoparib |
| fluzoparib+Camrelizumab | Experimental | Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance.
Camrelizumab: 200 mg IV drip over approximately 30 minutes (no less than 20 minutes and no more than 60 minutes) on Day 1 of each 3-week treatment cycle until disease progression or intolerance. Receives: Drug: Fluzoparib+Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1.recorded from randomization until disease progression or death due to any cause
Measured: Up to 3 years
Secondary outcomes (4)
Progress-free survival
Time from randomization to the first documentation of objective tumor progression or to death due to any cause
Measured: Up to 3 years
Overall Survival
Time from randomization to date of death due to any cause. according to the RECIST version 1.1 recorded in the time period between randomization and disease progression or death to any cause.
Measured: Up to 3 years
QoL questionnaire （quality of life）
Measured: Up to 3 years
Adverse effect (AE)
Any adverse effect occurred in the treatment
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start23 Nov 2022
- Primary completion30 Mar 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Suspended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced HER2 Negative Breast Carcinoma HRD+Breast CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wang shusen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wang shusen, Sun Yat-sen University
- Investigators
- shusen Wang, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656131
- Sponsor's protocol ID
- MA-BC-II-042
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2022
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluzoparib in Combination With or Without Camrelizumab for Homologous Recombinant Deficiency (HRD) HER2 Negative Advanced Breast Cancer，A Two-cohort, Open, Multicenter，Phase II Study
- ClinicalTrials.gov ID
- NCT05656131
- Acronym / sponsor ID
- MA-BC-II-042
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Suspended
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- wang shusenUniversity, hospital or other
- Study start
- 23 Nov 2022 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 19 Dec 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 planned to include 80 patients with HRD positive HER2-negative advanced breast cancer to receive fluzoparib alone or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with or without camrelizumab in the treatment of HRD positive HER2-negative advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluzoparib | Experimental | Drug: FluzoparibFluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance. |
| fluzoparib+Camrelizumab | Experimental | Drug: Fluzoparib+CamrelizumabFluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance. Camrelizumab: 200 mg IV drip over approximately 30 minutes (no less than 20 minutes and no more than 60 minutes) on Day 1 of each 3-week treatment cycle until disease progression or intolerance. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Women ≥18 years old
- Histologically or cytologically confirmed locally advanced or metastatic breast cancer.
- Pathologically documented breast cancer that is HER2-negative for both primary tumor and metastases (if puncture results are available)
- ECOG PS of 0-1.
- For locally advanced or metastatic breast cancer, the tumor tissue HRD score> 42 is needed (for HRD testing, the recipient must provide a test report from an institution with a qualified testing unit prior to enrollment; if no report is available, the relevant test sample must be provided for confirmation in the central laboratory prior to enrollment).
Key exclusion criteria (8 listed)
- Has multiple primary malignancies and requires standardized treatment or major surgery within 2 years of the first dose of study treatment.
- Treated with PARP inhibitors in advanced stages.
- BRCA1/2 germline mutation.
- Symptomatic or unstable brain metastases.
- Any severe or poorly controlled systemic disease such as poorly controlled hypertension, active bleeding susceptibility or active infection, as judged by the investigator. Chronic disease needs to be excluded.
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 |
|---|---|---|
| FluzoparibArms A will be treated with fluzoparib alone | Drug | fluzoparib |
| Fluzoparib+CamrelizumabArms B will be treated with fluzoparib in combination with camrelizumab | Drug | fluzoparib+Camrelizumab |
Primary outcome
Objective Response Rate
Time frame: Up to 3 years
Objective response is defined as a complete response (CR) or partial response (PR) according to RECIST v.1.1.recorded from randomization until disease progression or death due to any cause
4 secondary outcomes
Progress-free survival
Time frame: Up to 3 years
Overall Survival
Time frame: Up to 3 years
QoL questionnaire （quality of life）
Time frame: Up to 3 years
Adverse effect (AE)
Time frame: Up to 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Advanced HER2 Negative Breast Carcinoma HRD+Breast Cancer
Active, not recruitingPhase 3
Fluorizoparib Plus Apatinib Versus Chemotherapy in HRD-positive, HER2-negative Advanced Breast Cancer
Metastatic Breast Cancer, HRD-Positive/HER2-Negative Advanced Breast Cancer
RecruitingPhase 3
Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer
Fludzoparib" and Anti-angiogenic, HRD-positive/HER2-negative Advanced Breast Cancer
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. This study is not recruiting at the moment.
shusen Wang principal investigator
Sun Yat-sen University
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 Fluzoparib and Fluzoparib+Camrelizumab in people with Advanced HER2 Negative Breast Carcinoma HRD+Breast Cancer, run by wang shusen 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 27 inclusion and 8 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: paused, as of the sponsor's last update on 17 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: Up to 3 years). 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 17 Mar 2026.