Advanced HER2 Negative Breast CarcinomaPhase 2NCT05085626
Fluzoparib in Combination With Chidamide or Camrelizumab for HRD Positive HER2 Negative Advanced Breast Cancer
A Phase 2 study testing fluzoparib+chidamide and fluzoparib+camrelizumab in people with Advanced HER2 Negative Breast Carcinoma and HRD+Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This study is planned to include 40 patients with HER2-negative advanced breast cancer to receive fluzoparib combined with chidamide or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with camrelizumab or chidamide in the treatment of HRD-positive… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Advanced HER2 Negative Breast Carcinoma, HRD+Breast Cancer
- What is being tested?
- fluzoparib+chidamide and fluzoparib+camrelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2021to 31 Dec 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- histologically confirmed initial stage IV breast cancer or recurrent metastatic breast cancer; advanced treatment stage received at least 1 line of chemotherapy but no more than 2 lines of chemotherapy; hormone receptor-positive patients received at least one endocrine therapy in advanced treatment stage, or the investigator judged that they were not suitable for endocrine therapy; and patients with hormone receptor-positive advanced breast cancer who progressed within 2 years of adjuvant endocrine therapy.
- histologically confirmed invasive HER2-negative breast cancer (specific definition: HER20-1 + or HER2 2 + by immunohistochemistry but negative or no amplification by FISH or CISH, following the 2018 version of the ASCO-CAPHER2 guidelines for negative interpretation);
- central confirmation of HRD positivity, known germline BRCA and/or systemic BRCA mutation status is allowed to be preferred.
- age 18-70 years
- According to RECIST 1.1, at least one measurable lesion is present;
- ECOG score: 0-2; expected survival more than 12 weeks;
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- Previous treatment with immune checkpoint inhibitors, PARP inhibitors and HDAC inhibitors (including chidamine, romidepsin, vorinostat, benirestat, parastat, etc.);
- All acute toxicities caused by previous anti-tumor treatment return to the level specified in the inclusion/exclusion criteria (except alopecia and other toxicities that are considered by the investigator to pose no safety risk to the subjects);
- Female subjects of childbearing potential need to use a medically recognized contraceptive measure during the study treatment and at least 3 months after the last use of the study drug;
- Patients with known hormone receptor status;
- Main organ function is basically normal, and meet the following conditions:
- Blood routine examination criteria need to meet: HB ≥ 90 g/L (14 without blood transfusion); ANC ≥ 1.5 × 109/L; PLT ≥ 75 × 109/L;
- Biochemical examination need to meet the following criteria: TBIL ≤ 1.5 × ULN (upper limit of normal); ALT and AST ≤ 3 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN; serum Cr ≤ 1 × ULN;
- cardiac function: LVEF ≥ 50%
- The subject voluntarily joined the study and signed the informed consent form.
Who cannot join
- Uncontrolled central nervous system metastasis (defined as symptoms or requiring glucocorticoids or mannitol to control symptoms);
- Clinically symptomatic third space effusion, pericardial effusion, pleural effusion and abdominal effusion that cannot be controlled by pumping or other treatments;
- Currently or recently (within 30 days before enrollment) is participating in another clinical study;
- Five Other malignant tumors (except adequately treated cervical carcinoma in situ or skin squamous cell carcinoma or controlled skin basal cell carcinoma) within the past 4 years;
- Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA grade 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc > 470 ms;
- Hyperactive/venous thrombotic events, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep venous thrombosis and pulmonary embolism;
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- He following history 24 days before signing the ICF: gastrointestinal ulcers, gastrointestinal perforation, corrosive esophagitis or gastritis, inflammatory bowel disease or inflammation, abdominal fistula, tracheoesophageal fistula or intra-abdominal abscess;
- Factors that significantly affect oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;
- Patients with a clear history of allergy, Potential allergy or intolerance to cidaniline, fluzoparib, and carreizumab;
- Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B surface antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method);
- Female patients during pregnancy and lactation, female patients of childbearing potential with positive baseline pregnancy test or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
- According to the investigator's judgment, the presence of concomitant diseases (including but not limited to hypertension with poor drug control, severe diabetes, neurological or psychiatric diseases, active infection, etc.) or any other condition that seriously endangers the subject's safety, may confound the study results, or affect the subject's completion of this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality
Chunfang Hao, 18622223686, haochf@163.com
Silu Wang, 18559171530, wangsiluaaron@163.com
About this study
Official title: An Open, Multi-center, Cohort Clinical Study of Fluzoparib in Combination With Chidamide or Camrelizumab for HRD Positive and HER2-negative Advanced Breast Cancer
This study is planned to include 40 patients with HER2-negative advanced breast cancer to receive fluzoparib combined with chidamide or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with camrelizumab or chidamide in the treatment of HRD-positive HER2-negative advanced breast cancer.
- Being tested
- fluzoparib+chidamide, fluzoparib+camrelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluzoparib+chidamideDrug
Arms A will be treated with fluzoparib in combination with cedaramide
fluzoparib+camrelizumabDrug
Arms B will be treated with fluzoparib in combination with camrelizumab
| Study group | Role | What they receive |
|---|---|---|
| fluzoparib+chidamide | Experimental | Fluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance.
Chidamide: It is recommended to take 20 mg (4 tablets) twice a week, with an interval of no less than 3 days between doses (such as Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), for 30 minutes. Until disease progression or intolerable to patient. Receives: Drug: fluzoparib+chidamide |
| 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.
ORR(objective response rate)
through study completion, an average of 6 months
Measured: At the end of Cycle 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start8 Feb 2021
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
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 CarcinomaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085626
- Sponsor's protocol ID
- BC-Fluzoparib
- Status last verified
- Sep 2022
- First submitted
- 29 Jun 2021
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multi-center, Cohort Clinical Study of Fluzoparib in Combination With Chidamide or Camrelizumab for HRD Positive and HER2-negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT05085626
- Acronym / sponsor ID
- BC-Fluzoparib
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 8 Feb 2021 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Oct 2021 (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 40 patients with HER2-negative advanced breast cancer to receive fluzoparib combined with chidamide or fluzoparib combined with camrelizumab to observe and evaluate the efficacy and safety of fluzoparib combined with camrelizumab or chidamide in the treatment of HRD-positive HER2-negative advanced breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluzoparib+chidamide | Experimental | Drug: fluzoparib+chidamideFluzoparib: 150 mg twice daily (morning and evening) for 21 consecutive days as a cycle until disease progression or intolerance. Chidamide: It is recommended to take 20 mg (4 tablets) twice a week, with an interval of no less than 3 days between doses (such as Monday and Thursday, Tuesday and Friday, Wednesday and Saturday, etc.), for 30 minutes. Until disease progression or intolerable to patient. |
| 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- histologically confirmed initial stage IV breast cancer or recurrent metastatic breast cancer; advanced treatment stage received at least 1 line of chemotherapy but no more than 2 lines of chemotherapy; hormone receptor-positive patients received at least one endocrine therapy in advanced treatment stage, or the investigator judged that they were not suitable for endocrine therapy; and patients with hormone receptor-positive advanced breast cancer who progressed within 2 years of adjuvant endocrine therapy.
- histologically confirmed invasive HER2-negative breast cancer (specific definition: HER20-1 + or HER2 2 + by immunohistochemistry but negative or no amplification by FISH or CISH, following the 2018 version of the ASCO-CAPHER2 guidelines for negative interpretation);
- central confirmation of HRD positivity, known germline BRCA and/or systemic BRCA mutation status is allowed to be preferred.
- age 18-70 years
- According to RECIST 1.1, at least one measurable lesion is present;
Key exclusion criteria (12 listed)
- Uncontrolled central nervous system metastasis (defined as symptoms or requiring glucocorticoids or mannitol to control symptoms);
- Clinically symptomatic third space effusion, pericardial effusion, pleural effusion and abdominal effusion that cannot be controlled by pumping or other treatments;
- Currently or recently (within 30 days before enrollment) is participating in another clinical study;
- Five Other malignant tumors (except adequately treated cervical carcinoma in situ or skin squamous cell carcinoma or controlled skin basal cell carcinoma) within the past 4 years;
- Uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA grade 2 or higher heart failure (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) QTc > 470 ms;
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 |
|---|---|---|
| fluzoparib+chidamideArms A will be treated with fluzoparib in combination with cedaramide | Drug | fluzoparib+chidamide |
| fluzoparib+camrelizumabArms B will be treated with fluzoparib in combination with camrelizumab | Drug | fluzoparib+camrelizumab |
Primary outcome
ORR(objective response rate)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
through study completion, an average of 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- Individual participant dataSharing planned: No
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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.
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+chidamide and fluzoparib+camrelizumab in people with Advanced HER2 Negative Breast Carcinoma and HRD+Breast Cancer, run by Tianjin Medical University Cancer Institute and 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 15 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 29 Sep 2022. 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?
Contact Chunfang Hao (18622223686, haochf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR(objective response rate) (time frame: At the end of Cycle 1 (each cycle is 28 days)). 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 29 Sep 2022; AzTrials last refreshed its copy on 26 Oct 2026.