TNBC - Triple-Negative Breast CancerPhase 2NCT05834582
Neoadjuvant Fluzoparib in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer
A Phase 2 study testing Fluzoparib+Paclitaxel and Epirubicin+Cyclophosphamide in people with TNBC - Triple-Negative Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
Although many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Fluzoparib+Paclitaxel and Epirubicin+Cyclophosphamide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2023to 1 Jun 2026
- 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 and ≤ 70 years of age with treatment-naïve breast cancer
- Histopathologically confirmed early or locally advanced three-negative invasive breast cancer as defined by the ASCO/CAP guidelines while meeting the following conditions:
- HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; ER and/or PR negative (not eligible for endocrine therapy): IHC nuclear staining ≤ 1%
- Tumor stage: II-III: Primary tumor size: ≥ 2cm
- ECOG score 0 ~ 1;
- Centrally confirmed BRCA1 or BRCA2 germline mutation;
- Eligible level of organ function
Who cannot join
- Patients with metastatic breast cancer or bilateral breast cancer or inflammatory breast cancer;
- Participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, immunotherapy, biological therapy or tumor embolization;
- Previously received PARPi therapy;
- History of another primary malignancy;
- Confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia;
- Female patients who are pregnant or lactating;
- History of allergy to drugs in this study；
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
JiangSu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
Xiaoan Liu, Professor, 025-68308162, liuxiaoan@126.com
About this study
Official title: Neoadjuvant Fluzoparib Combined With Chemotherapy in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer: an Open, Multicenter, Cohort Trial
Although many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. 60 patients with germline BRCA-mutated three-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with chemotherapy according to tumor response after EC (epirubicin and cyclophosphamide) for 2 cycles.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- Fluzoparib+Paclitaxel, Epirubicin+Cyclophosphamide
- Keywords
- three-negative Breast Cancer with germline BRCA-mutated
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzoparib+PaclitaxelDrug
Fluzoparib+Paclitaxel for 4 cycles if tumor response is SD after 2 cycles of EC induced chemotherapy
Epirubicin+CyclophosphamideDrug
Epirubicin+Cyclophosphamide
| Study group | Role | What they receive |
|---|---|---|
| Cohort1: Epirubicin+Cyclophosphamide | Experimental | 2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is CR or PR: Epirubicin+Cyclophosphamide for 2 cycles Fluzoparib+Paclitaxel for 2 cycles Receives: Drug: Fluzoparib+Paclitaxel; Drug: Epirubicin+Cyclophosphamide |
| Cohort2: Fluzoparib+Paclitaxel | Experimental | 2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is SD: Fluzoparib+Paclitaxel for 4 cycles Receives: Drug: Fluzoparib+Paclitaxel; Drug: Epirubicin+Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
tpCR（ypT0/is ypN0）
pCR is defined as the absence of invasive residual disease in the breast and in the axillary lymph nodes (ypT0/is ypN0).
Measured: 6 months from the patients enrolled
Secondary outcomes (2)
Event-free Survival (EFS) as assessed by Investigator
EFS is defined as the time from enrollment to disease progression or death due to any cause
Measured: Up to approximately 3 years
AEs and SAEs
adverse events and serious adverse events
Measured: From enrollment to the surgery (approximately 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start8 Apr 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Liu Xiaoan, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Xiaoan Liu, Professor, Principal investigator, Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05834582
- Sponsor's protocol ID
- MA-BC-II-050
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2023
- Last updated
- 28 Apr 2023
- 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Fluzoparib Combined With Chemotherapy in Germline BRCA-mutated Three-negative Breast Cancer Breast Cancer: an Open, Multicenter, Cohort Trial
- ClinicalTrials.gov ID
- NCT05834582
- Acronym / sponsor ID
- MA-BC-II-050
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Keywords
- three-negative Breast Cancer with germline BRCA-mutated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 8 Apr 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 28 Apr 2023 (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.
Although many PARP inhibitors did not improve pCR in neoadjuvant studies, it is not an unchallenged conclusion that TNBC does not benefit from use of PARP inhibitors in neoadjuvant therapy.This study is an open-label, two-cohort, multicenter trial. 60 patients with germline BRCA-mutated three-negative early breast cancer are planned to be enrolled and treated with fluzoparib combined with chemotherapy according to tumor response after EC (epirubicin and cyclophosphamide) for 2 cycles.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort1: Epirubicin+Cyclophosphamide | Experimental | Drug: Fluzoparib+Paclitaxel, Drug: Epirubicin+Cyclophosphamide2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is CR or PR: Epirubicin+Cyclophosphamide for 2 cycles Fluzoparib+Paclitaxel for 2 cycles |
| Cohort2: Fluzoparib+Paclitaxel | Experimental | Drug: Fluzoparib+Paclitaxel, Drug: Epirubicin+Cyclophosphamide2 cycles of EC (Epirubicin+Cyclophosphamide) induced chemotherapy, if tumor response is SD: Fluzoparib+Paclitaxel for 4 cycles |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women ≥ 18 and ≤ 70 years of age with treatment-naïve breast cancer
- Histopathologically confirmed early or locally advanced three-negative invasive breast cancer as defined by the ASCO/CAP guidelines while meeting the following conditions:
- HER2 negative: IHC 0/1 + or IHC2 + but ISH negative; ER and/or PR negative (not eligible for endocrine therapy): IHC nuclear staining ≤ 1%
- Tumor stage: II-III: Primary tumor size: ≥ 2cm
- ECOG score 0 ~ 1;
Key exclusion criteria (7 listed)
- Patients with metastatic breast cancer or bilateral breast cancer or inflammatory breast cancer;
- Participated in other drug trials or received any anti-tumor therapy within 4 weeks before enrollment, including endocrine therapy, immunotherapy, biological therapy or tumor embolization;
- Previously received PARPi therapy;
- History of another primary malignancy;
- Confirmed history of heart failure or systolic dysfunction (LVEF < 50%); high risk uncontrolled cardiac arrhythmias, such as atrial tachycardia;
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+PaclitaxelFluzoparib+Paclitaxel for 4 cycles if tumor response is SD after 2 cycles of EC induced chemotherapy | Drug | Cohort1: Epirubicin+Cyclophosphamide, Cohort2: Fluzoparib+Paclitaxel |
| Epirubicin+CyclophosphamideEpirubicin+Cyclophosphamide | Drug | Cohort1: Epirubicin+Cyclophosphamide, Cohort2: Fluzoparib+Paclitaxel |
Primary outcome
tpCR（ypT0/is ypN0）
Time frame: 6 months from the patients enrolled
pCR is defined as the absence of invasive residual disease in the breast and in the axillary lymph nodes (ypT0/is ypN0).
2 secondary outcomes
Event-free Survival (EFS) as assessed by Investigator
Time frame: Up to approximately 3 years
AEs and SAEs
Time frame: From enrollment to the surgery (approximately 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- 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.
Xiaoan Liu, Professor principal investigator
Jiangsu Province Hospital/ The First Affiliated Hospital of Nanjing Medical 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+Paclitaxel and Epirubicin+Cyclophosphamide in people with TNBC - Triple-Negative Breast Cancer, run by The First Affiliated Hospital with Nanjing Medical University 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 7 inclusion and 7 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 28 Apr 2023. 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 Xiaoan Liu, Professor (025-68308162, liuxiaoan@126.com), 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 from the patients enrolled). 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 28 Apr 2023.