Platinum-sensitivePhase 2Fzp-MA-TNBCNCT07321015
A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance
A Phase 2 study testing Fluzoparib Monotherapy in people with Platinum-sensitive and TNBC, Triple Negative Breast Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
Breast cancer is the most common malignancy in women; approximately 5-10% are hereditary, with 14% of triple-negative breast cancers (TNBC) harboring BRCA mutations. BRCA1/2 are essential for homologous recombination repair of DNA double-strand breaks, whereas PARP mediates base-excision repair of single-strand… Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Platinum-sensitive, TNBC, Triple Negative Breast Cancer, BRCA1/2 Mutation or Not
- What is being tested?
- Fluzoparib Monotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2026to 30 Nov 2027
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years (inclusive) at the time of informed consent.
- Histologically confirmed triple-negative breast cancer (TNBC; ER <1%, PR <1%, HER2-negative).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Received ≥2 prior lines of systemic therapy, including a platinum-based regimen (single-agent or combination); must have achieved partial response (PR) or stable disease (SD) during or after that platinum-based treatment.
- Platinum-sensitive disease defined as: Objective response (complete or partial) or stable disease lasting ≥6 months while on platinum-based therapy, or Platinum-free interval (PFI) ≥6 months from the end of the last platinum-containing regimen to documented progression/relapse.
- Estimated life expectancy ≥3 months.
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- At least one measurable lesion per RECIST 1.1 on CT/MRI; evidence of metastatic disease (soft-tissue and/or bone lesions) is required.
- Willing to provide archived tumour tissue (core biopsy or excision) or fresh biopsy/blood for biomarker analyses.
- Adequate organ function within 14 days (7 days for liver enzymes) before first dose:
- Absolute neutrophil count ≥1.5 × 10⁹/L Platelets ≥100 × 10⁹/L Haemoglobin ≥80 g/L Total bilirubin ≤1.5 × upper limit of normal (ULN) ALT \& AST ≤2.5 × ULN (≤5 × ULN if liver metastases present) Serum creatinine ≤1.25 × ULN and calculated creatinine clearance ≥60 mL/min
- Toxicities from prior anti-cancer therapy resolved to Grade ≤1 per NCI-CTCAE v5.0 (except alopecia or other stable chronic toxicities deemed tolerable by the investigator).
- Participants of reproductive potential and their partners must agree to use highly effective contraception from 30 days before the first dose until 120 days after the last dose of fluzoparib.
- Signed written informed consent prior to any study-specific procedures.
Who cannot join
- Known hypersensitivity to fluzoparib or any of its excipients.
- Prior treatment with any PARP inhibitor.
- Use of strong CYP3A4 inhibitors within 14 days or strong CYP3A4 inducers within 28 days before first dose.
- Wash-out interval <4 weeks from any prior anti-cancer therapy (chemotherapy, radiotherapy, surgery, targeted therapy, immunotherapy) to first dose.
- Planned anti-cancer therapy other than study drug during the trial period.
- Severe bone complications from bone metastases (uncontrolled pain, impending pathological fracture, or spinal cord compression within 6 months or judged likely to occur).
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- Symptomatic or untreated brain metastases, leptomeningeal disease, spinal cord compression, or primary CNS tumors. (Stable brain metastases treated ≥28 days prior to first dose, without steroids and with confirmatory imaging showing no hemorrhage, may be allowed at investigator's discretion.)
- Active autoimmune disease requiring systemic therapy within the past 2 years.
- Recovery from major surgery under general anesthesia or severe trauma <14 days before start of study treatment.
- Active hepatitis B (HBsAg positive and HBV DNA ≥500 IU/mL) or hepatitis C (anti-HCV positive and HCV RNA >ULN).
- Untreated CNS metastases.
- History of immunodeficiency (including HIV positive), congenital or acquired, or prior solid-organ transplant.
- Other malignancies within 5 years except adequately treated carcinoma in situ or indolent tumors judged by the investigator to have low risk of recurrence.
- Alcohol abuse (>14 units/week) or drug abuse; inability to stop smoking (>10 cigarettes/day), nicotine products, grapefruit juice, or excessive caffeine/tea during the study.
- History of non-infectious pneumonitis requiring steroids or current pneumonitis.
- Clinically significant ECG abnormalities, including QTcF >470 ms in females (QTc calculated with Fredericia's formula).
- Conditions that could impair oral absorption: inability to swallow, active GI disease, bowel obstruction, inflammatory bowel disease, chronic diarrhea, short-bowel syndrome, or major upper-GI surgery (e.g., gastrectomy).
- Active infection or unexplained fever >38.5 °C on screening or day 1 (tumor fever allowed if investigator judges stable).
- Uncontrolled chronic systemic diseases (severe pulmonary, hepatic, renal, or cardiac).
- Thyroid function abnormalities (TSH, FT3, FT4) deemed clinically significant by the investigator.
- Bleeding diathesis: active peptic ulcer with positive fecal occult blood (FOB ++), melena or hematemesis within 2 months, or any condition predisposing to GI hemorrhage; gastric ulcer-type tumor without resection and judged at high risk of major bleeding; on thrombolytic/anticoagulant therapy that cannot be safely interrupted.
- Urinalysis ≥++ proteinuria confirmed by 24-h urine protein >1.0 g.
- Arterial or venous thrombo-embolic events (stroke, TIA, DVT, PE) within 6 months before screening.
- Active tuberculosis or acute infection requiring anti-infective therapy.
- Live-vaccine administration within 30 days before planned first dose.
- Additional exclusion: Any severe concomitant condition that, in the investigator's opinion, could compromise patient safety or interfere with study compliance (e.g., uncontrolled diabetes, thyroid disorders, psychiatric illness).
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
Tianjin Medical University Cancer Institute and Hospital
Tianjin
Zhao, +86+022-23109106, maoxun1977@163.com
About this study
Official title: An Exploratory Single-Arm Study of Maintenance Fluzoparib in Platinum-Sensitive, Advanced Triple-Negative Breast Cancer Patients With BRCA1/2 Mutation or Wild-Type BRCA
Breast cancer is the most common malignancy in women; approximately 5-10% are hereditary, with 14% of triple-negative breast cancers (TNBC) harboring BRCA mutations. BRCA1/2 are essential for homologous recombination repair of DNA double-strand breaks, whereas PARP mediates base-excision repair of single-strand breaks. PARP inhibitors (PARPi) exploit synthetic lethality to selectively eliminate BRCA-deficient tumor cells. Olaparib and talazoparib have demonstrated superior PFS and ORR versus chemotherapy in BRCA-mutated, HER2-negative advanced breast cancer, leading to FDA approval. In ovarian cancer, PARPi maintenance improves overall survival, with consistent benefits observed in Asian populations. The domestically developed PARPi fluzoparib, engineered with a trifluoromethyl moiety for enhanced stability and tissue penetration, showed in the phase III FABULOUS trial a median PFS of 6.7 vs 3.0 months and an ORR of 43.6% vs 23.3% compared with chemotherapy in gBRCA-mutated, HER2-negative breast cancer, with manageable safety. Data remain limited in Chinese patients and those with BRCA wild-type disease. This study aims to evaluate the efficacy and safety of fluzoparib maintenance monotherapy in advanced TNBC patients-either BRCA1/2-mutated or wild-type-who have derived clinical benefit from prior platinum-based therapy.
- Being tested
- Fluzoparib Monotherapy
- Keywords
- TNBC, Platinum-sensitive, Maintenance Therapy
- 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 MonotherapyDrug
Fluzoparib is an oral poly (ADP-ribose) polymerase (PARP) inhibitor supplied as 50 mg capsules. Participants take 150 mg twice daily (total 300 mg/day) on days 1-28 of each 28-day cycle. Doses should be swallowed whole with water, approximately 12 hours apart, at approximately the same times each day. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death. Dose interruptions or reductions (stepwise to 100 mg BID or 50 mg BID) are allowed for haematological or non-haematological toxicities graded ≥3 or as clinically indicated. No concurrent anticancer therapy is permitted during fluzoparib maintenance.
| Study group | Role | What they receive |
|---|---|---|
| Fluzoparib Maintenance Until Disease Progression or Intolerable Toxicity | Experimental | Patients with advanced triple-negative breast cancer who have achieved at least stable disease (SD) or partial response (PR) after ≥2 prior lines of therapy including a platinum-based regimen will receive fluzoparib 150 mg orally twice daily on days 1-28 of each 28-day cycle. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death. Dose interruptions or reductions (to 100 mg BID or 50 mg BID) are allowed for predefined toxicities. No concurrent anticancer therapy is permitted. Efficacy assessments (CT/MRI) will be performed every 6 weeks (2 cycles) from the first dose. Exploratory biomarkers (PD-L1, TILs, CD4/8, cytokines) will be collected optionally for subgroup analyses. Receives: Drug: Fluzoparib Monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Time from first fluzoparib dose to first radiological disease progression (RECIST 1.1) or death from any cause, whichever occurs first.
Measured: From first dose of fluzoparib until disease progression or death, assessed every 6 weeks (2 cycles), up to approximately 12 months
Secondary outcomes (5)
Second progression-free survival (PFS2)
Time from first dose of fluzoparib to the earliest of: radiological progression on next-line therapy, start of non-protocol anti-cancer treatment, or death from any cause.
Measured: From first fluzoparib dose until the above events, assessed every 6 weeks while on study and subsequently, up to approximately 24 months.
Duration of response (DoR)
Time from first documented complete or partial response (CR/PR) to subsequent radiological disease progression (RECIST 1.1) or death from any cause, whichever occurs first, among patients who achieved CR/PR
Measured: From first CR/PR documentation until progression or death, assessed every 6 weeks while on fluzoparib, up to approximately 24 months.
Disease control rate (DCR)
Proportion of participants achieving complete response, partial response, or stable disease (CR + PR + SD) lasting ≥ 6 weeks, assessed by RECIST 1.1
Measured: From first dose of fluzoparib until the 6-week tumor assessment, up to approximately 2 months.
Overall survival (OS)
Time from first dose of fluzoparib to death from any cause.
Measured: From first fluzoparib dose until death, assessed up to approximately 36 months.
Incidence and severity of adverse events (AE)
All adverse events will be recorded from first dose of fluzoparib until 30 days after last dose, graded by CTCAE v5.0.
Measured: From first fluzoparib dose up to 30 days after last dose, assessed throughout the study and during follow-up, expected up to approximately 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2026
- Study start20 Jan 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platinum-sensitiveStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321015
- Sponsor's protocol ID
- EK20250453
- Acronym
- Fzp-MA-TNBC
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 21 Aug 2026
- Results posted
- 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 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Single-Arm Study of Maintenance Fluzoparib in Platinum-Sensitive, Advanced Triple-Negative Breast Cancer Patients With BRCA1/2 Mutation or Wild-Type BRCA
- ClinicalTrials.gov ID
- NCT07321015
- Acronym / sponsor ID
- Fzp-MA-TNBC / EK20250453
- Keywords
- TNBC, Platinum-sensitive, Maintenance Therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 6 Jan 2026 (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.
Breast cancer is the most common malignancy in women; approximately 5-10% are hereditary, with 14% of triple-negative breast cancers (TNBC) harboring BRCA mutations. BRCA1/2 are essential for homologous recombination repair of DNA double-strand breaks, whereas PARP mediates base-excision repair of single-strand breaks. PARP inhibitors (PARPi) exploit synthetic lethality to selectively eliminate BRCA-deficient tumor cells. Olaparib and talazoparib have demonstrated superior PFS and ORR versus chemotherapy in BRCA-mutated, HER2-negative advanced breast cancer, leading to FDA approval. In ovarian cancer, PARPi maintenance improves overall survival, with consistent benefits observed in Asian populations. The domestically developed PARPi fluzoparib, engineered with a trifluoromethyl moiety for enhanced stability and tissue penetration, showed in the phase III FABULOUS trial a median PFS of 6.7 vs 3.0 months and an ORR of 43.6% vs 23.3% compared with chemotherapy in gBRCA-mutated, HER2-negative breast cancer, with manageable safety. Data remain limited in Chinese patients and those with BRCA wild-type disease. This study aims to evaluate the efficacy and safety of fluzoparib maintenance monotherapy in advanced TNBC patients-either BRCA1/2-mutated or wild-type-who have derived clinical benefit from prior platinum-based therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluzoparib Maintenance Until Disease Progression or Intolerable Toxicity | Experimental | Drug: Fluzoparib MonotherapyPatients with advanced triple-negative breast cancer who have achieved at least stable disease (SD) or partial response (PR) after ≥2 prior lines of therapy including a platinum-based regimen will receive fluzoparib 150 mg orally twice daily on days 1-28 of each 28-day cycle. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death. Dose interruptions or reductions (to 100 mg BID or 50 mg BID) are allowed for predefined toxicities. No concurrent anticancer therapy is permitted. Efficacy assessments (CT/MRI) will be performed every 6 weeks (2 cycles) from the first dose. Exploratory biomarkers (PD-L1, TILs, CD4/8, cytokines) will be collected optionally for subgroup analyses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18-75 years (inclusive) at the time of informed consent.
- Histologically confirmed triple-negative breast cancer (TNBC; ER <1%, PR <1%, HER2-negative).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Received ≥2 prior lines of systemic therapy, including a platinum-based regimen (single-agent or combination); must have achieved partial response (PR) or stable disease (SD) during or after that platinum-based treatment.
- Platinum-sensitive disease defined as: Objective response (complete or partial) or stable disease lasting ≥6 months while on platinum-based therapy, or Platinum-free interval (PFI) ≥6 months from the end of the last platinum-containing regimen to documented progression/relapse.
Key exclusion criteria (26 listed)
- Known hypersensitivity to fluzoparib or any of its excipients.
- Prior treatment with any PARP inhibitor.
- Use of strong CYP3A4 inhibitors within 14 days or strong CYP3A4 inducers within 28 days before first dose.
- Wash-out interval <4 weeks from any prior anti-cancer therapy (chemotherapy, radiotherapy, surgery, targeted therapy, immunotherapy) to first dose.
- Planned anti-cancer therapy other than study drug during the trial period.
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 MonotherapyFluzoparib is an oral poly (ADP-ribose) polymerase (PARP) inhibitor supplied as 50 mg capsules. Participants take 150 mg twice daily (total 300 mg/day) on days 1-28 of each 28-day cycle. Doses should be swallowed whole with water, approximately 12 hours apart, at approximately the same times each day. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death. Dose interruptions or reductions (stepwise to 100 mg BID or 50 mg BID) are allowed for haematological or non-haematological toxicities graded ≥3 or as clinically indicated. No concurrent anticancer therapy is permitted during fluzoparib maintenance. | Drug | Fluzoparib Maintenance Until Disease Progression or Intolerable Toxicity |
Primary outcome
Progression-free survival (PFS)
Time frame: From first dose of fluzoparib until disease progression or death, assessed every 6 weeks (2 cycles), up to approximately 12 months
Time from first fluzoparib dose to first radiological disease progression (RECIST 1.1) or death from any cause, whichever occurs first.
5 secondary outcomes
Second progression-free survival (PFS2)
Time frame: From first fluzoparib dose until the above events, assessed every 6 weeks while on study and subsequently, up to approximately 24 months.
Duration of response (DoR)
Time frame: From first CR/PR documentation until progression or death, assessed every 6 weeks while on fluzoparib, up to approximately 24 months.
Disease control rate (DCR)
Time frame: From first dose of fluzoparib until the 6-week tumor assessment, up to approximately 2 months.
Overall survival (OS)
Time frame: From first fluzoparib dose until death, assessed up to approximately 36 months.
Incidence and severity of adverse events (AE)
Time frame: From first fluzoparib dose up to 30 days after last dose, assessed throughout the study and during follow-up, expected up to approximately 36 months.
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 Aug 2026.
- 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.
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 Monotherapy in people with Platinum-sensitive and TNBC, Triple Negative 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 13 inclusion and 26 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 Aug 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 Weipeng Zhao (+86+022-23109106, maoxun1977@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From first dose of fluzoparib until disease progression or death, assessed every 6 weeks (2 cycles), up to approximately 12 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 Aug 2026.