New pill aims to keep advanced breast cancer at bay
NCT ID NCT07321015
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 1 time
Summary
This phase 2 study is testing fluzoparib, a daily pill, as a maintenance therapy for people with advanced triple-negative breast cancer whose disease was controlled by platinum chemotherapy. The trial will enroll 72 participants with or without BRCA gene mutations. The goal is to see how long the drug can delay cancer progression and how safe it is.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Fluzoparib (a PARP inhibitor taken as a capsule)
- What this could lead to
- If successful, fluzoparib could offer a new maintenance option to delay cancer progression in patients with advanced triple-negative breast cancer, especially those with BRCA mutations.
- What could go wrong
- This is a small, early-phase study (72 participants) with no comparison group, so results may not be definitive. Side effects like low blood counts are possible, and the drug may not work for everyone, particularly those without BRCA mutations.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 72 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18-75 years (inclusive) at the time of informed consent. 2. Histologically confirmed triple-negative breast cancer (TNBC; ER \<1%, PR \<1%, HER2-negative). 3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. 4. 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. 5. 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. 6. Estimated life expectancy ≥3 months. 7. At least one measurable lesion per RECIST 1.1 on CT/MRI; evidence of metastatic disease (soft-tissue and/or bone lesions) is required. 8. Willing to provide archived tumour tissue (core biopsy or excision) or fresh biopsy/blood for biomarker analyses. 9. 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 10. 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). 11. 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. 12. Signed written informed consent prior to any study-specific procedures. Exclusion Criteria: 1. Known hypersensitivity to fluzoparib or any of its excipients. 2. Prior treatment with any PARP inhibitor. 3. Use of strong CYP3A4 inhibitors within 14 days or strong CYP3A4 inducers within 28 days before first dose. 4. Wash-out interval \<4 weeks from any prior anti-cancer therapy (chemotherapy, radiotherapy, surgery, targeted therapy, immunotherapy) to first dose. 5. Planned anti-cancer therapy other than study drug during the trial period. 6. Severe bone complications from bone metastases (uncontrolled pain, impending pathological fracture, or spinal cord compression within 6 months or judged likely to occur). 7. 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.) 8. Active autoimmune disease requiring systemic therapy within the past 2 years. 9. Recovery from major surgery under general anesthesia or severe trauma \<14 days before start of study treatment. 10. Active hepatitis B (HBsAg positive and HBV DNA ≥500 IU/mL) or hepatitis C (anti-HCV positive and HCV RNA \>ULN). 11. Untreated CNS metastases. 12. History of immunodeficiency (including HIV positive), congenital or acquired, or prior solid-organ transplant. 13. Other malignancies within 5 years except adequately treated carcinoma in situ or indolent tumors judged by the investigator to have low risk of recurrence. 14. 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. 15. History of non-infectious pneumonitis requiring steroids or current pneumonitis. 16. Clinically significant ECG abnormalities, including QTcF \>470 ms in females (QTc calculated with Fredericia's formula). 17. 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). 18. Active infection or unexplained fever \>38.5 °C on screening or day 1 (tumor fever allowed if investigator judges stable). 19. Uncontrolled chronic systemic diseases (severe pulmonary, hepatic, renal, or cardiac). 20. Thyroid function abnormalities (TSH, FT3, FT4) deemed clinically significant by the investigator. 21. 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. 22. Urinalysis ≥++ proteinuria confirmed by 24-h urine protein \>1.0 g. 23. Arterial or venous thrombo-embolic events (stroke, TIA, DVT, PE) within 6 months before screening. 24. Active tuberculosis or acute infection requiring anti-infective therapy. 25. Live-vaccine administration within 30 days before planned first dose. 26. 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University Cancer Institute and Hospital
RECRUITINGTianjin, China
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Other studies related to the condition(s) this trial covers.
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- Could a vaccine stop Triple-Negative breast cancer from coming back?
- Engineered immune cells take aim at Mesothelin-Positive tumors