Not Yet RecruitingPhase 2

Retlirafusp Alfa Combined With Chemotherapy or Fuzuloparib for Triple-Negative Breast Cancer

China120 participantsStarted 2026-07-30

Plain-language summary

To investigate the efficacy and safety of Retlirafusp alfa in combination with chemotherapy or fluzoparib for early-stage and advanced triple-negative breast cancer.

Who can participate

Age range

18 Years – 100 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Age ≥18 years, female;
. Histopathologically confirmed recurrent or metastatic triple-negative breast cancer, defined as ER-negative (IHC ER-positive percentage \<1%), PR-negative (IHC PR-positive percentage \<1%), and HER2-negative (IHC -/+ or IHC ++ but FISH/CISH -);
. At least one measurable lesion per RECIST version 1.1 criteria;
. Advanced cohort:
. Life expectancy ≥3 months;
. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
. Available tissue sample for testing, and gBRCA1/2 mutation status must be determined prior to treatment;
. Adequate major organ function meeting the following criteria (no blood transfusion or use of granulocyte colony-stimulating factor or thrombopoietin within 2 weeks prior to screening):

Exclusion criteria

. Concurrently receiving anti-tumor therapy in another clinical trial;
. Received other anti-tumor therapy within 4 weeks prior to the first dose of study drug;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Late-Stage Cohort-Objective Response Rate

Timeframe: Assessed every 6 weeks (every 2 cycles) during treatment until disease progression, death, or loss to follow-up. Analysis cutoff at 6 months.

Neoadjuvant Cohort-tpCR (ypT0/is ypN0)

Timeframe: Surgery performed 2-6 weeks after completing 8 cycles (≈24 weeks) of neoadjuvant therapy; pathological assessment post-surgery. Analysis cutoff at 6 months.

Trial details

NCT IDNCT07752550

SponsorHarbin Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-07-30

Contact for this trial

Tong Liu, M.D.

+8615945953777 liutong@hrbmu.edu.cn

View on ClinicalTrials.gov More Triple-Negative Breast Cancer (TNBC) trials