New cocktail of drugs aims to wipe out aggressive breast cancer before surgery
NCT ID NCT07187674
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early study tests a combination of two immunotherapy drugs (iparomlimab and tuvonralimab), a targeted therapy (olaparib), and chemotherapy (paclitaxel) given before surgery to 20 women with early, high-risk triple negative breast cancer that has a specific DNA repair defect (HRD positive). The goal is to see if this approach can eliminate all cancer cells in the breast and lymph nodes by the time of surgery. The study is exploratory and will also monitor safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- iparomlimab, tuvonralimab, olaparib, and paclitaxel
- What this could lead to
- If successful, this could point toward a more effective pre-surgery treatment for a hard-to-treat breast cancer type, potentially improving the chance of no cancer remaining after surgery.
- What could go wrong
- This is a very early, small study with only 20 participants, so results may not apply broadly. The combination of drugs may cause significant side effects, and it is not yet known if it works better than standard care.
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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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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 70 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. Voluntarily join this study and sign an informed consent form; 2. Women aged ≥ 18 years and ≤ 70 years with early breast cancer:According to the definition of the latest ASCO/CAP guidelines, triple negative breast cancer patients with T1cN1-2 or T2-4N0-2 stage confirmed by histopathology; 3. Subjects with HRD positive tumor tissue evaluation; 4. According to RECIST 1.1, there must be at least one measurable lesion; 5. ECOG score: 0 to 1; 6. Tumor tissue specimens that can be used for biomarker detection; 7. The function of important organs meets the following requirements (no blood components or cell growth factor drugs are allowed to be used within 14 days before the first medication): Absolute neutrophil count ≥ 1.5 × 10\^9/L; Platelets ≥ 100 × 10\^9/L; Hemoglobin ≥ 90 g/L; Serum albumin ≥ 30 g/L; Thyroid stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be examined simultaneously. If FT3 and FT4 levels are normal, they can be included in the group); Serum total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; AKP≤ 2.5×ULN; Serum creatinine ≤ 1.5 × ULN; 8. Female patients with non-surgical sterilization or childbearing age need to use a medically approved contraceptive measure (such as intrauterine device, contraceptive pill or condom) during the study treatment period and within 3 months after the end of the study treatment period; ; And must be non lactation; For male patients whose partners are women of childbearing age, effective methods of contraception should be used during the trial and within 3 months after the last administration of trial drugs. Exclusion Criteria: 1. There is any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo or asthma in childhood have been completely relieved and do not need any intervention after adulthood can be included; asthma requiring medical intervention with bronchodilators cannot be included); 2. Currently using immunosuppressants or systemic hormone therapy for immunosuppression (with a dosage of \>10mg/day of prednisone or other equally effective hormones), and still continuing to use them within 2 weeks prior to enrollment; 3. Severe allergic reaction to other monoclonal antibodies; 4. Known history or evidence of interstitial lung disease or active non infectious pneumonia; 5. Having other malignant tumors in the past 5 years or at the same time (except for cured skin basal cell carcinoma and cervical carcinoma in situ); 6. Have hypertension and can not be well controlled after antihypertensive drug treatment; Had hypertension crisis or hypertensive encephalopathy in the past; 7. There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within 1 year (4) clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention (5) qtc\>450ms (male); Qtc\>470ms (female); 8. The urine routine showed that the urine protein was ≥ + +, and the 24-hour urine protein volume was confirmed to be \>1.0 g; 9. Patients with active infection, unexplained fever ≥ 38.5 ℃ within 7 days before medication, or white blood cell count \>15 × 10\^9/l at baseline; 10. Have congenital or acquired immune deficiency (such as HIV infected persons); Hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 iu/ml, or hepatitis C virus antibody positive; 11. Less than 4 weeks before the study medication or may be vaccinated with live vaccines during the study period; 12. Bilateral breast cancer; 13. According to the judgment of the investigator, the patient has other factors that may affect the results of the study or cause the forced termination of the study, such as alcohol abuse, drug abuse, other serious diseases (including mental illness) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the patient.
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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
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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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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