New hope for aggressive breast cancer: drug combo aims to wipe out tumors before surgery
NCT ID NCT06618014
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the immunotherapy drug toripalimab to standard chemotherapy before surgery can completely eliminate tumors in people with localized triple-negative breast cancer. About 51 women with early-stage, untreated disease will receive the combination, then have surgery to check for remaining cancer. The goal is to see if this approach improves the chance of having no cancer left at the time of surgery.
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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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51 people
The number who actually took part.
- Started
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Jan 2022
- Expected to finish
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Dec 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 69 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: * Pathologically confirmed TNBC. ER and PR negatives are defined as \< 10% of cells expressing hormone receptors by IHC analysis. HER2 negative is defined as IHC 0 or 1+, or ISH-negative. * Treatment-naive clinical stage T1-4N1-N3 or T2-4N0 localized TNBC. * Female patients aged ≥18 years, \< 70 years. * Able to comply with the required protocol and follow-up procedures. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Life expectancy ≥12 weeks. * Adequate hematological function: Absolute neutrophil count (ANC) ≥1.5 x 109/L, and Platelet count ≥90 x 109/L, and Hemoglobin ≥90 g/L (may be transfused to maintain or exceed this level). * Adequate liver function: Total bilirubin ≤ 1.5 x upper limit of normal (ULN), Aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 1.5 x ULN. * Adequate renal function: Serum creatinine ≤ 1.5 x ULN, and creatinine clearance ≥ 50 ml/min. * Subjects should not be pregnant or breast-feeding. Exclusion Criteria: * Inflammatory breast cancer or stage IV breast cancer. * Prior systemic antitumor treatment for any malignancy, including chemotherapy, radiotherapy, immunotherapy and targeted therapy. * History of another malignancy in the last 5 years with the exception of the following: other malignancies cured by surgery alone and having a continuous disease-free interval of 5 years are permitted. Cured basal cell carcinoma of the skin and cured in situ carcinoma of the uterine cervix are permitted. * Inability to comply with protocol or study procedures. * Subjects with active, known or suspected autoimmune disease. Subjects in conditions not expected to recur in the absence of an external trigger, or not requiring systemic treatment are permitted to enroll. * Previous history of interstitial lung disease/pneumonia. * Patient who has had an allogeneic tissue/solid organ transplant. * A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study. * A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease. * Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). * Patient who has active serious infection (e.g. pyrexia of or 38.0℃ over) * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). * Women who are pregnant or nursing.
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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.
Contacts and locations
Locations
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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