New pill combo aims to wipe out breast tumors before surgery
NCT ID NCT04290793
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the targeted drug pyrotinib to standard chemotherapy and trastuzumab can completely eliminate HER2-positive breast tumors before surgery. About 113 women with early-stage HER2+ breast cancer will receive the combination, then have surgery to check for any remaining cancer. The goal is to see if this approach improves the chance of a complete response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Pyrotinib (a targeted cancer pill) combined with chemotherapy drugs (epirubicin, cyclophosphamide, docetaxel) and trastuzumab (a targeted antibody)
- What this could lead to
- If successful, this combination could become a new standard neoadjuvant treatment to shrink or eliminate HER2-positive breast tumors before surgery, potentially reducing recurrence risk.
- What could go wrong
- This is a single-arm phase 2/3 trial with no comparison group, so results are preliminary. Side effects from the drug combination may be significant, and the regimen may not outperform existing therapies.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
-
About 113 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2020
- Expected to finish
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Dec 2026
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
-
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. Female breast cancer patients at the age of \>= 18 years and \<= 70 years who received first treatment; 2. Pathologically confirmed HER2-positive invasive breast cancer(which is defined as the immunohistochemistry score of \> 10% immunoreactive cells being 3+ or in situ hybridization results showing HER2 gene amplification),regardless of hormone receptor status (ER and PR); 3. According to the 2019 CSCO BC guidelines: When HER-2 positive is used as the standard for preoperative neoadjuvant therapy for breast cancer, the tumor is larger than 2 cm; 4. The Eastern Tumor Collaborative Group (ECOG) has a physical status score of ≤1; 5. The functional level of the main organs must meet the following requirements : 1) blood routine test: hemoglobin (Hb) ≥ 90g/L;Neutrophils (ANC) ≥ 1.5 × 10\^9/L; platelet count (PLT) ≥ 90 × 10\^9/L; 2) Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; Urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; 3) Heart color ultrasound: Left ventricular ejection fraction (LVEF) ≥ 55%; 6. Women of childbearing age, tested negative for serum pregnancy test 7 days before randomization,and willing to use appropriate methods during the trial and within 8 weeks after the last administration of the test drug; 7. A volunteer to participate in the study; provision of written informed consent; good compliance and willing to cooperate during the follow-up. Exclusion Criteria: 1. Known history of hypersensitivity to pyrotinib or any of it components; 2. Patients have previously received antitumor treatment or radiation therapy for any malignant tumor (except for cervical carcinoma in situ and basal cell carcinoma that have been cured); 3. Patients underwent major breast cancer-free surgery within 4 weeks and have not fully recovered; 4. Subjects that are unable to swallow tablets,intestinal obstruction or dysfunction of gastrointestinal absorption; 5. Patients with severe heart disease or discomfort who cannot be treated; 6. The patient suffers from mental illness or psychotropic substance abuse and cannot cooperate; 7. Pregnant or lactating women; 8. Less than 4 weeks from the last clinical trial; 9. Patients participating in other clinical trials at the same time 10. The researchers think inappropriate.
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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
-
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
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Other studies related to the condition(s) this trial covers.
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