New drug combo shows promise for Hard-to-Treat breast cancer
NCT ID NCT04872985
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding the drug pyrotinib to standard chemotherapy before surgery can improve outcomes for women with stage II to III hormone receptor-positive, HER2-negative breast cancer that also has high levels of the HER4 protein. About 140 participants will receive either pyrotinib or a placebo alongside chemotherapy, and researchers will measure how much cancer remains after treatment. The goal is to see if this combination leads to a better response and fewer cancer cells left behind.
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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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About 140 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2021
- 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 75 years
- Sex
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Anyone
- 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: * Presenting with histological(by core needle biopsy or by limited incisional biopsy) proven hormone receptor positive (ER≥10% and/or PR ≥1%), HER2 negative(IHC ≤2+ and/or FISH-) , stage II/ III breast cancer. * Have clinical indication for neoadjuvant therapy. * HER4 IHC score ≥ 4. * Measurable disease (breast and/or lymph nodes). * The Eastern Cooperative Oncology Group (ECOG) performance status must be 0 or 1. * Adequate bone marrow function (within 4 weeks prior to registration): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l. * Adequate liver function (within 4 weeks prior to registration): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL. * Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be ≥50 ml/min. * Patients must have the ability to swallow oral medication. * Without history of any kind of treatment to known malignancy (solid tumor or hematologic). * Written informed consent. * Accessible for treatment and follow-up. Exclusion Criteria: * Evidence of stage IV breast cancer. * Contralateral invasive breast cancer or Inflammatory breast cancer. * History of non-breast malignancies (except for in situ cervical cancers, basal cell carcinoma of the skin, squamous cell carcinomas of the skin or thyroid papillary carcinoma that had received curative treatment before enrollment) within 5 years prior to randomization. * Known metastatic disease from any malignancy (solid tumor or hematologic). * Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate \<50 at rest) or QTcF ≥450 msec. * Known hypersensitivity reaction to any of the components of the treatment. * Pregnancy or lactation at the time of randomization. * Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.
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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 Memorial Hospital of Sun-Yat-Sen University
Guangzhou, Guangdong, 510120, China
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Other studies related to the condition(s) this trial covers.
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