Can an oral HER2 drug boost Chemo's punch in HER2-Low breast cancer?
NCT ID NCT05165225
First seen Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time
Summary
Researchers are testing whether adding pyrotinib, an oral drug that targets HER2-family proteins, to standard chemotherapy helps shrink HER2-low, hormone receptor-positive breast cancer before surgery. The trial enrolls about 48 women with early or locally advanced disease. Everyone receives pyrotinib plus epirubicin, cyclophosphamide, and docetaxel, and doctors measure how much cancer remains in the breast and lymph nodes after treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pyrotinib, an oral drug that blocks HER2-family signals, added to standard chemotherapy drugs epirubicin, cyclophosphamide, and docetaxel
- What this could lead to
- If it works, this could offer a new presurgical option for HER2-low, hormone receptor-positive breast cancer, a group that often responds less well to standard chemotherapy alone.
- What could go wrong
- This is a small, single-arm phase 2 trial with no comparison group, so any benefit is hard to attribute to pyrotinib specifically. Pyrotinib can cause diarrhea and other side effects, and results may not hold in larger, randomized studies.
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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 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2021
- Expected to finish
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Mar 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. Written informed consent for all study according to local regulatory requirements prior to beginning specific protocol procedures 2. Female patients, age ≥ 18 years 3. Histologically confirmed unilateral primary carcinoma of the breast, except for occult breast cancer, inflammatory breast cancer without assessable focus or eczema like breast cancer 4. HER2-low-positive (defined here as HER2 IHC 2+ and FISH-) and HR positive(defined here as ER and/or PR \>1% stained cells) 5. Tumour greater than 2 cm diameter or histologically (core- or fine-needle biopsy) involved lymph nodes 6. According to RECIST version 1.1, there is at least one evaluable target lesion 7. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1 8. Required laboratory values including following parameters: WBC count:≥3.0 x 10\^9/L ; ANC: ≥ 1.5 x 10\^9/L; Platelet count: ≥ 100 x 10\^9/L; Hemoglobin: ≥ 9.0 g/dL; Total bilirubin: ≤ 1.5 x upper limit of normal (ULN); ALT and AST: ≤ 2.5 x ULN; alkaline phosphatase ≤ 2.5 × ULN; Serum creatinine: ≤ 1.5 × ULN; Left ventricular ejection fraction (LVEF) ≥ 55% 9. For female patients without menopause or surgical sterilization: consent to contraception both during the trial and within 6 months after the last administration of the test drug Exclusion Criteria: 1. Metastatic disease (Stage IV) or bilateral breast cancer 2. Known history of hypersensitivity to pyrotinib or any of it components 3. According to the judgment of the researcher, other anti-tumor treatments (except for ovarian function inhibitors) are required during neoadjuvant therapy 4. Patients with severe heart disease or discomfort who are expected to be unable to tolerate chemotherapy, including but not limited to these: 1). Fatal arrhythmia or higher grade atrioventricular block (second degree type 2 atrioventricular block or third degree atrioventricular block) 2). Unstable angina pectoris 3). Heart valve disease with clinical significance 4). ECG showed transmural myocardial infarction pain 5). Poor control of hypertension 5. Patients underwent major breast cancer-free surgery within 4 weeks or have not fully recovered 6. Serious or uncontrolled infections that may affect study treatment or evaluation of study results, including but not limited to active hepatitis virus infection, human immunodeficiency virus (HIV) antibody positive, lung infection, etc 7. History of other malignant tumors in the past 5 years (excluding cured carcinoma in situ of cervix or skin basal cell carcinoma) 8. Those with basic gastrointestinal diseases (especially long-term history of diarrhea or/and constipation);Inability to swallow、intestinal obstruction or other factors will affect drug administration and absorption 9. The investigator believes that the patient has any other conditions that are not suitable for participation in the study
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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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