Promising drug combo aims to shrink breast tumors before surgery
NCT ID NCT06144944
First seen Jun 27, 2026 · Last updated Aug 19, 2026 · Updated 2 times
Summary
This study tests whether adding the targeted drug pyrotinib to standard chemotherapy can better shrink tumors before surgery in people with a common type of early breast cancer (HR-positive, HER2-low). About 160 adults with high-risk, early-stage breast cancer will be randomly assigned to receive either the drug combo or chemo alone. The main goal is to see if the combo leads to less cancer remaining in the breast tissue after treatment.
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
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jan 2024
- Expected to finish
-
Dec 2031
An estimate. End dates often move.
- Lead sponsor
-
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
-
17 to 70 years
- Sex
-
Anyone
- 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: * Must participate voluntarily, sign the informed consent form, and have good compliance * Aged ≥ 18 and ≤ 70 years old with ECOG PS score of 0-1 * Histopathological newly diagnosed, unilateral, primary invasive breast cancer * Histopathological hormone receptor-positve ( estrogen receptor and/or progesterone receptor ≥ 10% stained cells) and HER2-low (immunochemistry 2+ with fluorescent in situ hybridization negative) * TNM stage-IIb/III, or TNM stage-IIa with high risk (N+, G3, or MammaPrint High-risk) * At least one evaluable target breast lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Left ventricular ejection fraction ≥ 55%, Fridericia-corrected QT interval \< 450 ms in males and \< 470 ms in females * White blood cell count: ≥ 3.0 × 10\^9/L, absolute neutrophil count: ≥ 1.5 × 10\^9/L, platelet count: ≥ 100 × 10\^9/L, hemoglobin: ≥ 90 g/L * Aspartate aminotransferase and alanine aminotransferase: ≤ 2.5 × ULN, alkaline phosphatase: ≤ 2.5 × ULN, blood total bilirubin: ≤ 1.5 × ULN, serum creatinine: ≤ 1.5 × ULN * Non-menopausal or non-surgically sterilized female patients identified as non-pregnant and non-lactating and consented to contraception both during the trial and within 6 months after the last administration of the test drug Exclusion Criteria: * Metastatic BC, bilateral BC, occult BC, inflammatory BC, or with other malignant tumors * Known history of hypersensitivity to the study drugs * Patients who need receive other anti-tumor treatments (except for OFS) during neoadjuvant therapy as judged by the investigators * With severe cardiac disease or discomfort that is not expected to tolerate treatment, including but not limited to: a) arrhythmia that requires medication or is clinically significant, or high-grade atrioventricular block, b) unstable angina, myocardial infarction, heart failure or clinically significant heart valve disease, c) poorly controlled hypertension or any heart disease unsuitable for participation in this trial as determined by the investigators * Patients who participated in a clinical trial of another drug within 4 weeks prior to randomization or underwent BC-free surgery within 4 weeks or had not fully recovered after BC-free surgery * Other malignancy in the past 5 years, other than cured cervical carcinoma in situ, basal or squamous cell carcinoma of skin * Patients who had basic gastrointestinal diseases (especially long-term history of diarrhea or/and constipation), inability to swallow, intestinal obstruction or other factors will affect drugs administration and absorption * Presence of accompanying diseases that may pose serious risks to the safety of the patient or may affect the patient's ability to complete the study (including but not limited to severe diabetes mellitus, active infection, thyroid disorders, etc.) as judged by the investigator * With a history of immunodeficiency, including acquired or congenital immunodeficiencies, or a history of organ transplantation * Past history of confirmed neurological or mental disorders, including epilepsy or dementia * Other conditions of the subject determined by the investigator to be unsuitable for the study
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer invasive are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510120, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can breast radiation be compressed to one week without hurting cosmetic results?
- Can an oral HER2 drug boost Chemo's punch in HER2-Low breast cancer?
- Breast Cancer's genetic fingerprint: a new platform aims to match tumors to targeted trials
- Zapping a few growing tumors may keep breast cancer drugs working longer
- Can breast radiation be cut from three weeks to one?
- Can a new drug combo outsmart breast cancer that resists current therapy?