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Promising drug combo aims to shrink breast tumors before surgery

NCT ID NCT06144944

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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

  • 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.