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New pill combo aims to wipe out breast tumors before surgery

NCT ID NCT04290793

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

Mar 2020

Expected to finish

Dec 2026

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

18 to 70 years

Sex

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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.