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New drug cocktail aims to wipe out breast cancer before surgery

NCT ID NCT04126525

Disease control Sponsor: RenJi Hospital Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial is testing whether adding the targeted drug pyrotinib to standard chemotherapy and trastuzumab before surgery can eliminate more cancer in women with HER2-positive early breast cancer. About 53 participants will receive the combination, and the main goal is to see how many have no cancer left at the time of surgery. The study is active but no longer recruiting.

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 drug) combined with trastuzumab, paclitaxel, and cisplatin
What this could lead to
If successful, this could offer a more effective pre-surgery treatment for HER2-positive breast cancer, potentially increasing the chance of no cancer remaining at surgery.
What could go wrong
This is a small, early-phase trial with only 53 participants. Results may not apply to all patients, and side effects from the drug combination could be significant.

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

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

53 people

The number who actually took part.

Started

Jun 2019

Expected to finish

Nov 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: * Female, Aged ≥18 and ≤70 years * Histologically confirmed invasive HER2 positive breast cancer, early disease(Stage ⅡA-Ⅲ) * Subjects with at least one evaluable lesion * ECOG 0-1 * Adequate organ function Exclusion Criteria: * Metastatic disease (Stage IV) * Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption * Treated or treating with T-DM1, lapatinib and neratinib before study entry * History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation * Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial * Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test. Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period * Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study

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Conditions

The condition(s) this trial relates to.

female breast carcinoma HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer female

Contacts and locations

Locations

  • Renji Hospital

    Shanghai, China

More trials for these conditions

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