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New combo therapy may help women with early breast cancer avoid mastectomy

NCT ID NCT06843681

What the study statuses mean

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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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 giving two drugs (trastuzumab and a taxane) before surgery can shrink HER2-positive breast carcinoma in situ tumors enough to allow breast-conserving surgery instead of mastectomy. About 54 women aged 18-70 with tumors at least 2 cm will receive 4-6 cycles of treatment. The main goal is to see how many can have breast-conserving surgery after therapy.

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

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Jan 2030

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. Diagnosed breast carcinoma in situ (female, 18 to 70 years old); 2. Breast mass ≥2cm, and in situ cancer pathology confirmed HER2 positive (definition: immunohistochemical results 3+ or in situ hybridization results positive); 3. No evidence of distant transfer; 4. Have not received any previous cancer treatment; 5. Imaging examination showed at least one measurable lesion within 2 weeks before enrollment; 6. Left ventricular ejection fraction (LVEF) was measured by echocardiography ≥50%; 7. Previous treatment-related toxicity should be alleviated to NCI CTCAE (version 5.0) ≤1 degree, AST and ALT≤2.5 times the upper limit of normal, total bilirubin ≤1.5 times the upper limit of normal; 8. Liver and kidney function tests are basically normal: 1. Total bilirubin (TBIL) ≤3× upper limit of normal (ULN), 2. Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤2.5×ULN (patients with liver metastasis ≤5xULN), 3. Serum creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥60 ml/min; 9. Adequate bone marrow functional reserve: 1. White blood cell count (WBC) ≥3.0×10\^9 / L, 2. Neutrophil count (ANC) ≥1.5×10\^9 / L, 3. Platelet count (PLT) ≥70×10\^9 / L 10. Fertile women must use contraceptives; 11. Be able to understand the research process, voluntarily participate in the study, and sign the informed consent. Exclusion Criteria: 1. Metastatic breast cancer (stage IV); 2. History of invasive breast cancer, or prior systemic treatment to treat or prevent breast cancer; 3. Previous or concurrent malignant diseases, except skin basal cell carcinoma or cervical cancer in situ; 4. Patients with severe heart disease or discomfort that is not expected to tolerate chemotherapy, including but not limited to: fatal arrhythmias or higher grade atrioventricular block, unstable angina pectoris, clinically significant valvular disease, transmural myocardial infarction shown by electrocardiogram, uncontrolled hypertension; 5. Insufficient bone marrow or kidney function, liver function impairment; 6. Grade 2 or more severe peripheral neuropathy; 7. Patients with thrombocytopenia, neutropenia, anemia, hypokalemia, and elevation of alanine aminotransferase or aspartate aminotransferase above CTCAE Level 1; 8. Patients who are known to be allergic to the active ingredient or other ingredient of the investigational drug; 9. Had received radiotherapy, chemotherapy, endocrine therapy, or was participating in any interventional drug clinical trial within 4 weeks prior to enrollment; 10. Pregnant or lactating women, women of childbearing age who refused to use effective contraception during the study period; 11. Any other conditions that the investigator considers the patient unfit to participate in the study, concomitant diseases or conditions that may interfere with study participation, or any serious medical disorder that may affect the safety of the subject (e.g., uncontrolled heart disease, high blood pressure, active or uncontrollable infection, active hepatitis B virus infection).

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, China

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