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Could a gentler chemo cocktail beat breast cancer with fewer side effects?

NCT ID NCT07421141

Disease control Sponsor: National Medical Research Radiological Centre of the Ministry of Health of Russia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase II trial is testing a less intense chemotherapy regimen for people with early-stage HER2-positive breast cancer. The experimental treatment combines paclitaxel with two targeted drugs (trastuzumab and pertuzumab), skipping the harsher anthracycline drugs. Researchers want to see if this gentler approach can still eliminate all signs of cancer before surgery, while causing fewer side effects. The study includes 186 participants and compares results to a historical group that received standard chemo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Paclitaxel, trastuzumab, and pertuzumab (THP)
What this could lead to
If successful, this could offer a less toxic chemotherapy option for early HER2-positive breast cancer, reducing side effects while maintaining high cure rates.
What could go wrong
This is a phase II study with only 186 participants, so results are preliminary. The experimental regimen may prove less effective than standard treatment, and long-term outcomes are not yet known.

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

186 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Dec 2028

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 75 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: * Histologically confirmed invasive breast carcinoma. * HER2-positive status defined as IHC 3+ or FISH amplification (ratio \>= 2.0). * Clinical Stage IIA-IIB (cT1-T2 N0-N1, cT3 N0, M0). * Operable disease planned for surgical resection. * ECOG performance status 0-1. * Left Ventricular Ejection Fraction (LVEF) \>= 50% by Echocardiography. * Adequate bone marrow, hepatic, and renal function. * Signed informed consent form. Exclusion Criteria: * Metastatic disease (Stage IV). * Prior systemic therapy for breast cancer (chemotherapy, immunotherapy, or anti-HER2 therapy). * Serious cardiac history (congestive heart failure, unstable angina, myocardial infarction within 6 months). * Other synchronous or metachronous malignancies within 5 years (except non-melanoma skin cancer or carcinoma in situ of the cervix). * Pregnancy or breastfeeding. * Known hypersensitivity to study drugs.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer Early breast cancer HER2-positive breast cancer

Contacts and locations

Locations

  • P.A. Hertsen Moscow Oncology Research Institute

    Moscow, 125284, Russia

More trials for these conditions

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