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Could six months of targeted therapy be enough for some breast cancer patients?

NCT ID NCT04928261

Disease control Sponsor: Ottawa Hospital Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looks at whether patients with early-stage HER2-positive breast cancer who have a complete response to initial chemotherapy and HER2-targeted therapy can safely receive only 6 months of further HER2 treatment instead of the standard 12 months. The goal is to reduce heart side effects and treatment burden while maintaining effectiveness. The trial will enroll 52 participants across multiple Canadian centers.

What this could mean

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

Active substance
Trastuzumab (Herceptin)
What this could lead to
If successful, this could show that a shorter course of HER2-targeted therapy is safe and effective for patients who have a complete response to initial treatment, reducing heart risks and treatment burden.
What could go wrong
This is a small, single-arm study with only 52 participants, so results may not apply broadly. Shorter therapy might increase the risk of cancer recurrence, and heart side effects remain a concern.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

52 people

The number who actually took part.

Started

Dec 2021

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 years and older

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: * Early-stage (I-III, i.e. non-metastatic) as per AJCC 8th edition, ER/PR positive or negative, HER2-positive as per 2018 American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines. * Treated with neoadjuvant chemotherapy and HER2 targeted therapy preoperatively with a pathological complete response (pCR) defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy at surgery. Must have received less than 6 months of HER2 targeted therapy * Able to provide verbal consent and complete questionnaires in English or French Exclusion Criteria: * Residual invasive disease following neoadjuvant therapy, or metastatic disease * Contraindication to further HER2-targeted therapy following completion of neoadjuvant treatment * Any psychological, familial, sociological or geographical condition potentially hampering compliance with the trial protocol

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Cardiotoxicity HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H8M2, Canada

More trials for these conditions

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