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New PET scan could predict which breast cancer patients respond to targeted therapy

NCT ID NCT02827877

Diagnosis Sponsor: City of Hope Medical Center 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial is testing whether a special PET scan using copper Cu64-DOTA-trastuzumab can predict how well HER2-positive breast cancer responds to trastuzumab and pertuzumab before surgery. The study involves 18 women with locally advanced HER2-positive breast cancer. The goal is to see if the scan can identify who will have a complete response, potentially guiding more personalized treatment.

What this could mean

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

Active substance
Copper Cu 64-DOTA-Trastuzumab (a radioactive tracer for PET imaging)
What this could lead to
If successful, this imaging method could help doctors quickly identify which patients will benefit from trastuzumab and pertuzumab, avoiding ineffective treatments.
What could go wrong
This is a small early-phase study with only 18 participants, so results may not apply to all patients. The imaging technique may not accurately predict response in everyone.

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

18 people

The number who actually took part.

Started

Jul 2016

Expected to finish

Sep 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 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Participants must be women who have histological confirmation of HER2 positive breast cancer * The primary tumor must be \>= 2.0cm in size and/or have biopsy proven axillary nodes that are \>= 2.0cm in size by mammography, ultrasound, or magnetic resonance imaging (MRI) * The current cancer must over express HER2 as determined by immunohistochemistry (IHC) and/or fluorescence in situ hybridization (FISH) * Patients may not have received prior HER2 directed therapies * Participants must have normal cardiac ejection fraction (per label, as defined as institutional normal) * Planned neoadjuvant therapy with six cycles of combined pertuzumab, trastuzumab and chemotherapy * Ability to provide informed consent * Negative Serum Pregnancy test Exclusion Criteria: * Participants who are not considered candidates for pertuzumab + trastuzumab + chemotherapy * Concurrent malignancy other than non-melanoma skin cancer * Patients must not have known metastatic disease * Patients must not have received prior treatment for the current breast cancer

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

HER2-positive breast carcinoma Stage IIIA breast cancer Stage IIIB breast cancer Stage IIIC breast cancer

Contacts and locations

Locations

  • City of Hope Medical Center

    Duarte, California, 91010, United States

More trials for these conditions

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