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New imaging tracer could sharpen detection of aggressive breast cancer

NCT ID NCT01093612

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 pilot study tests a special PET scan using a radioactive tracer called 64Cu-DOTA-trastuzumab in 18 women with advanced HER2-positive breast cancer. The goal is to see if this scan can better identify HER2-positive tumors compared to standard imaging. If it works, it may help doctors choose more targeted treatments for each patient.

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 scans)
What this could lead to
If successful, this imaging method could help doctors more accurately identify HER2-positive tumors and plan better treatments for advanced breast cancer.
What could go wrong
This is a very small pilot study with only 18 participants, so results may not apply to all patients. The technique is still experimental and not yet proven to improve outcomes.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

18 people

The number who actually took part.

Started

Mar 2011

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

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.

Eligibility Part I (Determination of the cold dose) * Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible). * At least 1 non-hepatic site of metastasis greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied. * The cancer must over express HER2 as determined by IHC and FISH. * Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months. * Participants must have normal cardiac ejection fraction. Eligibility Part 2 (correlation of HER2 expression with PET uptake) * Participants must be women who have histological confirmation of metastatic invasive breast cancer that has metastasized outside the region of the primary tumor and axilla. Biopsy must be obtained within 28 days prior to study. Patients must have metastatic disease in lung, liver, soft-tissue or bone to qualify for the study (more than one site is permissible). * At least 1 non-hepatic site of metastasis site greater than or equal to 2 cm in mean diameter must be identified in addition to the site that was biopsied. * Participants with HER2 1+, 2+ and 3+ by IHC are eligible. * Patients may have received trastuzumab in the adjuvant, neoadjuvant, or metastatic setting, but cannot have received the drug within the prior 2 months. * Participants must have normal cardiac ejection fraction. Ineligibility * Participants who have received trastuzumab within the prior 2 months * Participants who are not considered candidates for trastuzumab * Metastatic disease in a single site * No metastatic site greater than or equal to 2 cm * Concurrent malignancy other than skin cancer * Inability to provide informed consent * Participants who are pregnant

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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 Stage IV breast cancer

Contacts and locations

Locations

  • City of Hope

    Duarte, California, 91010, United States

More trials for these conditions

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