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PET scans could guide smarter breast cancer therapy

NCT ID NCT07527806

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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a special PET scan (HER2-PET) can help doctors personalize treatment for early-stage HER2-positive breast cancer. After two cycles of standard therapy, the scan results will determine if patients need stronger or milder treatment. The goal is to improve the chance of eliminating the cancer before surgery while avoiding unnecessary side effects. About 156 participants will be enrolled.

What this could mean

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

Active substance
Trastuzumab, Pertuzumab, Docetaxel, Nab-paclitaxel, Carboplatin, CDK4/6 inhibitor
What this could lead to
If successful, this could lead to a more personalized treatment approach for HER2-positive breast cancer, potentially improving cure rates and reducing unnecessary side effects.
What could go wrong
This is a Phase 2 trial with only 156 participants, so results may not apply to all patients. The imaging technique is experimental, and the treatment adjustments may not improve outcomes or could cause unexpected side effects.

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 156 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

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: * Voluntary participation with written informed consent obtained prior to any study-related procedures * Age ≥ 18 years, male or female. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Histologically confirmed HER2-positive (IHC 3+, or IHC 2+ with ISH amplification) stage I-III (cT1-3/cN0-2) breast cancer * Tumor diameter ≥ 1.5 cm assessed by imaging, with at least one PET-evaluable lesion present * Patient must have known estrogen receptor (ER) and progesterone receptor (PR) status. For Arm B, ER expression ≥ 10% and must be strongly positive. * Adequate bone marrow, liver, and renal function: WBC \> 3.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, Hb ≥ 10.0 g/dL; total bilirubin ≤ ULN (excluding Gilbert's syndrome), ALP ≤ 2.5 × ULN, AST/ALT ≤ 1.5 × ULN; creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL/min. * Patients who participate in the trial have good compliance and are willing to comply with the follow-up visit. Exclusion Criteria: * Prior treatment with any chemotherapy, anti-HER2 therapy, radiotherapy, or endocrine therapy, etc * Locally advanced (cT4/cN3) or bilateral breast cancer * Patients with known allergies to any active ingredients or excipients of investigational medicinal product * Other malignancy diagnosed within 5 years prior to enrollment, excluding cervical carcinoma in situ and cured melanoma skin cancer * Left ventricular ejection fraction (LVEF) \< 55% * Uncontrolled hypertension (systolic \> 150 mm Hg and/or diastolic \> 100 mm Hg) * Severely cardiovascular disease * Current known infection with HIV, hepatitis B virus, or hepatitis C virus * Patients with pulmonary disease requiring continuous oxygen therapy, previous history of bleeding diathesis or patient is currently receiving anti-coagulant therapy, or immunosuppressive agent * Major surgical procedure or significant traumatic injury * Patient has other concurrent severe and/or uncontrolled medical conditions. * Concurrent participation in other interventional clinical trial * History of receiving any investigational treatment within 28 days prior to randomization * Pregnant or breast-feeding women or patients not willing to apply highly effective contraception as defined in the protocol * Inability to lie flat or presence of psychiatric disorders such as claustrophobia

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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 official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. 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.

More trials for these conditions

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