PET scans could guide smarter breast cancer therapy
NCT ID NCT07527806
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 156 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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