[89Zr]trastuzumab PET/CT imaging of HER2 positive breast cancer for predicting pathologic complete response after neoadjuvant chemotherapy; a multicentre study

Phase 2

Completed

Conditions: 10006232
Breast cancer

Registration Number: NL-OMON50044

Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 7

Inclusion Criteria

• Female patients aged 18 years or older.
• Confirmed diagnosis of HER2 positive primary breast cancer (confirmed by
immunohistochemical staining of preoperative core-needle biopsy of tumor
tissue; IHC with strong intensity 3+ or fluorescence in situ hybridization
(FISH)) and eligible for breast cancer surgery.
• Tumor size >= 5 mm (0.5 cm) diameter according to anatomical imaging data.
• WHO performance score 0-2.
• Patients planned for neoadjuvant therapy.
• Female patients need to be either surgically sterile, post-menopausal or
pre-menopausal and not pregnant. Pre-menopausal female patients who are not
surgically sterile should also employ an effective method of birth control for
at least one month post-dosing when it consists of a hormonal contraceptive
method or IUD. For other contraceptive methods, premenopausal females who are
not surgically sterile have to agree to use an effective method of
contraception.
• Absence of any psychological, familial, sociological or geographical
condition potentially hampering compliance with the study protocol and
follow-up schedule; those conditions should be discussed with the patient
before registration in the trial.
• Before patient registration, written informed consent must be given according
to ICH/GCP, and national/local regulations.

Exclusion Criteria

• Any condition that in the opinion of the investigator could potentially
jeopardize the health status of the patient.
• Medical or psychiatric conditions that compromise the patient*s ability to
give informed consent. Presence of any psychological, familial, sociological or
geographical condition potentially hampering compliance with the study protocol
and follow-up schedule.
• Prior radiotherapy to the targeted breast.
• Breast prosthesis in the target breast.
• Unacceptable known (clinical significant) cardiovascular or pulmonary
disease, renal or liver dysfunction.
• Known hypersensitivity to drugs comparative to trastuzumab or drugs in the
same class (immunoglobulins), or any of their excipients or to any component of
[89Zr]trastuzumab.
• Concomitant medication known to interact with trastuzumab.
• Inability to undergo PET/CT scanning (e.g. claustrophobia, weight limits or
inability to tolerate lying for the duration of an PET/CT scan (~30 min)).

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine if HER2 positive primary breast cancer can be detected by<br /><br>[89Zr]trastuzumab PET/CT imaging, using histopathological examination as the<br /><br>gold standard, after neoadjuvant treatment.<br /><br>- Assess the negative predictive value and sensitivity of [89Zr]trastuzumab<br /><br>PET/CT imaging to detect HER2 positive primary breast cancer.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Assess agreement between [89Zr]trastuzumab PET/CT-imaging signal in the tumor<br /><br>and axilla, histopathologic evidence of tumor and HER2 expression.<br /><br>- Assess the agreement between different imaging modalities ([89Zr]trastuzumab<br /><br>PET/CT-scan, [18F]FDG-PET/CT and MRI).</p><br>