EUCTR2011-005437-39-NL
Active, not recruiting
Phase 1
A phase II prospective imaging study evaluating the utility of pre-treatment zirconium-89 labelled trastuzumab PET/CT and an early FDG-PET/CT response to identify patients with advanced HER-2 positive breast cancer unlikely to benefit from a novel anti-HER2 therapy: T-DM1 - ZEPHIR
Conditionsocally recurrent (not amenable to resection with curative intent) or metastatic disease scheduled for a first or any subsequent metastatic treatment lineMedDRA version: 19.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 19.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- ocally recurrent (not amenable to resection with curative intent) or metastatic disease scheduled for a first or any subsequent metastatic treatment line
- Sponsor
- Jules Bordet Institute
- Enrollment
- 105
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.The patient must have histologically confirmed HER2 positive invasive carcinoma of the breast in the reference laboratory of the participating center. HER2 positive criteria to be applied are those used in the participating countries:
- •Belgium: FISH amplification ratio ? 2 in the reference laboratory of the participating center
- •The Netherlands: IHC 3\+ or FISH ratio ?2 in the reference laboratory of the participating center
- •2\.The patient must have documented progressive disease and present with at least 2 non\-bone target” metastatic lesions, unequivocally of neoplastic origin with
- •a transaxial diameter greater than 2 cm on the screening diagnostic CT/MRI for all non\-bone lesions except lymphnodes
- •a short axis greater than 1,5 cm for lymphnodes on the screening diagnostic CT/MRI
- •These two lesions should not be confluent with adjacent lesions and not have been irradiated previously.
- •3\.A concurrent biopsy of a metastatic site is mandatory (with two formalin fixed paraffin embedded (FFPE) core sample and two snap frozen tumor sample) after progression has been documented and before inclusion and the patient agrees with the procedure.
- •4\.Primary tumor blocks (or 11 unstained slides) available for confirmatory central laboratory HER2 testing in Institut Jules Bordet. If available, a snap frozen sample of the primary tumor will also be centralized in Institut Jules Bordet.
- •5\.Age \= 18 years
Exclusion Criteria
- •1\.Patients with bone only metastases are not eligible.
- •2\.Diffuse liver (\=50%) involvement on imaging.
- •3\.Patients with brain metastasis as the sole site of metastatic disease and/or are symptomatic or require therapy to control symptoms
- •NB: Brain metastasis are allowed provided they are asymptomatic and/or controlled by previous radiotherapy. In case of recent prior brain radiotherapy, there must be evidence on MRI imaging of brain metastatic control for at least 6 weeks since the end of radiotherapy. Moreover, the patient should be at the end of corticosteroid therapy and be clinically asymptomatic.
- •4\.Current uncontrolled hypertension despite medication intake (systolic ? 150 mmHg and/or diastolic ? 100 mmHg)
- •5\.Current unstable angina
- •6\.History of symptomatic CHF of any New York Heart Association (NYHA) criteria or ventricular arrhythmia that requires treatment
- •7\.History of myocardial infarction within the last 6 months
- •8\.History of a decrease in LVEF to \< 40% or symptomatic CHF with previous trastuzumab treatment
- •9\.Current dyspnea at rest due to complications of advanced malignancy, or other diseases that require continuous oxygen therapy
Outcomes
Primary Outcomes
Not specified
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