Imaging patients for cancer drug selection - metastatic breast cancer

• Conditions: Metastatic Breast Cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000551-41-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-12
• Last Update Posted: 24 March 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

1. Patient with first presentation of MBC, regardless of ER and HER2 status of the primary tumor, who is eligible for first-line systemic therapy.
2. Patient with non-rapidly progressive MBC, not requiring urgent initiation of chemotherapy, based on clinician's evaluation which may include:
•no recent (< 2 weeks prior to screening visit) significant worsening of MBC related signs and symptoms according to patient history.
•in case of liver metastases: no significant (>50%) increase in liver function tests ASAT and ALAT in 2 weeks prior to screening visit.
3. Patients in whom standard imaging work-up of MBC was recently (= 28 days) performed. Standard imaging must include: CT chest/abdomen, 18F-FDG-PET and bone scintigraphy.
4. Patient with measurable or clinically evaluable (bone only) disease on recent standard work up of MBC are eligible.
5. Metastatic lesion(s) of which a histological biopsy can safely be obtained according to standard clinical care procedures.
6. Primary tumor blocks available for confirmatory central laboratory ER/HER2 testing in the UMCG. If available a snap frozen sample of the primary tumor will also be centralized in the UMCG.
7. WHO performance status 0-2.
8. Patient is able to undergo PET imaging procedures.
9. Age >18 years of age, willing and able to comply with the protocol as judged by the investigator.
10. Signed written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Contraindications for systemic treatment (as will be assigned based on biopsy and experimental scan results), either chemotherapy, hormonal therapy or anti-HER2 therapy, based on clinical judgment of treating medical oncologist and patient history.
2. Pregnant or lactating women.
3. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.
4. Inability to comply with study procedures.
5. Rapidly progressive (visceral) disease requiring rapid initiation of chemotherapy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified