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HER2-PET as a Diagnostic Tool in Breast Cancer Patients With a Clinical Dilemma


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Metastatic Breast Cancer

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Trial Information

HER2-PET as a Diagnostic Tool in Breast Cancer Patients With a Clinical Dilemma


Inclusion Criteria:



1. Patients with a history of histological and/or cytological proven HER2-positive
primary breast cancer. In the Netherlands HER2-positivity is defined as:

- HER2 immunohistochemical score of 3+, or

- HER2 immunohistochemical score of 2+ and positive FISH for HER2/c-erbB2
amplification.

In Belgium HER2-positivity is defined as positive FISH for HER2/c-erbB2
amplification.

2. Patients with suspected metastatic disease or local recurrence of HER2-positive
breast cancer and a clinical dilemma:

- in whom standard work up with imaging has failed to solve the clinical dilemma
(diagnostic/therapeutic), leaving issues with regard to HER2 status of lesions
and

- in whom a biopsy is desirable but cannot (easily) be performed due to technical
or patient factors or otherwise.

3. Standard work-up with imaging is defined as CT chest and abdomen, bone scintigraphy,
as well as FDG-PET.

4. Age >18 years of age.

5. WHO performance status 0-2.

6. Signed written informed consent.

7. Able to comply with the protocol.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Prior allergic reaction to immunoglobulins or immunoglobulin allergy.

3. Inability to comply with study procedures

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Concordance between HER2-PET results and anti-HER2 therapy

Outcome Description:

Concordance between HER2-PET results and anti-HER2 therapy is defined as HER2 positive lesion(s) on HER2-PET and subsequent anti-HER2 therapy; or no HER2 positive lesions on HER2-PET and no subsequent anti-HER2 therapy. It is considered a clinically relevant contribution of HER2-PET to anti-HER2-therapy decisions if there is a concordance in at least 2/3 of included patients.

Outcome Time Frame:

about 2 years (end of study)

Safety Issue:

No

Authority:

Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:

Her2.4

NCT ID:

NCT01832051

Start Date:

March 2013

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • HER2-PET
  • 89Zr-trastuzumab
  • metastatic breast cancer
  • clinical dilemma
  • Breast Neoplasms

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