Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Hu… (NCT01805908) | Clinical Trial Compass
TerminatedPhase 1
Imaging With 111 Indium (111In)-Pertuzumab (PmAb) to Predict Response to Trastuzumab (TmAb) in Human Epidermal Growth Factor-2 (HER2) Positive Metastatic Breast Cancer (MBC) or Locally Advanced Breast Cancer (LABC)
Stopped: Accrual is very poor
Canada3 participantsStarted 2013-11
Plain-language summary
The general objective of the study is to improve the care of women with Human Epidermal Growth Factor Receptor-2 (HER2) positive metastatic or locally advanced breast cancer by using a radio-labelled biomarker with whole body Single Photon Emission Computed Tomography (SPECT) imaging to predict who will respond to treatment with Trastuzumab.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Metastatic, locally recurrent (local recurrence not amenable to surgical resection of curative intent), or locally advanced (T3 or T4, any N, M0) adenocarcinoma of the breast.
✓. Tumour HER2 positive by immunohistochemistry for HER2 protein over-expression or by Fluorescence in situ Hybridization (FISH) for HER2 gene amplification, as defined by American Society of Clinical Oncology/College of American Pathologists guidelines
✓. Initiating treatment with TmAb
✓. Clinically measurable disease (by RECIST for patients with metastatic disease).
Exclusion criteria
✕. Male gender.
✕. Less than 18 years of age.
✕. Life expectancy \< 12 weeks.
✕. Only site of metastases is liver.
✕. Eastern Cooperative Oncology Group (ECOG) performance status of \> 2.
✕
What they're measuring
1
Change in tumour SUV (Standardized Uptake Value) from baseline to Day 8.
Timeframe: 8 days
2
Safety attributable to 111In-Pertuzumab injections