TheranosticTrials.org

Clinical Trial · NCT01805908

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)

Overview

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.

Sponsor

Unknown Organization

Phase

Phase 1

Contacts

Raymond Reilly (PRINCIPAL_INVESTIGATOR)

Mark Levine (PRINCIPAL_INVESTIGATOR)

Kathleen Pritchard (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01805908

Drug / Compound

Pertuzumab

Isotope(s):
Target(s):
  • HER2
Ligand Class: Antibodies
Chelator: DTPA

Eligibility

Inclusion

  • Initiating treatment with TmAb
  • 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
  • Clinically measurable disease (by RECIST for patients with metastatic disease).

Exclusion

  • hemoglobin \<9 g/dL,
  • Life expectancy \< 12 weeks.
  • Hypersensitivity to monoclonal antibodies.
  • aspartate aminotransferase (AST) \[serum glutamic oxaloacetic transaminase(SGOT)\] and alanine aminotransferase (ALT) \[serum glutamic pyruvate transaminase(SGPT)\] \>2.5 × ULN,
  • Only site of metastases is liver.
  • Known pregnancy or lactating female (e.g. positive serum beta-human chorionic gonadotropin (B-hCG) pregnancy test).
  • For women of childbearing potential, failure to agree to use a highly effective form of contraception (patient and/or partner, e.g., surgical sterilization) or two effective forms of contraception (a reliable barrier method in conjunction with spermicidal jelly, birth control pills, or contraceptive hormone implants) and to continue its use for the duration of study treatment.
  • absolute neutrophil count \<1,500 cells/mm3,
  • Currently receiving PmAb or lapatinib for treatment of MBC.
  • Left Ventricular Ejection Fraction (LVEF) \< 50% at baseline (within 42 days of study registration) as determined by either echocardiogram (ECHO) or Multi-Gated Acquisition (MUGA) scan.
  • Eastern Cooperative Oncology Group (ECOG) performance status of \> 2.
  • Male gender.
  • Hematology and/or biochemistry parameters outside acceptable ranges:
  • Any condition, which in the investigator's opinion would not make the patient a suitable candidate for inclusion in the trial.
  • Having received TmAb as adjuvant therapy within the previous 6 months.
  • serum creatinine \>2.0 mg/dL or 177 μmol/L,
  • alanine aminotransferase (ALP) \>2.5 x ULN.
  • platelet count \<100,000 cells/mm3,
  • Required to receive another radiopharmaceutical during the first week of the study.
  • Participation in another clinical trial.
  • total bilirubin \> upper limit of normal (ULN) (unless subject has documented Gilbert's Syndrome),