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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) (PETRA)

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ClinicalTrials.gov Identifier: NCT01805908
Recruitment Status : Terminated (Accrual is very poor)
First Posted : March 6, 2013
Last Update Posted : June 6, 2016
Sponsor:
Information provided by (Responsible Party):
Ontario Clinical Oncology Group (OCOG)

Tracking Information
First Submitted Date  ICMJE February 12, 2013
First Posted Date  ICMJE March 6, 2013
Last Update Posted Date June 6, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
  • Change in tumour SUV (Standardized Uptake Value) from baseline to Day 8. [ Time Frame: 8 days ]
    The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 8 (Day 8 SUV - baseline SUV) /baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change.
  • Safety attributable to 111In-Pertuzumab injections [ Time Frame: 3 months ]
    The safety, i.e. toxicities, attributable to 111In-Pertuzumab injections will be evaluated using the National Cancer Institute (NCI) Common Termination for Adverse Events Version 4.
Original Primary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
Change in tumour SUV (Standardized Uptake Value) from baseline to Day 7 and from baseline to Day 28 [ Time Frame: 28 days ]
The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 7 (Day 7 SUV - baseline SUV) /baseline SUV times 100% and the percent changes in tumour SUV from baseline to Day 28/baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change. Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2013)
  • Pharmacokinetics (PK) and tumour and normal tissue localization properties of 111In-PmAb will be measured. [ Time Frame: 3 months ]
    The pharmacokinetics of 111In-PmAb and tumour and normal tissue localization properties of 111In-PmAb will be measured. Standard PK parameters (t1/2 alpha, t1/2β, V1, Vss and CL) will be calculated.
  • Optimal mass dose of 111In-PmAb [ Time Frame: 3 months ]
    The dose of 111In-PmAb that is associated with the optimal SPECT-CT images will be established.
  • Change in tumour SUV from Baseline to Day 36 [ Time Frame: 3 months ]
    The imaging outcome for exploring the association between imaging and clinical outcome is the percent change in tumour SUV from baseline to Day 36 (Day 36 SUV - baseline SUV) /baseline SUV times 100%. The Positron Emission Tomography Evaluation Response Criteria In Solid Tumours (PERCIST) criterion will be used to measure SUV change.
  • Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria. [ Time Frame: 3 months ]
    Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2013)
To determine the feasibility of using labeled pertuzumab to measure trastuzumab binding to breast cancer and to establish the dose of 111In-pertuzumab that is associated with the optimal SPECT-CT images. [ Time Frame: 3 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: March 5, 2013)
  • Safety attributable to 111In-PmAb injections [ Time Frame: 3 months ]
    The safety, i.e. toxicities, attributable to 111In-Pertuzumab injections will be evaluated using the National Cancer Institute (NCI) Common Termination for Adverse Events Version 4.
  • Pharmacokinetics (PK) will be measured [ Time Frame: 3 months ]
    The pharmacokinetics of 111In-PmAb and tumour and normal tissue localization properties of 111In-PmAb will be measured. Standard PK parameters (t1/2 alpha, t1/2β, V1, Vss and CL) will be calculated.
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE Imaging With 111In-Pertuzumab to Predict Response to Trastuzumab in HER2 Positive Metastatic or Locally Advanced Breast Cancer
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE Other: 111In-Pertuzumab + SPECT-CT
111In-PmAb will be provided ready for injection in a vial by Dr. Reilly's laboratory.
Study Arms  ICMJE Experimental: 111In-Pertuzumab + SPECT-CT
Radiopharmaceutical 111In-labeled Pertuzumab given intravenously prior to SPECT-CT imaging.
Intervention: Other: 111In-Pertuzumab + SPECT-CT
Publications * Lam K, Chan C, Done SJ, Levine MN, Reilly RM. Preclinical pharmacokinetics, biodistribution, radiation dosimetry and acute toxicity studies required for regulatory approval of a Clinical Trial Application for a Phase I/II clinical trial of (111)In-BzDTPA-pertuzumab. Nucl Med Biol. 2015 Feb;42(2):78-84. doi: 10.1016/j.nucmedbio.2014.09.011. Epub 2014 Oct 14.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 3, 2016)
3
Original Estimated Enrollment  ICMJE
 (submitted: March 5, 2013)
30
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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.
  2. 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
  3. Initiating treatment with TmAb
  4. Clinically measurable disease (by RECIST for patients with metastatic disease).

Exclusion Criteria:

  1. Male gender.
  2. Less than 18 years of age.
  3. Life expectancy < 12 weeks.
  4. Only site of metastases is liver.
  5. Eastern Cooperative Oncology Group (ECOG) performance status of > 2.
  6. Currently receiving PmAb or lapatinib for treatment of MBC.
  7. Having received TmAb as adjuvant therapy within the previous 6 months.
  8. Required to receive another radiopharmaceutical during the first week of the study.
  9. Hypersensitivity to monoclonal antibodies.
  10. 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.
  11. Hematology and/or biochemistry parameters outside acceptable ranges:

    • absolute neutrophil count <1,500 cells/mm3,
    • platelet count <100,000 cells/mm3,
    • hemoglobin <9 g/dL,
    • total bilirubin > upper limit of normal (ULN) (unless subject has documented Gilbert's Syndrome),
    • aspartate aminotransferase (AST) [serum glutamic oxaloacetic transaminase(SGOT)] and alanine aminotransferase (ALT) [serum glutamic pyruvate transaminase(SGPT)] >2.5 × ULN,
    • serum creatinine >2.0 mg/dL or 177 μmol/L,
    • alanine aminotransferase (ALP) >2.5 x ULN.
  12. Known pregnancy or lactating female (e.g. positive serum beta-human chorionic gonadotropin (B-hCG) pregnancy test).
  13. 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.
  14. Any condition, which in the investigator's opinion would not make the patient a suitable candidate for inclusion in the trial.
  15. Participation in another clinical trial.
  16. Inability to provide informed consent.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01805908
Other Study ID Numbers  ICMJE OCOG-2011-PETRA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ontario Clinical Oncology Group (OCOG)
Study Sponsor  ICMJE Ontario Clinical Oncology Group (OCOG)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Levine Ontario Clinical Oncology Group, McMaster University
Principal Investigator: Raymond Reilly University of Toronto
Principal Investigator: Kathleen Pritchard Ontario Clinical Oncology Group (OCOG)
PRS Account Ontario Clinical Oncology Group (OCOG)
Verification Date June 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP