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)

NCT01805908 | Terminated Phase 1 DMC

• 1 other identifier: OCOG-2011-PETRA
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

metastatic; breast cancer; herceptin; imaging; tumour response; adenocarcinoma; SPECT-CT; pertuzumab; trastuzumab; locally advanced

Outcome Measures

Primary Outcomes (2)

• Change in tumour SUV (Standardized Uptake Value) from baseline to Day 8.

  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.

  8 days

• Safety attributable to 111In-Pertuzumab injections

  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.

  3 months

Secondary Outcomes (4)

• Pharmacokinetics (PK) and tumour and normal tissue localization properties of 111In-PmAb will be measured.

  3 months

• Optimal mass dose of 111In-PmAb

  3 months

• Change in tumour SUV from Baseline to Day 36

  3 months

• Clinical response (complete or partial) to treatment will be measured using Response Evaluation Criteria In Solid Tumours (RECIST) criteria.

  3 months

Study Arms (1)

111In-Pertuzumab + SPECT-CT

EXPERIMENTAL

Radiopharmaceutical 111In-labeled Pertuzumab given intravenously prior to SPECT-CT imaging.

Other: 111In-Pertuzumab + SPECT-CT

Interventions

111In-Pertuzumab + SPECT-CT OTHER

111In-PmAb will be provided ready for injection in a vial by Dr. Reilly's laboratory.

111In-Pertuzumab + SPECT-CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Currently receiving PmAb or lapatinib for treatment of MBC.
• Having received TmAb as adjuvant therapy within the previous 6 months.
• Required to receive another radiopharmaceutical during the first week of the study.
• Hypersensitivity to monoclonal antibodies.
• 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.
• 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),

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead

Study Sites (2)

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Location

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Location

Related Publications (1)

• 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.

  PMID: 25459109 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Adenocarcinoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Mark Levine

  Ontario Clinical Oncology Group, McMaster University

  PRINCIPAL INVESTIGATOR

• Raymond Reilly

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Kathleen Pritchard

  Ontario Clinical Oncology Group (OCOG)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2013
• First Posted: March 6, 2013
• Study Start: November 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 6, 2016

Record last verified: 2016-06

Locations

CA (2)