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ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA (iTEPsein)

This study is ongoing, but not recruiting participants.
Institut National de la Santé Et de la Recherche Médicale, France
Immunomedics, Inc.
Information provided by (Responsible Party):
Nantes University Hospital Identifier:
First received: November 12, 2012
Last updated: January 17, 2017
Last verified: January 2017

Main objective: To determine the optimal molar doses of the biospecific antibody TF2 and 68 Ga-IMP-288 and the optimal time for pretargeting for immuno-PET in patients with breast carcinoma.

Secondary objectives: To study the sensitivity of the immuno-PET, compare its performance to standard imaging methods, evaluate the safety of 150 MBq of 68 Ga-IMP-288; study the development of immunization against TF2 or complex TF2-IMP-288;

Condition Intervention Phase
HER2 Negative Breast Carcinoma Expressing CEA
Drug: TF2 - 68 Ga-IMP-288:
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pilot Study for Optimization of Immuno-PET Pretargeted With Anti-CEA Bispecific Antibody X Anti-HSG TF2 and the Peptide IMP-288 Radiolabeled With Gallium-68 -Pharmacokinetic and Imaging for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA

Resource links provided by NLM:

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • evaluation of the tumor targeting (no Unit) and signal / noise ratio (no unit) by the immunoTEP with TF2 and 68-Ga-IMP-288 [ Time Frame: One week ]
    Pk blood after injections of TF2 and 68 Ga-IMP-288 and PET imaging semi-quantification with 60 to 120 minutes after injection of 68 Ga-IMP-288

Secondary Outcome Measures:
  • Sensibility, tolerance [ Time Frame: 6 months after immunoTEP ]
    sensitivity of the immuno-PET and compare its performance to standard imaging methods, pathological data if available data or imaging follow-up of at least 6 months by RECIST and EORTC

  • To study the contribution of immnoTEP to assess early response to treatment, compare its performance to standard imaging methods [ Time Frame: month 6 ]

    6 weeks after initiation of treatment of metastases (after the first iTEP), a second _iTEP with a therapeutic evaluation will be carried out. The examination requirements are identical to those of the first immunoTEP.

    this second iITEP will be evaluated in regard of imaging assessment performed routinely (TAP scanner, FDG-PET, CA15-3 and CEA)

Other Outcome Measures:
  • • To assess the tolerance of 150 MBq of 68 Ga-IMP-288 [ Time Frame: 6 months ]
  • To search for the development of immunization with TF2 and the complex TF2-IMP-288: ELISA [ Time Frame: 6 months ]

Enrollment: 23
Study Start Date: December 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: TF2 - 68 Ga-IMP-288:
    Other Names:
    • TF2: trivalent recombinant humanized antibody recognizing the ACE and the peptide histamine-succinyl-glycine IMP-288 (HSG)
    • 68 Ga-IMP-288: di-HSG peptide-DOTA-labeled with Gallium 68
  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Breast carcinoma, HER2 + (Dako) and HER2 + (fish) metastatic at least after treatment with current consensus
  • ≥ 18 years
  • Negative pregnancy test for women of childbearing age. Women of childbearing age should take effective contraception continuously for 3 months.
  • Karnofsky ≥ 70 or ECOG 0-1

    •• ACE of the tumor by immunohistochemistry or positive plasma CEA ≥ 10 ng / mL

  • At least one measurable lesion on CT
  • creatinine < 2.5
  • Informed consent signed
  • Social insurance

Exclusion Criteria:

  • Pregnancy or breastfeeding

    • Serious illness or co-morbidity risk assessed
    • History of cancer within 5 years except skin cancer other than melanoma or carcinoma in situ of the cervix
    • Presence of anti-antibodies in patients who have previously received antibodies
    • Known hypersensitivity to antibodies or proteins
    • intellectual disability to sign the informed consent
    • Not controlled diabetes
    • Persons protected by law
  Contacts and Locations
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Please refer to this study by its identifier: NCT01730612

Nantes, France, 44093
Institut de Cancérologie de l'Ouest
Saint Herblain, France, 44805
Sponsors and Collaborators
Nantes University Hospital
Institut National de la Santé Et de la Recherche Médicale, France
Immunomedics, Inc.
Principal Investigator: francoise Bodere, PhD, MD Nantes Hospital
  More Information

Responsible Party: Nantes University Hospital Identifier: NCT01730612     History of Changes
Other Study ID Numbers: BRD/10/04-O
Study First Received: November 12, 2012
Last Updated: January 17, 2017

Keywords provided by Nantes University Hospital:
HER2 negative
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Disease Attributes
Pathologic Processes
Neoplasms by Site
Breast Diseases
Skin Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on May 22, 2017