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

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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;

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborators: Gilead Sciences; Immunomedics, Inc.; Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Antibodies; Glycine; Histamine

Criteria

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