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

• 4 or 5 cohorts of 3 patients receiving different doses of TF2 IMP-288 with different interval time. A last cohort (4 or 5 ): maximum of 21 additional patients with the optimal schedule.

Cohort I: TF2 120 nmol / 6 nmol IMP-288 / 24 hours

Cohort II: based on the results of the cohort I :

• Good signal of the tumor but high background: increased interval time, 120 nmol TF2 / 6 nmol of IMP-288 / 30 hours
• Low signal of the tumor: reduction of the interval time, 120 nmol TF2 / 6 nmol IMP-288 / 18 hours
• Good signal of the tumor and good background signal : dose reduction, 60 nmol TF2 / 3nmol IMP- 288 / 24 hours

Cohort III: based on results of cohort II:

• Good signal of the tumor : dose reduction, 120 nmol TF2 / 3 nmol IMP-288 / 30 h

Cohort IV : based on results of cohort III Cohort V : Based on results of cohort IV

• A last Cohort (VI) : 19 patients with the optimal schedule of injection : 120 nmol TF2 / 3 nmol IMP-288 / 30 h or 120 nmol TF2 / 6 nmol IMP-288 / 30 h

• In the four weeks prior to the immuno-PET:

• Clinical examination,

• CEA and CA15-3,

• thoraco abdominal pelvic scan, bone scan, FDG-PET,

• immunohistochemistry ACE on the tumor if possible,

• Anti-Antibodies if the patient has already received MAb,

• pregnancy test within 2 days prior to immuno-PET,

• (creatinine > 2.5 normal) D0: Injection of TF2 D1 to D4: injection of 68 Ga-IMP-288 (depending of the cohort) D0 to D4 : pharmacokinetics, imaging

Evaluation at 1 month of Immuno-PET:

• Assessment of the clinical oncologist and

• histological biopsy and / or surgery performed according to the results of imaging and assessment of the potential clinical impact

Evaluation at 3 and 6 months of immuno-PET:

based on the results of immuno-PET, evaluation and therapeutic decision of the oncologist,

• Imaging (ultrasound, bone scintigraphy, CT or PET FDG),

• markers
• Anti-Antibody Search
• For patient with a cancer treatment a new immuno-PET can be proposed

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