immunotep au 68-ga- imp-288 for patients with a recurrence of her2 negative breast carcinoma expressing cea

Conditions: HER2 Negative Breast Carcinoma Expressing CEA

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;

* 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 : 1. good signal of the tumor but high background: increased interval time, 120 nmol tf2 / 6 nmol of imp-288 / 30 hours 2. low signal of the tumor: reduction of the interval time, 120 nmol tf2 / 6 nmol imp-288 / 18 hours 3. 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

Eligibility 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

Keywords: immunotep her2 negative breast cancer