Spots Global Cancer Trial Database for ImmunoTEP au 68-Ga- IMP-288 for Patients With a Recurrence of HER2 Negative Breast Carcinoma Expressing CEA

Study Description

Brief 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;

Detailed Description: * 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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Contact Details

Useful links and downloads for this trial