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

Nantes University Hospital (NUH)

Status and phase

Completed

Phase 2

Phase 1

Conditions

HER2 Negative Breast Carcinoma Expressing CEA

Treatments

Drug: TF2 - 68 Ga-IMP-288:

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01730612

BRD/10/04-O

Details and patient eligibility

About

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;

Full 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 :

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

Enrollment

23 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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