Multicenter, randomized, open label study evaluating an anti Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) monoclonal antibody, AVE1642, administered every 4 weeks in combination with fulvestrant (Faslodex®) in postmenopausal patients with advanced hormono-dependent breast cancer

Phase 1

• Conditions: Advanced hormono-dependent breast cancer; MedDRA version: 10.1Level: LLTClassification code 10006204Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2008-000810-54-FR
• Lead Sponsor: sanofi-aventis recherche et développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-05-22
• Study Completion: 2010-11-10
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

•Post-menopausal women (age = 60 years or history of bilateral oophorectomy or prior castration or age = 50 years amenorrheic with FSH > 50 IU/L ) who failed to no more than 2 prior anti-hormonotherapy
•Histologically proven invasive breast adenocarcinoma with positive hormone receptor (ER+ and/or Pg+) (defined as = 10% tumor staining by IHC method)
•Aromatase inhibitor as the last hormonal treatment
•Histologically proven metastasis in case of a unique site
•Measurable disease as per RECIST definition (longest diameter = 20mm using conventional technique or = 10 mm with spiral CT scan)
•Written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Methodology related:
? < 18 years old
? ECOG performance status (PS) > 2
? Inadequate organ function:
1.Neutrophils (ANC) < 1,500/mm3
2.Hemoglobin < 10g/dl
3.Platelets < 100,000/mm3
4.Total bilirubin > 1.5 ULN
5.ASAT ALAT > 2.5 ULN
6.Creatininemia > 1.5 ULN (or = 2.0 mg/dl)
7.INR > 1.6
? HbA1c > 8%
? No measurable disease as defined by RECIST criteria
? Previous radiotherapy on the only measurable metastatic site
? History of cerebral metastasis symptomatic or not, leptomeningeal disease
? Patients with only bone metastasis, pleural effusion, ascitis or lung lymphangitis carcinomatosis
? No evidence of hormonosensitivity defined in the case of an early relapse (within the first 12 months during adjuvant therapy and in case of advanced disease setting as tumor response or stabilization for less than 12 weeks before progression).
? HER 2-neu positive tumor
? More than one prior regimen of chemotherapy for metastatic disease
? Prior exposure to fulvestrant or to anti IGF1-R compound
? Biphosphonate treatment initiated less than 1 week before study entry
? Any of the following within 6 months prior to enrollment: myocardial infarction, severe/ unstable angina, or coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhytmias (grade 3-4)
? Other severe underlying medical conditions, which could impair the ability to participate in the study
? Patient unwilling and /or unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

•Related to the active comparator (fulvestrant):
? Known contraindication to fulvestrant: hypersensitivity to the active substance or to any of the excipients
? Anti-coagulant continuous treatment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified