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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 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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


The study treatment will be administered until disease progression, unacceptable toxicity or
patient willingness to discontinue.


Inclusion Criteria:



- Post-menopausal women

- Aromatase inhibitor as the last hormonal treatment

- Breast adenocarcinoma with positive hormone receptor

- Measurable disease as per RECIST definition

Exclusion Criteria:

- ECOG performance status (PS) > 2

- Prior exposure to fulvestrant or to an anti IGF-1R compound

- No evidence of hormonosensitivity

- HER 2-neu positive tumor

- More than one prior regimen of chemotherapy for metastatic disease

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical benefit defined as a confirmed complete response (CR) or a confirmed partial response (PR) or a stable disease (SD)lasting at least 24 weeks (6 cycles)

Outcome Time Frame:

6 cycles

Safety Issue:

No

Principal Investigator

Henri ROCHE, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut Claudius Regaud (TOULOUSE - FRANCE)

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

TCD10631

NCT ID:

NCT00774878

Start Date:

October 2008

Completion Date:

November 2010

Related Keywords:

  • Breast Neoplasms
  • Breast cancer
  • Breast Tumors
  • Anti IGF-1R
  • Hormonosensitivity
  • Breast Neoplasms
  • Neoplasms

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