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An Exploratory Study to Evaluate the Biological Activity of R1507, a Human Monoclonal Antibody Antagonist of the Insulin-like Growth Factor Receptor (IGF-1R) in Women With Operable Breast Cancer


Phase 1
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

An Exploratory Study to Evaluate the Biological Activity of R1507, a Human Monoclonal Antibody Antagonist of the Insulin-like Growth Factor Receptor (IGF-1R) in Women With Operable Breast Cancer


Inclusion Criteria:



- female patients, >=18 years of age;

- invasive, and operable, breast cancer;

- ECOG Performance Status of 0 or 1.

Exclusion Criteria:

- evidence of metastatic disease;

- inflammatory breast cancer;

- prior hormonal or systemic therapy for breast cancer;

- prior treatment with an agent targetting the IGF-1R pathway;

- patients receiving concurrent radiotherapy, or who have received radiotherapy within
28 days prior to receipt of study drug.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Outcome Measure:

Percent reduction in IGF-1R expression

Outcome Time Frame:

From initial diagnosis to tumor excision

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Scotland: Scottish Executive Health Department

Study ID:

NP22002

NCT ID:

NCT00882674

Start Date:

July 2009

Completion Date:

December 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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