A Study to Evaluate the Biological Activity of R1507 in Women With Operable Breast Cancer

Hoffmann-La Roche8 enrolled

Overview

This 2 part study will explore the pharmacodynamic effects of R1507 in breast cancer tumor cells in female patients with operable breast cancer. In the first part of the study, patients will receive a single dose of R1507, 16mg/kg iv, on day 1; pre-and post-treatment (at breast surgery on day 8) breast tissue samples will be obtained for measurement of IGF-1R expression. If sufficient biological activity is demonstrated, 3 additional cohorts of patients will be entered into Part 2 of the study, to receive a single dose of 9mg, 3mg/kg or 1mg/kg iv R1507, respectively. The anticipated time on study treatment is \< 3 months, and the target sample size is \<100 individuals.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Percent reduction in IGF-1R expression

Time frame: From initial diagnosis to tumor excision

Secondary Outcomes

Correlation of R1507 pharmacokinetic parameters with biological changes in tumor tissue

Time frame: Days 1, 8 and 31

Adverse events, laboratory parameters

Time frame: Throughout study