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An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

An Open Label Study to Evaluate the Safety, Tolerability and Effect on Tumor Response of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer.


Inclusion Criteria:



- postmenopausal female patients;

- stage IV or locally advanced breast cancer;

- measurable disease;

- letrozole failure (Part 2);

- ECOG performance status <=2.

Exclusion Criteria:

- previous chemotherapy for metastatic breast cancer;

- concurrent antibody or immunotherapy for advanced disease, within 4 weeks prior to
receipt of study drug;

- history of primary malignancy in 5 years prior to study, excluding adequately treated
basal or squamous cell cancer of skin, or cancer in situ of cervix;

- concurrent radiotherapy, or radiotherapy within 28 days prior to receipt of study
drug.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse events (Part 1)

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO21161

NCT ID:

NCT00796107

Start Date:

January 2009

Completion Date:

June 2010

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Albany, Georgia  31701
Birmingham, Alabama  35294
Miami, Florida  33176
Columbia, Missouri  65203
Austin, Texas  78705
Washington, District of Columbia