A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00796107
First received: November 21, 2008
Last updated: August 4, 2014
Last verified: August 2014

November 21, 2008
August 4, 2014
January 2009
June 2010   (final data collection date for primary outcome measure)
  • Adverse events (Part 1) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Objective tumor response (Part 2) [ Time Frame: Weeks 6, 12, 18, 24 and then every 12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00796107 on ClinicalTrials.gov Archive Site
  • Adverse events and laboratory parameters, PK profile (Part 2) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Progression-free survival, time to progression, time to response (Part 2) [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer
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.

This study will determine the safety and efficacy of R1507 in combination with l etrozole in patients with advanced breast cancer. In the first part of the study a cohort of patients with advanced breast cancer will receive letrozole 2.5mg p

o daily in combination with R1507 16mg/kg every 3 weeks. A second cohort of pati ents who have either progressed or plateaued on letrozole treatment will receive 3-weekly cycles of combination treatment with letrozole and R1507. The anticipa ted time on study treatment is until disease progression or unacceptable toxicit y, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: RG1507
    16mg/kg iv every 3 weeks
  • Drug: letrozole
    2.5mg po daily
Experimental: 1
Interventions:
  • Drug: RG1507
  • Drug: letrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00796107
NO21161
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP