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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: November 24, 2014
Last verified: November 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: RG1507
Drug: letrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 6
Study Start Date: January 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RG1507
16mg/kg iv every 3 weeks
Drug: letrozole
2.5mg po daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796107

Locations
United States, Alabama
Birmingham, Alabama, United States, 35294-3300
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, Florida
Miami, Florida, United States, 33136
United States, Georgia
Atlanta, Georgia, United States, 30322
United States, Missouri
St. Louis, Missouri, United States, 63110
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00796107     History of Changes
Other Study ID Numbers: NO21161
Study First Received: November 21, 2008
Last Updated: November 24, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014