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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00796107
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : July 28, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will determine the safety and efficacy of R1507 in combination with letrozole 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 po daily in combination with R1507 16mg/kg every 3 weeks. A second cohort of patients who have either progressed or plateaued on letrozole treatment will receive 3-weekly cycles of combination treatment with letrozole and R1507. The anticipated time on study treatment is until disease progression or unacceptable toxicity, and the target sample size is <100 individuals.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: RG1507 Drug: letrozole Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : January 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole

Arm Intervention/treatment
Experimental: R1507 in Combination With Letrozole Drug: RG1507
16mg/kg iv every 3 weeks

Drug: letrozole
2.5mg po daily

Primary Outcome Measures :
  1. Adverse events (Part 1) [ Time Frame: Throughout study ]
  2. Objective tumor response (Part 2) [ Time Frame: Weeks 6, 12, 18, 24 and then every 12 weeks ]

Secondary Outcome Measures :
  1. Adverse events and laboratory parameters, pharmacokinetics (PK) profile (Part 2) [ Time Frame: Throughout study ]
  2. Progression-free survival, time to progression, time to response (Part 2) [ Time Frame: Event driven ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • postmenopausal female patients;
  • stage IV or locally advanced breast cancer;
  • measurable disease;
  • letrozole failure (Part 2);
  • Eastern Cooperative Oncology Group (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00796107

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
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00796107     History of Changes
Other Study ID Numbers: NO21161
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: July 28, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs