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

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ClinicalTrials.gov Identifier: NCT00796107
Recruitment Status : Terminated (Due to the discontinuation of compound development, this study has been terminated.)
First Posted : November 24, 2008
Results First Posted : November 13, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study aim was to 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 received letrozole 2.5mg po daily in combination with R1507 16mg/kg every 3 weeks.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
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.
Actual Study Start Date : January 28, 2009
Actual Primary Completion Date : March 3, 2010
Actual Study Completion Date : March 3, 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
Participants received a full daily dose of 2.5 mg of orally administered Letrozole along with 16 mg/kg of intravenous R1507 administered q3w, and observed for dose limiting toxicity for the first 2 cycles of treatment.
Drug: RG1507
R1507 was administered at a dose 16 mg/kg every 3 weeks.

Drug: Letrozole
Letrozole was administered orally at a dose 2.5 mg daily.




Primary Outcome Measures :
  1. Objective Tumor Response (Part 2) [ Time Frame: Up to 14 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) Profile (Part 2) [ Time Frame: Up to 14 months ]
  2. Progression-free Survival (Part 2) [ Time Frame: Up to 14 months ]
  3. Number of Participants With Adverse Events (Part 2) [ Time Frame: Up to 14 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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);
  • 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 ClinicalTrials.gov identifier (NCT number): NCT00796107


Locations
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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
Saint Louis, Missouri, United States, 63110
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00796107    
Other Study ID Numbers: NO21161
First Posted: November 24, 2008    Key Record Dates
Results First Posted: November 13, 2020
Last Update Posted: November 13, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
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