Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Letrozole

Aromatase Inhibitors

Enzyme Inhibitors

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

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.

R1507 was administered at a dose 16 mg/kg every 3 weeks.

RG1507

Letrozole was administered orally at a dose 2.5 mg daily.

Clinical Trials

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.

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.

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).

Hoffmann-La Roche

R1507 in Combination With Letrozole

Age, Categorical

Sex: Female, Male

White

Race/Ethnicity, Customized

Study Director

Objective Tumor Response (Part 2)

Pharmacokinetics (PK) Profile (Part 2)

Progression-free Survival (Part 2)

Since Phase 2 of this study was not conducted, this outcome measure was not collected.

Number of Participants With Adverse Events (Part 2)

Overall Study

Spots Global Cancer Trial Database for A Study of R1507 in Combination With Letrozole in Postmenopausal Women With Advanced Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial