Alert icon

To align with industry best practices for security and data integrity, Project Data Sphere is requiring users to upgrade their browsers to one that supports encryption protocol TLS 1.2 by December 15, 2017. On that date, Project Data Sphere will disable support of browsers that permit SSL 3.0/TLS 1.0. To prevent any disruption to your access to Project Data Sphere, you must take action.
This browser was not recognized and may not be compatible with TLS 1.2 or higher. Please check with the browser's developer to confirm.
To view information about this, please visit the FAQ. If you have any further questions, please contact us.

The Project Data Sphere Cancer Research Platform will be unavailable from 5 PM Eastern Time on Friday, 10/20 until 1 AM on Monday, 10/23 for necessary maintenance.

Breast

A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients with HER2 Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer

Unique Data Set IDBreast_EliLill_2008_168
DownloadableYes
SponsorEli Lilly & CompanyData ProviderEli LillyTotal Study Enrolled Patients1144Comparator (Control) Arm Enrolled Patients385RandomizationYesClinicalTrial.gov IDNCT00703326ClinicalTrial.gov URLhttps://clinicaltrials.gov/ct2/show/NCT00703326?term=NCT00703326&rank=1
Study PhaseClinical Study Phase III, Clinical Study Phase IIBBlinding MethodDouble-BlindedType(s) of dataOnly comparator arm dataIntervention TypeChemotherapyData Set TypeOther

Clinical Trial Title

A Multicenter, Multinational, Randomized, Double-Blind, Phase III Study of IMC-1121B Plus Docetaxel Versus Placebo Plus Docetaxel in Previously Untreated Patients with HER2 Negative, Unresectable, Locally-Recurrent or Metastatic Breast Cancer

Trial Summary and Conditions

Study Design: ROSE was a global, Phase 3, multicenter, randomized, double-blind, placebo-controlled study that compared ramucirumab in combination with docetaxel to placebo in combination with docetaxel in previously untreated patients with HER2-negative, unresectable, locally-recurrent or mBC. Randomization was stratified by prior taxane therapy (yes/no), visceral metastasis (yes/no), hormone receptor status (positive vs. negative/unknown), and geographical region (the Americas vs. Europe/Australia/New Zealand vs. Asia/Middle East/Africa). Patients were randomized on a 2:1 basis to receive on Day 1 (? 3 days) of each 21-day cycle, either: ? Docetaxel (75 mg/m2) as an approximately 1-hour intravenous (IV) infusion followed by ramucirumab (10 mg/kg) as an approximately 1-hour IV infusion; or ? Docetaxel (75 mg/m2) as an approximately 1-hour IV infusion followed by placebo (10 mg/kg) as an approximately 1-hour IV infusion.

Data Summary

Control arm data on patient characteristics, efficacy (PFS, OS, ORR), safety, etc.

Study Objectives

The primary objective of this study was to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated patients with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer (mBC). The secondary objectives of this study were to compare the overall survival (OS), time to progression (TTP), objective response rate (ORR), duration of response (DR), quality of life (QoL), and safety between the 2 treatment arms; and to assess the immunogenicity of ramucirumab.

Outcome Measures

The primary objective of this study was to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated patients with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer (mBC). The secondary objectives of this study were to compare the overall survival (OS), time to progression (TTP), objective response rate (ORR), duration of response (DR), quality of life (QoL), and safety between the 2 treatment arms; and to assess the immunogenicity of ramucirumab.

Available Downloads:

To gain access to the data and analytic tools click here.

PROTOCOL: V8.0 Protocol CP12-0606_Redacted.pdf

CRF: JVBC_SDTM_aCRF_redacted.pdf

DATA DICTIONARY: JVBC_ADaM_dataset_specifications_redacted.pdf

DATA (COMPARATOR ARM): adam20161103.zip