Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer
The objective of this study is to compare the progression-free survival (PFS) of the drug combination ramucirumab plus docetaxel to placebo plus docetaxel in previously untreated participants with human epidermal growth factor receptor 2 (HER2)-negative, unresectable, locally-recurrent or metastatic breast cancer.
Biological: ramucirumab (IMC-1121B)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official 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|
- Progression-Free Survival (PFS) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]Progression-free survival (PFS) is measured from the date of randomization to the first documented date of disease progression or death from any cause.
- Overall Survival [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]Overall survival is measured as the interval from randomization to the date of death from any cause.
- Time to Progression (TTP) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]Time to progression is the interval from the date of randomization to the first documented date of disease progression.
- Percentage of Participants with Objective Response (Objective Response Rate) [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]The percentage of participants with a confirmed best overall response of complete response (CR) or partial response (PR).
- Duration of Response [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]Duration of response is the interval from date of initial documented response (complete response or partial response) to the first documented date of disease progression or death.
- Total Functional Assessment of Cancer Therapy -Breast (FACT-B): Change From Baseline to End of Therapy [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]FACT-B measures the following domains of health-related quality of life (HR-QL): physical well-being (PWB), social/family well-being (SFWB), emotional well-being (EWB), functional well-being (FWB), & additional concerns of breast cancer (BCS). Total FACT-B scores range from 0-144, with higher scores representing better HR-QOL.
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||August 2015|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
|Experimental: ramucirumab (IMC-1121B) + docetaxel||
Biological: ramucirumab (IMC-1121B)
Ramucirumab (IMC-1121B) is administered at a dose of 10 milligrams per kilogram (mg/kg) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Other Names:Drug: docetaxel
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
|Placebo Comparator: placebo + docetaxel||
Docetaxel is administered at a dose of 75 milligrams per square meter (mg/m²) as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.Other: placebo
Placebo comparator for ramucirumab (IMC-1121B) administered at a dose of 10 mg/kg as a 1-hour intravenous infusion on Day 1 of each 21-day cycle.
Other Name: placebo
Female participants at least 18 years of age with histologically or cytologically confirmed, human epidermal growth factor receptor 2 (HER2) negative breast adenocarcinoma that is metastatic or locally-recurrent and inoperable with curative intent will be randomized. Participants may not have received chemotherapy for metastatic or locally-recurrent, inoperable breast cancer.
It is anticipated that 1113 participants will be randomized with 371 participants in the docetaxel plus placebo arm and 742 participants in the docetaxel plus ramucirumab (IMC-1121B) arm. There will be approximately 250 centers in North and South America, Europe, Asia, Middle East, Africa, Australia, and New Zealand.
On Day 1 of each 21-day cycle, participants will receive docetaxel 75 mg/m² as a one-hour I.V. infusion followed by either ramucirumab (IMC-1121B) 10 mg/kg or placebo 10 mg/kg as a one-hour I.V. infusion. Each cycle is repeated every 21 days.
Treatment will continue until there is evidence of progressive disease, unacceptable toxicity, or other withdrawal criteria are met. Participants who discontinue study treatment with either ramucirumab (IMC-1121B) or placebo may continue to receive docetaxel. Similarly, participants who discontinue docetaxel therapy may continue to receive either ramucirumab (IMC-1121B) or placebo, whichever the participant was randomized to receive. All participants will be followed for survival at regularly scheduled intervals (every 6 weeks until progressive disease and every 6 months thereafter) for at least 36 months after discontinuing study therapy.
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|Study Director:||Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)||Eli Lilly and Company|