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NCT00703326 · ClinicalTrials.gov registry record · Phase 3
Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer
A Phase 3 study, sponsored by Eli Lilly and Company.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,144
- Enrollment target
NCT00703326: Completed Phase 3 study, sponsored by Eli Lilly and Company.
NCT00703326 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 1,144 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00703326, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,144 participants
- Enrollment target
Study Summary
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.
Primary Outcome
PFS was defined as time from randomization until the first evidence of progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause; by Investigator assessment. Progressive disease (PD) was defined as at least a 20% increase in sum of longest diameter of target lesions taking as reference the smallest sum longest diameter since baseline, progression in non-target lesions or the appearance of 1 or more new lesion(s). Participants who neither progres
Interventions
- OTHER Placebo
- DRUG docetaxel
- BIOLOGICAL ramucirumab (IMC-1121B)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,144 participants |
| Start Date | 2008-08-06 |
| Est. Completion | 2020-11-19 |
| Phase | Phase 3 |
What the finished NCT00703326 record still lists
NCT00703326 is an interventional study that assigns participants to a tested intervention. Its 1,144 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (48% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT00703326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00703326 about?
NCT00703326 is a clinical study titled "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...
What is the current status of trial NCT00703326?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,144 participants. The study started on 2008-08-06. Estimated completion is 2020-11-19.
What interventions are being tested in trial NCT00703326?
The interventions under investigation include: Placebo (OTHER), docetaxel (DRUG), ramucirumab (IMC-1121B) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00703326?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00703326's enrollment target sits among peer trials
1,144 243rd of 2000 higher than 1,758 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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