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NCT01234337 · ClinicalTrials.gov registry record · Phase 3
Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
A Phase 3 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 537
- Enrollment target
NCT01234337: Completed Phase 3 study, sponsored by Bayer.
NCT01234337 is a Phase 3 study that has completed, run by Bayer. The registered enrollment target is 537 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01234337, a Phase 3 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 537 participants
- Enrollment target
Study Summary
The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed prior taxane and an anthracycline or for whom further anthracycline therapy is not indicated. After signing consent there can be up to 28 days before starting the treatment during which time a number of tests will be carried out which will include tumor evaluations and medical history. The following tests and evaluations will have to be done within 7 days of the start of treatment,on Day 1 of every cycle and at the end of study: Electrocardiogram, blood tests, patient quality of life questionnaires and a complete physical exam and vital signs. Treatment will be given in 21 day cycles with sorafenib/placebo to be taken every day for 21 days and capecitabine to be taken for the first 14 days. Patients will come in weekly for the first 6 weeks and then on Day1 for every cycle after the first 2 cycles. During the weekly visits the subjects will be check for any side effects and blood draws will happen for the study on Day 1 of each cycle. Subjects will be followed for overall survival.
Primary Outcome
PFS was defined as the time from date of randomization to disease progression, radiological or death due to any cause, whichever occurs first. Per RECIST version 1.1, progressive disease was determined when there was at least 20% increase in the sum of diameters of the target lesions, taking as a reference the smallest sum on study (this included the baseline sum if that was the smallest sum on trial). In addition to a relative increase of 20%, the sum had demonstrated an absolute increase of at
Interventions
- DRUG Placebo
- DRUG Capecitabine
- DRUG Sorafenib (Nexavar, BAY43-9006)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 537 participants |
| Start Date | 2011-02-21 |
| Est. Completion | 2017-10-20 |
| Phase | Phase 3 |
What the finished NCT01234337 record still lists
NCT01234337 is an interventional study that assigns participants to a tested intervention. The registered 537 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01234337 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01234337 about?
NCT01234337 is a clinical study titled "Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer". The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or metastatic HER2-negative breast cancer who are resistant to or have failed p...
What is the current status of trial NCT01234337?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 537 participants. The study started on 2011-02-21. Estimated completion is 2017-10-20.
What interventions are being tested in trial NCT01234337?
The interventions under investigation include: Placebo (DRUG), Capecitabine (DRUG), Sorafenib (Nexavar, BAY43-9006) (DRUG).
Who is sponsoring clinical trial NCT01234337?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01234337's enrollment target sits among peer trials
537 701st of 2000 higher than 1,299 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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