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NCT00567190 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
A Phase 3 study, sponsored by Genentech.
- Completed
- Registry status
- Phase 3
- Development phase
- 808
- Enrollment target
NCT00567190 is a Phase 3 study that has completed, run by Genentech. The registered enrollment target is 808 participants.
The verdict
NCT00567190, a Phase 3 study, has completed, sponsored by Genentech.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 808 participants
- Enrollment target
Study Summary
This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment. Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.
Interventions
- DRUG Trastuzumab
- DRUG Placebo
- DRUG Docetaxel
- DRUG Pertuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 808 participants |
| Start Date | 2008-02-12 |
| Est. Completion | 2018-11-23 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00567190
The ClinicalTrials.gov registry entry for NCT00567190 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 808 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Genentech, which has 332 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.
NCT00567190 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00567190 about?
NCT00567190 is a clinical study titled "A Study to Evaluate Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer". This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2...
What is the current status of trial NCT00567190?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 808 participants. The study started on 2008-02-12. Estimated completion is 2018-11-23.
What interventions are being tested in trial NCT00567190?
The interventions under investigation include: Trastuzumab (DRUG), Placebo (DRUG), Docetaxel (DRUG), Pertuzumab (DRUG).
Who is sponsoring clinical trial NCT00567190?
This trial is sponsored by Genentech, which has 332 total clinical trials registered on ClinicalTrials.gov.
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