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NCT00875979 · ClinicalTrials.gov registry record · Phase 1
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
A Phase 1 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 1
- Development phase
- 67
- Enrollment target
NCT00875979 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 67 participants.
The verdict
NCT00875979, a Phase 1 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 67 participants
- Enrollment target
Study Summary
This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally advanced or metastatic breast cancer who had previously received trastuzumab.
Interventions
- DRUG Trastuzumab emtansine [Kadcyla] 3.0 mg/kg
- DRUG Trastuzumab emtansine [Kadcyla] 3.6 mg/kg
- DRUG Pertuzumab 420 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2009-05 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00875979
The ClinicalTrials.gov registry entry for NCT00875979 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab emtansine [Kadcyla] 3.0 mg/kg is the first listed.
NCT00875979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00875979 about?
NCT00875979 is a clinical study titled "A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab". This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients wi...
What is the current status of trial NCT00875979?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2009-05. Estimated completion is 2011-08.
What interventions are being tested in trial NCT00875979?
The interventions under investigation include: Trastuzumab emtansine [Kadcyla] 3.0 mg/kg (DRUG), Trastuzumab emtansine [Kadcyla] 3.6 mg/kg (DRUG), Pertuzumab 420 mg (DRUG).
Who is sponsoring clinical trial NCT00875979?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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