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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: Completed Phase 1 study, sponsored by Hoffmann-La Roche.
NCT00875979 is a Phase 1 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 67 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A patient had an objective response if they had a complete response or a partial response on 2 consecutive occasions ≥ 4 weeks apart. For target lesions, a complete response was defined as the disappearance of all target lesions; a partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. For non-target lesions, a complete response was defined as the disappearance of all non-target lesions;
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 |
What the finished NCT00875979 record still lists
NCT00875979 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab emtansine [Kadcyla] 3.0 mg/kg is the first listed.
NCT00875979 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00875979's enrollment target sits among peer trials
67 782nd of 2000 higher than 1,215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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