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NCT01196052 · ClinicalTrials.gov registry record · Phase 2
A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
- 20
- Study locations
NCT01196052: Completed Phase 2 study of Breast Cancer, sponsored by Hoffmann-La Roche.
NCT01196052 is a Phase 2 study of Breast Cancer that has completed, run by Hoffmann-La Roche. The registered enrollment target is 153 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01196052, a Phase 2 study of Breast Cancer, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
- 20
- Study locations
Study Summary
This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 of each 3-week cycle, for up to 17 cycles.
Primary Outcome
A cardiac event was defined as death from a cardiac cause or severe congestive failure (New York Heart Association \[NYHA\] Class III or IV) with a decrease in left ventricular ejection fraction (LVEF) of ≥ 10% from Baseline to an LVEF of \< 50%.
Conditions Studied
Interventions
- DRUG Trastuzumab emtansine
Study Locations (20)
Other
- - Brussels
- - Wilrijk
- - Besançon
- - Montpellier
- - Saint-Herblain
Massachusetts
- - Boston
- - Boston
North Carolina
- - Durham
- - Winston-Salem
Florida
- - Fort Myers
Indiana
- - Lafayette
Maine
- - Scarborough
Maryland
- - Kensignton
Missouri
- - Springfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2010-10 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01196052 record still lists
NCT01196052 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Trastuzumab emtansine is the first listed.
NCT01196052 names 20 study sites across 14 states, led by Other, Massachusetts, North Carolina.
Frequently Asked Questions
What is clinical trial NCT01196052 about?
NCT01196052 is a clinical study titled "A Study of Trastuzumab Emtansine (T-DM1) Sequentially With Anthracycline-based Chemotherapy, as Adjuvant or Neoadjuvant Therapy for Patients With Early Stage Herceptin (HER)2-positive Breast Cancer". This single-arm open-label study assessed the safety, feasibility, and efficacy of trastuzumab emtansine (T-DM1) after the completion of anthracycline-based adjuvant/neoadjuvant chemotherapy in patients with early HER2-positive breast cancer. Patients received T-DM1 3.6 mg/kg intravenously on Day 1 ...
What is the current status of trial NCT01196052?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2010-10. Estimated completion is 2013-06.
What conditions does trial NCT01196052 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT01196052?
The interventions under investigation include: Trastuzumab emtansine (DRUG).
Who is sponsoring clinical trial NCT01196052?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01196052 being conducted?
This trial has 20 study locations across Florida, Indiana, Maine, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01196052's enrollment target sits among peer trials
153 441st of 1224 higher than 783 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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