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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 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.

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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.

Conditions Studied

Breast Cancer

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

FieldValue
Enrollment Target 153 participants
Start Date 2010-10
Est. Completion 2013-06
Phase Phase 2

Sponsor

Hoffmann-La Roche

909 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01196052

The ClinicalTrials.gov registry entry for NCT01196052 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (95% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.