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A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Patients With Advanced Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: July 6, 2009
Last updated: November 1, 2016
Last verified: November 2016
This open-label, multi-center study will assess the safety and tolerability of adding trastuzumab emtansine (T-DM1) to docetaxel in patients with locally advanced or metastatic HER2-positive breast cancer. Patients will receive T-DM1 and docetaxel on Day 1 of each 3-week cycle. For patients with locally advanced breast cancer, pertuzumab may be added to trastuzumab emtansine and docetaxel. Anticipated time on study treatment is up to 6 cycles for patients with locally advanced breast cancer, until disease progression or unacceptable toxicity occurs for patients with metastatic breast cancer.

Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: pertuzumab
Drug: trastuzumab emtansine
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Multi-center Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Dose-limiting toxicities [ Time Frame: approximately 4 years ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS), tumor assessments according to RECIST criteria [ Time Frame: approximately 4 years ]
  • Overall response rate [ Time Frame: approximately 4 years ]
  • Clinical benefit rate (complete response, partial response or stable disease for at least 6 months) [ Time Frame: approximately 4 years ]
  • Duration of response [ Time Frame: approximately 4 years ]
  • Time to treatment failure [ Time Frame: approximately 4 years ]
  • Pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: Pre-dose and 15 min and 4 h post-dose Day 2 Cycle 1 and Day1 Cycles 2-5, end-of-infusion Day 8 Cycles 1-5 ]

Enrollment: 99
Study Start Date: July 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Locally advanced breast cancer Drug: docetaxel
multiple doses
Drug: pertuzumab
multiple doses
Drug: trastuzumab emtansine
multiple doses
Experimental: Metastatic breast cancer Drug: docetaxel
multiple doses
Drug: trastuzumab emtansine
multiple doses


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • ECOG performance status 0-1 (ECOG performance status of 2 will be allowed if only due to debilitating bone disease)
  • HER2-positive metastatic or locally advanced breast cancer
  • For MBC (metastatic breast cancer) patients:
  • documented metastatic or inoperable locally advanced (without meeting LABC criteria) disease, amenable for treatment with docetaxel
  • history of disease progression within 3 months prior to study entry
  • For LABC (locally advanced breast cancer) patients:
  • newly diagnosed locally advanced breast cancer, Stage IIIA-IIIC (AJCC staging system)

Exclusion Criteria:

  • Pregnant or lactating women
  • Significant cardiac disease
  • Inadequate bone marrow, liver or renal function
  • For MBC patients:
  • patients must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases
  • brain metastases that are untreated, symptomatic or require therapy to control symptoms
  • For LABC patients:
  • clinically or radiologically detectable metastasis (M1 disease)
  • patients for whom surgery as primary intent procedure is the best option to treat their disease
  • previous systemic or loco regional anti-cancer therapy for locally advanced disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00934856

United States, North Carolina
Charlotte, North Carolina, United States, 28203
United States, Texas
Houston, Texas, United States, 77005
Dijon, France, 21079
Saint Herblain, France, 44805
Barcelona, Spain, 08003
Madrid, Spain, 28007
Madrid, Spain, 28040
United Kingdom
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00934856     History of Changes
Other Study ID Numbers: BP22572
2009-010000-28 ( EudraCT Number )
Study First Received: July 6, 2009
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Ado-trastuzumab emtansine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic processed this record on March 24, 2017