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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00934856
First received: July 6, 2009
Last updated: July 7, 2014
Last verified: July 2014
  Purpose

This open-label, multi-center study will assess the safety and tolerability of a dding trastuzumab emtansine (T-DM1) to docetaxel in patients with locally advanc ed or metastatic HER2-positive breast cancer. Patients will receive T-DM1 and do cetaxel on Day 1 of each 3-week cycle. For patients with locally advanced breast cancer, pertuzumab may be added to trastuzumab emtansine and docetaxel. Anticip ated time on study treatment is up to 6 cycles for patients with locally advance d breast cancer, until disease progression or unacceptable toxicity occurs for p atients with metastatic breast cancer.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression Free Survival (PFS), tumor assessments according to RECIST criteria [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Clinical benefit rate (complete response, partial response or stable disease for at least 6 months) [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • Time to treatment failure [ Time Frame: approximately 4 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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: Metastatic breast cancer Drug: trastuzumab emtansine
multiple doses
Drug: docetaxel
multiple doses
Experimental: Locally advanced breast cancer Drug: trastuzumab emtansine
multiple doses
Drug: docetaxel
multiple doses
Drug: pertuzumab
multiple doses

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00934856

Locations
United States, North Carolina
Charlotte, North Carolina, United States, 28203
United States, Texas
Houston, Texas, United States, 77005
France
Dijon, France, 21079
Saint Herblain, France, 44805
Spain
Barcelona, Spain, 08003
Madrid, Spain, 28040
Madrid, Spain, 28041
United Kingdom
Dundee, United Kingdom, DD1 9SY
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00934856     History of Changes
Other Study ID Numbers: BP22572, 2009-010000-28
Study First Received: July 6, 2009
Last Updated: July 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Maytansine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014