A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Patients With HER2-Positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-Directed Therapy (TH3RESA) - Full Text View

Purpose

This randomized, multicenter, two-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in patients with metastatic or unresectable locally advanced/recurrent HER2-positive breast cancer. Eligible patients will be randomized to receive either T-DM1 3.6 mg/kg intravenously every 21 days or treatment of the physician's choice. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs. This study is also known under Roche study protocol number BO25734.

Condition	Intervention	Phase
Breast Cancer	Drug: trastuzumab emtansine [Kadcyla] Drug: anti-cancer therapy	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase III Randomized, Multicenter, Two-Arm, Open-Label Trial to Evaluate the Efficacy of Trastuzumab Emtansine Compared With Treatment of Physician's Choice in Patients With HER2 Positive Metastatic Breast Cancer Who Have Received at Least Two Prior Regimens of HER2 Directed Therapy

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab Trastuzumab emtansine

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Progression-free survival by investigator assessment according to RECIST [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective response rate [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Duration of objective response (DOR) [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Land mark survival rate (6 months/1 year) [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Time to pain symptom progression as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire BM22 [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Global Health Status/Quality of Life as measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Global Health Status as measured by Euro-Qol 5D [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Pharmacokinetics: serum concentration of trastuzumab emtansine [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Pharmacokinetics: plasma concentration of DM1 [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	600
Study Start Date:	September 2011
Estimated Study Completion Date:	October 2015
Estimated Primary Completion Date:	October 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	Drug: trastuzumab emtansine [Kadcyla] 3.6 mg/ kg intravenously every 21 days
Active Comparator: B Drug: anti-cancer therapy	Drug: anti-cancer therapy Treatment of physician's choice (chemotherapy, hormonal therapy, biologic drug and/or HER2-directed therapy)

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
Histologically or cytologically documented breast cancer
Metastatic or unresectable locally advanced/recurrent breast cancer
HER2-positive disease by prospective laboratory confirmation
Disease progression on the last regimen received as defined by the investigator
Prior treatment with an trastuzumab, a taxane, and lapatinib
Disease progression after at least two regimens of HER2-directed therapy in the metastatic or unresectable locally advanced/recurrent setting
Adequate organ function, as evidenced by laboratory results
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
LVEF >/= 50% by ECHO or MUGA

Exclusion Criteria:

Chemotherapy </= 21 days before first study treatment
Trastuzumab </= 21 days before first study treatment
Lapatinib </= 14 days before first study treatment
Prior enrolment in a T-DM1 containing study, regardless whether the patient received prior T-DM1
Brain metastases that are untreated or symptomatic, or require any radiation, surgery or corticosteroid therapy to control symptoms within 1 month of randomization

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419197

Contacts

Contact: Please reference Study ID Number: TDM4997g www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Show 182 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Melanie Smitt, M.D.

Genentech

More Information

No publications provided

Responsible Party:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT01419197 History of Changes
Other Study ID Numbers:	TDM4997g, BO25734, 2011-000509-29
Study First Received:	August 16, 2011
Last Updated:	May 13, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
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 May 22, 2013