Trial record 1 of 1 for:    TH3RESA
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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)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01419197
First received: August 16, 2011
Last updated: January 6, 2014
Last verified: January 2014

August 16, 2011
January 6, 2014
September 2011
June 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Objective response rate by independent review, tumor assessments according to RECIST criteria [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01419197 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Progression-free survival (PFS) [ 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 ]
  • Clinical benefit rate, defined as proportion of patients achieving an objective response or stable disease for at least 6 months from randomization [ 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 ]
Not Provided
Not Provided
 
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)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: trastuzumab emtansine [Kadcyla]
    3.6 mg/ kg intravenously every 21 days
  • Drug: anti-cancer therapy
    Treatment of physician's choice (chemotherapy, hormonal therapy, biologic drug and/or HER2-directed therapy)
  • Experimental: A
    Intervention: Drug: trastuzumab emtansine [Kadcyla]
  • Active Comparator: B
    Drug: anti-cancer therapy
    Intervention: Drug: anti-cancer therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
604
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Brazil,   Canada,   Czech Republic,   France,   Germany,   Hungary,   India,   Israel,   Italy,   Korea, Republic of,   Norway,   Poland,   Russian Federation,   Slovakia,   Spain,   Sweden,   Switzerland,   Thailand,   United Kingdom
 
NCT01419197
TDM4997g, BO25734, 2011-000509-29
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Melanie Smitt, M.D. Genentech
Hoffmann-La Roche
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP