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:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01419197
First received: August 16, 2011
Last updated: May 23, 2013
Last verified: May 2013
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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:
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 ]
| Enrollment: | 606 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 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
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| United States, Arizona | |
| Tucson, Arizona, United States, 85704 | |
| United States, Arkansas | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, California | |
| Hayward, California, United States, 94545 | |
| Highland, California, United States, 92346 | |
| Oakland, California, United States, 94611 | |
| Roseville, California, United States, 95661 | |
| Sacramento, California, United States, 95825 | |
| San Diego, California, United States, 92108 | |
| San Francisco, California, United States, 94115 | |
| San Jose, California, United States, 95119 | |
| Santa Clara, California, United States, 95051 | |
| South San Francisco, California, United States, 94080 | |
| Stockton, California, United States, 95204 | |
| Vallejo, California, United States, 94589 | |
| Walnut Creek, California, United States, 94596 | |
| West Hollywood, California, United States, 90048 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80220 | |
| United States, Connecticut | |
| Trumbull, Connecticut, United States, 06611 | |
| United States, Delaware | |
| Newark, Delaware, United States, 19713 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Coral Springs, Florida, United States, 33065 | |
| Deerfield Beach, Florida, United States, 33442 | |
| Fort Myers, Florida, United States, 33905 | |
| Jacksonville, Florida, United States, 32256 | |
| Plantation, Florida, United States, 33324 | |
| United States, Georgia | |
| Marietta, Georgia, United States, 30060 | |
| United States, Idaho | |
| Post Falls, Idaho, United States, 83854 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60612 | |
| Chicago, Illinois, United States, 60637 | |
| Maywood, Illinois, United States, 60153 | |
| United States, Indiana | |
| Fort Wayne, Indiana, United States, 46815 | |
| United States, Iowa | |
| Sioux City, Iowa, United States, 51108 | |
| United States, Kansas | |
| Wichita, Kansas, United States, 67214-3728 | |
| United States, Maine | |
| Scarborough, Maine, United States, 04074 | |
| United States, Maryland | |
| Bethesda, Maryland, United States, 20817 | |
| Columbia, Maryland, United States, 21044 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02115 | |
| Boston, Massachusetts, United States, 02215 | |
| Boston, Massachusetts, United States, 02130 | |
| United States, Michigan | |
| Detroit, Michigan, United States, 48201 | |
| United States, Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68114 | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States, 08901 | |
| United States, New York | |
| Bronx, New York, United States, 10467 | |
| Lake Success, New York, United States, 11042 | |
| United States, North Carolina | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, Ohio | |
| Columbus, Ohio, United States, 43219 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97210 | |
| United States, Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Charleston, South Carolina, United States, 29414 | |
| United States, Tennessee | |
| Chattanooga, Tennessee, United States, 37404 | |
| Nashville, Tennessee, United States, 37232 | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Dallas, Texas, United States, 75246 | |
| Fort Worth, Texas, United States, 76104 | |
| San Antonio, Texas, United States, 78229 | |
| United States, Virginia | |
| Richmond, Virginia, United States, 23230 | |
| United States, Washington | |
| Seattle, Washington, United States, 98109 | |
| Australia, New South Wales | |
| Kogarah, New South Wales, Australia, 2217 | |
| Australia, Queensland | |
| South Brisbane, Queensland, Australia, 4101 | |
| Australia, Victoria | |
| Frankston, Victoria, Australia, 3199 | |
| Australia, Western Australia | |
| Perth, Western Australia, Australia, 6000 | |
| Belgium | |
| Leuven, Belgium, 3000 | |
| Wilrijk, Belgium, 2610 | |
| Brazil | |
| Salvador, BA, Brazil, 41950-610 | |
| Goiania, GO, Brazil, 74140-050 | |
| Rio de Janeiro, RJ, Brazil, 22260-020 | |
| Porto Alegre, RS, Brazil, 90430090 | |
| Itajai, SC, Brazil, 88301-220 | |
| Sao Paulo, SP, Brazil, 01509-900 | |
| Canada, New Brunswick | |
| Moncton, New Brunswick, Canada, E1C 6Z8 | |
| Canada, Ontario | |
| Toronto, Ontario, Canada, M4N 3M5 | |
| Canada, Saskatchewan | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Saskatoon, Saskatchewan, Canada, S7N 4H4 | |
| Canada | |
| Quebec, Canada, G1S 4L8 | |
| Czech Republic | |
| Brno, Czech Republic, 656 53 | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Olomouc, Czech Republic, 775 20 | |
| Praha 2, Czech Republic, 128 08 | |
| Praha 5, Czech Republic, 150 06 | |
| France | |
| Angers, France, 49933 | |
| Bordeaux, France, 33300 | |
| Caen, France, 14076 | |
| Lyon, France, 69373 | |
| Montpellier cedex 5, France, 34298 | |
| Nantes, France, 44202 | |
| Nice, France, 06189 | |
| Nimes, France, 30900 | |
| Paris, France, 75231 | |
| Reims CEDEX, France, 51056 | |
| Rouen, France, 76038 | |
| St-Priest-En-Jarez, France, 42271 | |
| Strasbourg, France, 67065 | |
| Toulouse, France, 31059 | |
| Toulouse, France, 31300 | |
| Tours, France, 37044 | |
| Villejuif, France, 94800 | |
| Germany | |
| Bielefeld, Germany, 33604 | |
| Hamburg, Germany, 20251 | |
| Hamburg, Germany, 22081 | |
| Hannover, Germany, 30559 | |
| Kiel, Germany, 24105 | |
| Mainz, Germany, 55131 | |
| München, Germany, 80638 | |
| Ravensburg, Germany, 88212 | |
| Recklinghausen, Germany, 45657 | |
| Stuttgart, Germany, 70190 | |
| Trier, Germany, 54290 | |
| Troisdorf, Germany, 53840 | |
| Hungary | |
| Budapest, Hungary, 1122 | |
| Budapest, Hungary, 1145 | |
| Gyula, Hungary, 5700 | |
| Kecskemet, Hungary, 6000 | |
| Miskolc, Hungary, 3526 | |
| Szeged, Hungary, 6701 | |
| Szolnok, Hungary, 5004 | |
| India | |
| Bangalore, India, 560027 | |
| Chennai, India, 600035 | |
| Kolkata, India, 700053 | |
| New Delhi, India, 110085 | |
| Pune, India, 411001 | |
| Pune, India, 411004 | |
| Israel | |
| Beer Sheva, Israel, 8410101 | |
| Hafia, Israel, 3109601 | |
| Jerusalem, Israel, 91120 | |
| Petach Tikva, Israel, 49100 | |
| Ramat-Gan, Israel, 52621 | |
| Rehovot, Israel, 76100 | |
| Tel Aviv, Israel, 64239 | |
| Italy | |
| Bergamo, Italy, 24127 | |
| Biella, Italy, 13900 | |
| Brescia, Italy, 25123 | |
| Cona (Ferrara), Italy, 44124 | |
| Genova, Italy, 16132 | |
| Milano, Italy, 20132 | |
| Milano, Italy, 20121 | |
| Napoli, Italy, 80131 | |
| Potenza, Italy, 85100 | |
| Korea, Republic of | |
| Kyunggi-do, Korea, Republic of, 410-769 | |
| Seoul, Korea, Republic of, 135-170 | |
| Seoul, Korea, Republic of, 120-752 | |
| Seoul, Korea, Republic of, 110-744 | |
| Seoul, Korea, Republic of, 138-736 | |
| Norway | |
| Oslo, Norway, 0310 | |
| Poland | |
| Bialystok, Poland, 15-027 | |
| Bydgoszcz, Poland, 85-796 | |
| Gdansk, Poland, 80-952 | |
| Lublin, Poland, 20-090 | |
| Poznan, Poland, 61-866 | |
| Warszawa, Poland, 02-781 | |
| Russian Federation | |
| Moscow, Russian Federation, 115478 | |
| Samara, Russian Federation, 443031 | |
| Stavropol, Russian Federation, 355045 | |
| Slovakia | |
| Kosice, Slovakia, 04001 | |
| Poprad, Slovakia, 058 01 | |
| Spain | |
| La Coruna, La Coruña, Spain, 15009 | |
| Bilbao, Vizcaya, Spain, 48013 | |
| Barcelona, Spain, 08907 | |
| Barcelona, Spain, 08036 | |
| Madrid, Spain, 28034 | |
| Madrid, Spain, 28040 | |
| Madrid, Spain, 28033 | |
| Malaga, Spain, 29010 | |
| Murcia, Spain, 30008 | |
| Sevilla, Spain, 41014 | |
| Valencia, Spain, 46026 | |
| Sweden | |
| Umea, Sweden, 90185 | |
| Uppsala, Sweden, 75185 | |
| Örebro, Sweden, 701 85 | |
| Switzerland | |
| Bern, Switzerland, 3010 | |
| Zürich, Switzerland, 8091 | |
| Thailand | |
| Bangkok, Thailand, 10400 | |
| Bangkok, Thailand, 10110 | |
| Bangkok, Thailand, 10700 | |
| United Kingdom | |
| Brighton, United Kingdom, BN2 5BE | |
| Guildford, United Kingdom, GU2 7XX | |
| London, United Kingdom, W1G 6AD | |
| Maidstone, United Kingdom, ME16 9QQ | |
| Nottingham, United Kingdom, NG5 1PB | |
| Sheffield, United Kingdom, S10 2SJ | |
| Stoke-on-Trent, United Kingdom, ST4 6QG | |
| Westcliffe-on-sea, United Kingdom, SS0 0RY | |
| Wirral, United Kingdom, L63 4JY | |
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 23, 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 23, 2013