Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

An Extension Study of Trastuzuma Emtansine in Patients Previously Treated With Trastuzuma Emtansine

This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
Genentech, Inc. Identifier:
First received: October 27, 2008
Last updated: February 26, 2015
Last verified: February 2015

This is a global, multicenter, open-label extension study. Patients receiving single-agent T-DM1 or combination T-DM1 administered in combination with paclitaxel or with pertuzumab ± paclitaxel in a Genentech/Roche-sponsored study who completed the parent study or who continue to receive study drug(s) at the time of the parent study closure are eligible for continued treatment on this protocol.

Condition Intervention Phase
Breast Cancer
Drug: docetaxel
Drug: paclitaxel
Drug: pertuzumab [Perjeta]
Drug: trastuzumab [Herceptin]
Drug: trastuzumab emtansine [Kadcyla]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Multicenter Extension Study of Trastuzumab-MCC-DM1 (T-DM1) Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Treated With the Equivalent T-DM1 Regimen in a Genentech and/or F. Hoffmann-La Roche Ltd.-Sponsored T-DM1 Study

Resource links provided by NLM:

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Incidence of adverse events leading to T-DM1 or combination treatment discontinuation or dose reduction [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Incidence of all adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
  • Incidence of all serious adverse events [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 720
Study Start Date: October 2008
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: docetaxel
Intravenous repeating dose
Drug: paclitaxel
Intravenous repeating dose
Drug: pertuzumab [Perjeta]
Intravenous repeating dose
Drug: trastuzumab [Herceptin]
Intravenous repeating dose
Drug: trastuzumab emtansine [Kadcyla]
Intravenous repeating dose


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

Inclusion Criteria:

  • Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks (42 days) prior to the first scheduled dose of study therapy on the extension study or Continue to receive treatment in the control arm of Study TDM4450g at the time of the parent study closure if the patient received the last dose of control arm study drug within the 6 weeks (42 days) prior to the first scheduled dose of control arm study therapy in the extension study
  • Patients in the control arm from Study TDM4450g whose disease progression has occurred during the transition interval between the parent study and this extension study may initiate trastuzumab emtansine treatment at the time of enrollment into Study TDM4529g
  • Expectation by the investigator that the patient may continue to benefit from additional single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment or Expectation of the investigator that the patient may continue to benefit from control arm treatment as given in Study TDM4450g and at the time of disease progression may benefit from single-agent trastuzumab emtansine treatment
  • Patients from parent study BO25499 must be on a stable dose of trastuzumab emtansine for at least two cycles
  • Women of childbearing potential and men with partners of childbearing potential, must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 6 months after the last dose of study treatment
  • Male patients whose partners are pregnant should use condoms for the duration of the pregnancy

Exclusion Criteria:

  • Adverse event(s)leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study
  • Ongoing serious adverse event(s) from the parent study
  • Progressive disease on single-agent trastuzumab emtansine or a trastuzumab emtansine-containing regimen during the parent study or before starting the extension study, with the exception of patients from Study TDM4688g with early PD who went on to receive pertuzumab + trastuzumab emtansine treatment and have not experienced further disease progression on the combination regimen
  • Peripheral neuropathy of Grade >/= 3 per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 3.0
  • History of symptomatic congestive heart failure ([CHF]; New York Heart Association [NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable angina, or history of myocardial infarction within 6 months prior to study entry
  • Severe dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
  • Current severe, uncontrolled systemic disease (e.g. clinically significant cardiovascular, pulmonary, or metabolic disease)
  • Major surgical procedure or significant traumatic injury within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment Current pregnancy or lactation
  • History of receiving any investigational treatment or other systemic therapy directed at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the patient?s last study drug dose in the parent study
  • History of hypersensitivity with previous trastuzumab emtansine or any agent used with trastuzumab emtansine in the parent study, precluding further dosing
  • Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
  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: NCT00781612

  Hide Study Locations
United States, California
Los Angeles, California, United States, 90095-1772
San Francisco, California, United States, 94115
San Luis Obispo, California, United States, 93454
Santa Monica, California, United States, 90404
Stanford, California, United States, 94305-5456
Vallejo, California, United States, 94589
Walnut Creek, California, United States, 94596
United States, Colorado
Aurora, Colorado, United States, 80045
Denver, Colorado, United States, 80220
United States, Delaware
Newark, Delaware, United States, 19713
United States, Florida
Fort Myers, Florida, United States, 33916
Hollywood, Florida, United States, 33021
Saint Petersburg, Florida, United States, 33705
Tampa, Florida, United States, 33607
United States, Georgia
Marietta, Georgia, United States, 30060
United States, Idaho
Post Falls, Idaho, United States, 83854
United States, Illinois
Maywood, Illinois, United States, 60153
Peoria, Illinois, United States, 61615
Zion, Illinois, United States, 60099
United States, Indiana
Indianapolis, Indiana, United States, 46202
United States, Iowa
Bettendorf, Iowa, United States, 52722
Cedar Rapids, Iowa, United States, 52403
United States, Kansas
Wichita, Kansas, United States, 67214-3728
United States, Massachusetts
Boston, Massachusetts, United States, 02114
Boston, Massachusetts, United States, 02115
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Minnesota
Minneapolis, Minnesota, United States, 55407
Minneapolis, Minnesota, United States, 55454
United States, Missouri
Saint Louis, Missouri, United States, 63141
United States, New Jersey
Livingston, New Jersey, United States, 07039
United States, New York
Lake Success, New York, United States, 11042
New York, New York, United States, 10065
United States, North Carolina
Hickory, North Carolina, United States, 28602
United States, Ohio
Cleveland, Ohio, United States, 44195
Columbus, Ohio, United States, 43219
United States, Oregon
Portland, Oregon, United States, 97227
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19111
United States, Tennessee
Nashville, Tennessee, United States, 37203
United States, Texas
Bedford, Texas, United States, 76022
Dallas, Texas, United States, 75231
Fort Worth, Texas, United States, 76177
Houston, Texas, United States, 77030
Plano, Texas, United States, 75075-7787
The Woodlands, Texas, United States, 77380
Tyler, Texas, United States, 75702
United States, Washington
Seattle, Washington, United States, 98109
Tacoma, Washington, United States, 98405
Wilrijk, Belgium, 2610
Salvador, BA, Brazil, 41950-610
Rio de Janeiro, RJ, Brazil, 20230-130
Porto Alegre, RS, Brazil, 90430-090
Porto Alegre, RS, Brazil, 90020-090
Porto Alegre, RS, Brazil, 91350-200
Itajai, SC, Brazil, 88301-220
Santo Andre, SP, Brazil, 09060-650
Sao Paulo, SP, Brazil, 01317-000
Plovdiv, Bulgaria, 4004
Sofia, Bulgaria, 1756
Canada, British Columbia
Kelowna, British Columbia, Canada, V1Y 5L3
Canada, Ontario
Ottawa, Ontario, Canada, K1Y 4K7
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Montreal, Quebec, Canada, H2W 1T8
Santiago, Chile, Providencia
Caen, France, 14076
Dijon, France, 21079
Marseille, France, 13273
Paris, France, 75231
Saint Herblain, France, 44805
Aschaffenburg, Germany, 63739
Berlin, Germany, 14169
Berlin, Germany, 13125
Köln, Germany, 50931
Stralsund, Germany, 18435
Hong Kong
Hong Kong, Hong Kong
Szombathely, Hungary, 9700
Jerusalem, Israel, 91031
Tel Aviv, Israel, 6423906
Catanzaro, Calabria, Italy, 88100
Meldola, Emilia-Romagna, Italy, 47014
Parma, Emilia-Romagna, Italy, 43100
Aviano (PN), Friuli-Venezia Giulia, Italy, 33081
Udine, Friuli-Venezia Giulia, Italy, 33100
Milano, Lombardia, Italy, 20141
Milano, Lombardia, Italy, 20133
Sassari, Sardegna, Italy, 07100
Pisa, Toscana, Italy, 56100
Korea, Republic of
Gyeonggi-do, Korea, Republic of, 410-769
Seoul, Korea, Republic of, 110-774
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 120-749
Acapulco, Mexico, 39670
D.f., Mexico, 14080
Lima, Peru, 18
Quezon City, Luzon, Philippines, 1101
Gdansk, Poland, 80-214
Poznan, Poland, 61-866
Warszawa, Poland, 02-781
Porto, Portugal, 4200-072
Russian Federation
Saint-Petersburg, Russian Federation, 197758
Singapore, Singapore, 119228
Barcelona, Spain, 08035
Barcelona, Spain, 08003
Lerida, Spain, 25198
Madrid, Spain, 28007
Madrid, Spain, 28046
Sevilla, Spain, 41013
Zaragoza, Spain, 50009
Eskilstuna, Sweden, 63188
Taoyuan, Taiwan, 333
United Kingdom
Dundee, United Kingdom, DD12 9SY
Manchester, United Kingdom, M20 4BX
Poole, United Kingdom, BH15 2JB
Sponsors and Collaborators
Genentech, Inc.
Study Director: Clinical Trials Genentech, Inc.
  More Information

No publications provided

Responsible Party: Genentech, Inc. Identifier: NCT00781612     History of Changes
Other Study ID Numbers: TDM4529g, BO25430
Study First Received: October 27, 2008
Last Updated: February 26, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on March 03, 2015