A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:3/31/2019
Start Date:October 16, 2008
End Date:September 21, 2022
Contact:Reference Study ID Number: BO25430 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study

This is a global, multicenter, open-label safety extension study. Participants receiving
single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with
other agents in a Genentech/Roche-sponsored parent study who are active and deriving benefit
at the closure of parent study are eligible for continued treatment in this study.


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 dose of study therapy on the extension study or Continue to receive
treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of
the parent study closure if the participant received the last dose of control arm
study drug within the 6 weeks (42 days) prior to the first dose of control arm study
therapy in the extension study

- Participants in the control arm from Study BO21976/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 (NCT00781612)

- Expectation by the investigator that the participant may continue to benefit from
additional single-agent trastuzumab emtansine or combination trastuzumab emtansine
treatment or Expectation of the investigator that the participant may continue to
benefit from control arm treatment as given in study BO21976/TDM4450g and at the time
of disease progression may benefit from single-agent trastuzumab emtansine treatment

- 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 participants and/or partner, and
to continue the use of contraception for the duration of study treatment and for at
least 7 months after the last dose of study treatment

- Male participants whose partners are pregnant should use condoms for the duration of
the pregnancy

Exclusion Criteria:

- AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine
treatment discontinuation in the parent study

- Ongoing SAEs 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 participants from study TDM4688g (NCT00943670) with early
disease progression who went on to receive pertuzumab + trastuzumab emtansine
treatment and have not experienced further disease progression on the combination
regimen

- Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National
Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version
3.0 or 4.0, as utilized in the parent study

- 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 (for example [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 participant'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
We found this trial at
61
sites
4735 Ogletown-Stanton Road
Newark, Delaware 19713
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Minneapolis, Minnesota 55455
(612) 625-5000
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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Aurora, Colorado 80045
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Bedford, Texas 76022
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1351 Kimberly Rd
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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44 Binney Street
Boston, Massachusetts 02115
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701 10th Street Southeast
Cedar Rapids, Iowa 52403
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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3100 Plaza Properties Boulevard
Columbus, Ohio 43219
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4700 East Hale Parkway
Denver, Colorado 80220
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Detroit, Michigan 48201
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1500 East Duarte Road
Duarte, California 91010
626-256-HOPE (4673)
City of Hope National Medical Center City of Hope is dedicated to making a difference...
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4371 Veronica S Shoemaker Boulevard
Fort Myers, Florida 33916
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6409 North Quail Hollow Road
Germantown, Tennessee 38138
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2406 Century Place Southeast
Hickory, North Carolina 28602
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Houston, Texas 77090
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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2021 North MacArthur Boulevard
Irving, Texas 75063
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1501 West Royal Lane
Irving, Texas 75063
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Jacksonville, Florida 32207
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905 Missouri Boulevard
Jefferson City, Missouri 65101
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Lake Success, New York 11042
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161 Fort Washington Avenue
Lake Success, New York 11042
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Livingston, New Jersey 07039
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Los Angeles, California 90095
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340 Kennestone Hospital Boulevard
Marietta, Georgia 30060
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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1400 Northwest 12th Avenue
Miami, Florida 33136
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Minneapolis, Minnesota 55405
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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801 North Flamingo Road
Pembroke Pines, Florida 33028
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Peoria, Illinois 61656
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Philadelphia, Pennsylvania 19111
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USO
Plano, Texas 75075
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5050 Northeast Hoyt Street
Portland, Oregon 97227
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Post Falls, Idaho 83854
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200 First Street SW
Rochester, Minnesota 55905
507-284-2511
Mayo Clinic Rochester Mayo Clinic is a nonprofit worldwide leader in medical care, research and...
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607 S New Ballas Rd
Saint Louis, Missouri 63141
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1201 5th Avenue North
Saint Petersburg, Florida 33705
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San Antonio, Texas 78229
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1600 Divisadero Street
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Santa Maria, California 93454
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2020 Santa Monica Boulevard
Santa Monica, California 90404
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Scarborough, Maine 04074
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501 Eastlake Avenue East
Seattle, Washington 98109
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Springfield, Missouri 65804
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Stanford, California 94305
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Tacoma, Washington 98405
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3402 West Doctor Martin Luther King Junior Boulevard
Tampa, Florida 33607
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The Woodlands, Texas 77380
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910 East Houston Street
Tyler, Texas 75702
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Vallejo, California 94589
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Walnut Creek, California 94596
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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2520 Elisha Avenue
Zion, Illinois 60099
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