T-DM1 vs Paclitaxel/Trastuzumab for Breast (ATEMPT Trial)



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:8/23/2018
Start Date:May 2013
End Date:December 2021

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A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)

This research study is a Phase II clinical trial. Phase II clinical trials test the
effectiveness of an investigational drug to learn whether the drug works in treating a
specific cancer. "Investigational" means that the drug is still being studied and that
research doctors are trying to find out more about it-such as the safest dose to use, the
side effects it may cause, and if the drug is effective for treating different types of
cancer. It also means that the FDA has not approved this drug for use patients undergoing
adjuvant treatment for HER2+ breast cancer. Trastuzumab emtansine (T-DM1) is a drug that may
stop cancer cells from growing. This drug has been used in other research studies and
information from those other research studies suggests that this drug may help to prevent the
recurrence of breast cancer in this research study.

The use of T-DM1 in this research study is experimental, which means it is not approved by
any regulatory authority for the adjuvant treatment of HER2-positive breast cancer. However,
it FDA-approved for metastatic HER2-positive breast cancer. T-DM1 has caused cancer cells to
die in laboratory studies. In preclinical studies, this drug has prevented or slowed the
growth of breast cancer. The breast cancer treatments (paclitaxel and Trastuzumab) used in
this study are considered part of standard-of-care regimens in early breast cancer. A
standard treatment means that this is a treatment that would be accepted by the majority of
the medical community as a suitable treatment for your type of breast cancer.

In this research study, the investigators are looking to see if the study drug T-DM1 will
have less side effects than traditional HER2-positive breast cancer treatment of trastuzumab
and paclitaxel. The investigators are also hoping to learn about the long term benefits and
disease-free survival of participants who take the study drug T-DM1 in comparison to those
participants to take the combination of trastuzumab and paclitaxel.

If a participant agrees to participate in this study she will be asked to undergo some
screening tests or procedures to confirm that she is eligible. Many of these tests and
procedures are likely to be part of regular cancer care and may be done even if turns out
that she does not take part in this research study. If she has had some of these tests or
procedures recently, they may or may not have to be repeated. These tests and procedures will
include: a medical history, performance status, assessment of your tumor, blood tests,
cardiac tests, pregnancy test and a collection of tumor tissue. If these tests show that she
is eligible to participate in the research study, she will begin the study treatment. If she
does not meet the eligibility criteria, she will not be able to participate in this research
study.

Because no one knows which of the study options is best, the participant will be "randomized"
into one of the study groups after she has had her breast surgery: Group 1 or Group 2.
Randomization means that she is put into a group by chance. Neither the participant nor the
research doctor will choose what group she will be in. The participant will have a one in
three chance of being placed in any group. Approximately 375 study participants will receive
the study drug, while 125 study participants will receive the standard therapy of trastuzumab
and paclitaxel.

Group 1 participants will receive the study drug T-DM1 every three weeks by IV (intravenous
injection) for 17 treatments (total of 51 weeks).

Group 2 participants will receive the FDA-approved drugs Paclitaxel and Trastuzumab once per
week by IV for 12 weeks. Then beginning week 13, participants will receive Trastuzumab only
by IV injection every three weeks for the next 13 treatments.

During all cycles the participant will have a physical exam and tumor assessment.

The investigators would like to keep track of the participant's medical condition for the
next five years after the final dose of study drug. The investigators would like to do this
by regular visits every 6 months for 3 years after completion of study treatment, and then
once a year for the next two years. The investigators may ask for additional follow-up by
phone after completion of these visits.

Participants who undergo lumpectomy (breast conserving surgery) need to receive breast
radiation therapy to participate in this study. Participants who have undergone a mastectomy
may receive chest wall and lymph node radiation (as determined by discussion with their
physician). Radiation Therapy will begin after the conclusion of all study paclitaxel doses,
and after 12 weeks fo the study drug T-DM1.

Inclusion Criteria:

- HER2-positive Stage I histologically confirmed invasive carcinoma of the breast

- ER/PR determination is required

- HER2 positive, confirmed by central testing: IHC 3+, FISH HER2/CEP17 <2.0 with an
average HER2 copy number >/=6.0, or FISH HER2/CEP17 >/= 2.0

- Bilateral breast cancers that individually meet eligibility criteria are allowed

- Subjects with multifocal or multicentric disease are eligible as long as each tumor
individually meets eligibility criteria

- Subjects with a history of ipsilateral DCIS are eligible if they were treated with
wide-excision alone, without radiation therapy; Patients with a history of
contralateral DCIS are not eligible.

- Should have tumor tissue available and a tissue block of sufficient size to make 15
slides, which must be sent to a DFCI site for testing

- Less than or equal to 90 days since most recent breast surgery for this breast cancer

- All tumor should be removed by either a modified radical mastectomy or a segmental
mastectomy (lumpectomy) with either a sentinel node biopsy or axillary dissection

- All margins should be clear of invasive cancer or DCIS

- May have received up to 4 weeks of tamoxifen therapy or other hormonal therapy, for
adjuvant therapy for this cancer

- Prior oophorectomy for cancer prevention is allowed

- Subjects who have undergone partial breast radiation (duration registration are eligible. Partial breast radiation must be completed prior to 2 weeks
before starting protocol therapy.

- Must have discontinued any investigational drug at least 2 weeks prior to
participation

- Willing to use one highly effective from of nonhormonal contraception or two effective
forms of nonhormonal contraception while on study and for 7 months after end of study
treatment

- Subjects undergoing lumpectomy must have no contraindications to radiation therapy

Exclusion Criteria:

- Pregnant or breastfeeding

- Use of potent CYP3A4 inhibitors during the study treatment period

- Excessive alcohol intake (more than 3 alcoholic beverages per day)

- Locally advanced tumors at diagnosis

- History of previous invasive breast cancer

- History of prior chemotherapy in the past 5 years

- History of prior trastuzumab or prior paclitaxel therapy

- Active, unresolved infection

- Active liver disease

- History of a different malignancy except for the following: disease free for at least
5 years and at low risk for recurrence; cervical cancer in situ, basal or squamous
cell carcinoma of the skin

- Active cardiac disease
We found this trial at
85
sites
Raleigh, North Carolina 27609
Principal Investigator: Katherine Reeder-Hayes, MD
Phone: 919-966-7828
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Steven Isakoff, MD, PhD
Phone: 617-726-4920
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Principal Investigator: Nadine Tung, MD
Phone: 617-667-7081
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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3840 Broadway
Fort Myers, Florida 33901
(239) 275-6400
Principal Investigator: Lowell Hart, MD
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2220 Pierce Ave
Nashville, Tennessee 37232
615-936-8422
Principal Investigator: Vandana G Abramson, MD
Vanderbilt-Ingram Cancer Center The Vanderbilt-Ingram Cancer Center, located in Nashville, Tenn., brings together the clinical...
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326 Washington Street
Norwich, Connecticut 06360
860-892-6936
Principal Investigator: Patricia DeFusco, MD
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1259 South Cedar Crest Boulevard
Allentown, Pennsylvania 18103
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Ann Arbor, Michigan 48109
Principal Investigator: Catherine Van Poznak, MD
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Baltimore, Maryland 21231
Principal Investigator: Antonio Wolff, MD
Phone: 410-614-4192
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136 Mountainview Blvd
Basking Ridge, New Jersey 7920
(908) 542-3000
Principal Investigator: Chau Dang, MD
Memorial Sloan-Kettering Cancer Center - Basking Ridge At Memorial Sloan Kettering Basking Ridge, we offer...
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Beaver, Pennsylvania 15143
Principal Investigator: Shannon Puhalla, MD
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Bethesda, Maryland 20817
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Boise, Idaho 83712
Principal Investigator: Dan Zuckerman, MD
Phone: 208-381-2711
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Sara Tolaney, MD, MPH
Phone: 617-632-2335
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Brewer, Maine 04412
Principal Investigator: Audrey M Garrett, MD
Phone: 207-973-7478
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129 Oneida Valley Road
Butler, Pennsylvania 16001
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Katherine Reeder-Hayes, MD
Phone: 919-966-7828
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
Principal Investigator: Rita Nanda, MD
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Ewa Mrozek, MD
Phone: 614-293-0069
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Commack, New York 11725
Principal Investigator: Chau Dang, MD
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Concord, New Hampshire 03301
Principal Investigator: Douglas Weckstein, MD
Phone: 800-339-6484
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Danvers, Massachusetts 01923
Principal Investigator: Therese Mulvey, MD
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: P. Kelly Marcom, MD
Phone: 919-660-1278
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Farrell, Pennsylvania 16121
Principal Investigator: Shannon Puhalla, MD
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Fruitland, Idaho 83619
Principal Investigator: Dan Zuckerman, MD
Phone: 208-381-2711
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Greensburg, Pennsylvania 15601
Principal Investigator: Shannon Puhalla, MD
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Greensburg, Pennsylvania 15642
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110 North Main Street
Greenville, Pennsylvania 16125
Principal Investigator: Shannon Puhalla, MD
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500 Westchester Avenue
Harrison, New York 10604
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
Principal Investigator: Patricia DeFusco, MD
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Hooksett, New Hampshire 03106
Principal Investigator: Douglas Weckstein, MD
Phone: 603-622-6484
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Houston, Texas 77030
Principal Investigator: Mothaffar Rimawi, MD
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Houston, Texas 77030
Principal Investigator: Mothaffar Rimawi, MD
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Houston, Texas 77030
Principal Investigator: Vicente Valero, MD
Phone: 713-563-0751
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Houston, Texas 77054
Principal Investigator: Mothaffar Rimawi, MD
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Indianapolis, Indiana 46202
Principal Investigator: Bryan Schneider, MD
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Indianapolis, Indiana 46202
Principal Investigator: Bryan Schneider, MD
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Indianapolis, Indiana 46202
Principal Investigator: Bryan Schneider, MD
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Indianapolis, Indiana 46290
Principal Investigator: Bryan Schneider, MD
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Jamaica, New York 11432
Principal Investigator: Margaret Kemeny, MD
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Jefferson Hills, Pennsylvania 15025
Principal Investigator: Shannon Puhalla, MD
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Johnstown, Pennsylvania 15905
Principal Investigator: Shannon Puhalla, MD
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Laconia, New Hampshire 03246
Principal Investigator: Douglas Weckstein, MD
Phone: 800-339-6484
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Lake Success, New York 11020
Principal Investigator: Kit Cheng, MD
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Londonderry, New Hampshire 03053
Principal Investigator: Frederick Briccetti, MD
Phone: 603-552-9100
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295 Varnum Ave
Lowell, Massachusetts 01854
(978) 937-6000
Principal Investigator: Blair Ardman, MD
Lowell General Hospital Welcome to Lowell General Hospital! Our goal is to provide you with...
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Lutherville, Maryland 21093
Principal Investigator: Antonio Wolff, MD
Phone: 410-614-4192
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Principal Investigator: Kathy Albain, MD
Phone: 708-327-3102
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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McKeesport, Pennsylvania 15132
Principal Investigator: Shannon Puhalla, MD
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Meriden, Connecticut 06451
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Meridian, Idaho 83642
Principal Investigator: Dan Zuckerman, MD
Phone: 208-381-2711
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Milford, Massachusetts 01757
Principal Investigator: Michael Constantine, MD
Phone: 508-488-3700
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Monroeville, Pennsylvania 15146
Principal Investigator: Shannon Puhalla, MD
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Mount Pleasant, Pennsylvania 15666
Principal Investigator: Shannon Puhalla, MD
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Nampa, Idaho 83686
Principal Investigator: Dan Zuckerman, MD
Phone: 208-381-2711
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Nashville, Tennessee 37203
Principal Investigator: Denise Yardley, MD
Phone: 877-691-7274
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New Britain, Connecticut 06050
Principal Investigator: Patricia DeFusco, MD
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New Castle, Pennsylvania 16105
Principal Investigator: Shannon Puhalla, MD
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New Lenox, Illinois 60451
Principal Investigator: Rita Nanda, MD
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1275 York Ave
New York, New York 10021
(212) 639-2000
Principal Investigator: Chau Dang, MD
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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Pittsburgh, Pennsylvania 15215
Principal Investigator: Shannon Puhalla, MD
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Shannon Puhalla, MD
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Shannon Puhalla, MD
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Pittsburgh, Pennsylvania 15232
Principal Investigator: Shannon Puhalla, MD
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Pittsburgh, Pennsylvania 15213
Principal Investigator: Shannon Puhalla, MD
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Rochester, Minnesota 55905
Principal Investigator: Minetta Liu, MD
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Rockville Centre, New York 11570
Principal Investigator: Chau Dang, MD
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Saint Louis, Missouri 63110
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Saint Louis, Missouri 63129
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10 Barnes West Drive
Saint Louis, Missouri 63141
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Peters, Missouri 63376
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Saint Petersburg, Florida 33705
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San Francisco, California 94143
Principal Investigator: Hope Rugo, MD
Phone: 415-353-7618
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Seattle, Washington 98109
Principal Investigator: Vijayakrishna Gadi, MD
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Seneca, Pennsylvania 16346
Principal Investigator: Shannon Puhalla, MD
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Seneca, Pennsylvania 16346
Principal Investigator: Shannon Puhalla, MD
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Sleepy Hollow, New York 10591
Principal Investigator: Chau Dang, MD
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Twin Falls, Idaho 83301
Principal Investigator: Dan Zuckerman, MD
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Washington, District of Columbia 20010
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5255 Loughboro Rd NW
Washington, District of Columbia 20016
(202) 537-4000
Sibley Memorial Hospital Sibley Memorial Hospital, in Northwest Washington, D.C., has a distinguished history of...
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Washington, Pennsylvania 15301
Principal Investigator: Shannon Puhalla, MD
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