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

Description

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.

Study Start Date

May 2013

Estimated Completion Date

May 2017

Interventions

  • Drug: Paclitaxel
  • Drug: Trastuzumab emtansine
  • Drug: Trastuzumab

Specialties

  • Obstetrics & Gynecology: Breast
  • Oncology: Breast,Pharmacology/Therapy
  • Pharmacy: Adverse Drug Reactions,Chemotherapy/Oncology,Drug Trials

MeSH Terms

  • Breast Neoplasms

Study ID

Dana-Farber Cancer Institute -- 13-048

Status

Unknown

Trial ID

NCT01853748

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

500

Sponsor

Dana-Farber Cancer Institute

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+ or FISH HER2/CEP17 >/= 2
  • 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
  • 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
  • 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 6 months after end of study treatment
  • Subjects who have undergone partial breast radiation (duration Subjects with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy
  • 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
  • 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (79)

Study Location Distance Name Phone Email
DanaFarber Cancer Institute - Boston, Massachusetts 2.4 miles Sara Tolaney MD MPH 617-632-2335 stolaney@partners.org
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Nadine Tung MD 617-667-7081 ntung@bidmc.harvard.edu
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Steven Isakoff MD PhD 617-726-4920 sisakoff@partners.org
Dana Farber Cancer Institute at Faulkner Hospital - Boston, Massachusetts 5.4 miles None None None
Mass General North Shore Cancer Center - Danvers, Massachusetts 16.4 miles Therese Mulvey MD None tmmulvey@partners.org
Lowell General Hospital - Lowell, Massachusetts 23.0 miles Blair Ardman MD None Blair.Ardman@lowellgeneral.org
DanaFarber Cancer Institute at Milford Hospital - Milford, Massachusetts 26.3 miles Michael Constantine MD 508-488-3700 mconstantine@partners.org
DanaFarber Cancer Insitute at Londonderry Hospital - Londonderry, New Hampshire 37.5 miles Frederick Briccetti MD 603-552-9100 fbriccetti@partners.org
New Hampshire OncologyHematology PA - Hooksett, New Hampshire 51.2 miles Douglas Weckstein MD 603-622-6484 d.weckstein@nhoh.com
New Hampshire OncologyHematology PA - Concord, New Hampshire 64.0 miles Douglas Weckstein MD 800-339-6484 d.weckstein@nhoh.com
William W Backus Hospital - Norwich, Connecticut 73.8 miles Patricia DeFusco MD None Patricia.DeFusco@hhchealth.org
New Hampshire OncologyHematology PA - Laconia, New Hampshire 83.8 miles Douglas Weckstein MD 800-339-6484 d.weckstein@nhoh.com
Hartford Hospital - Hartford, Connecticut 90.7 miles Patricia DeFusco MD None Patricia.DeFusco@hhchealth.org
Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut - New Britain, Connecticut 98.5 miles Patricia DeFusco MD None Patricia.DeFusco@hhchealth.org
Memorial Sloan Kettering Cancer CenterSuffolk - Commack, New York 154.4 miles Chau Dang MD None dangc@mskcc.org
Memorial Sloan Kettering Cancer CenterWest Harrison - West Harrison, New York 167.9 miles Chau Dang MD None dangc@mskcc.org
Memorial Sloan Kettering Cancer CenterSleepy Hollow - Sleepy Hollow, New York 167.9 miles Chau Dang MD None dangc@mskcc.org
North ShoreLIJ Health SystemMonter Cancer Center - Lake Success, New York 174.6 miles Kit Cheng MD None kcheng@nshs.edu
Memorial Sloan Kettering Cancer CenterMercy - Rockville Centre, New York 176.5 miles Chau Dang MD None dangc@mskcc.org
Queens Hospital Center Comprehensive Cancer Center - Jamaica, New York 180.3 miles Margaret Kemeny MD None kemenym@nychhc.org
Memorial Sloan Kettering Cancer Center - New York, New York 187.1 miles Chau Dang MD None dangc@mskcc.org
Eastern Maine Medical Centers Cancer Care - Brewer, Maine 205.1 miles Audrey M Garrett MD 207-973-7478 None
Memorial Sloan Kettering Cancer CenterBasking Ridge - Basking Ridge, New Jersey 214.0 miles Chau Dang MD None dangc@mskcc.org
Johns Hopkins Green Spring Station - Lutherville, Maryland 354.4 miles Antonio Wolff MD 410-614-4192 None
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center - Baltimore, Maryland 356.0 miles Antonio Wolff MD 410-614-4192 None
Sibley Memorial Hospital - Washington, District of Columbia 393.8 miles Antonio Wolff MD 410-614-4192 None
Suburban Hospital Cancer Program - Bethesda, Maryland 394.0 miles None None None
MedStar Georgetown University Hospital - Washington, District of Columbia 394.4 miles Paula Pohlmann MD None Paula.R.Pohlmann@gunet.georgetown.edu
UPMC Conemaugh Cancer Center - Johnstown, Pennsylvania 431.6 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC Northwest Oil City - Seneca, Pennsylvania 448.5 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC Northwest Franklin - Seneca, Pennsylvania 448.5 miles Shannon Puhalla MD None puhallasl@upmc.edu
Arnold Palmer Cancer CenterGreensburg - Greensburg, Pennsylvania 461.5 miles Shannon Puhalla MD None None
Arnold Palmer Medical OncologyMt Pleasant - Mount Pleasant, Pennsylvania 465.1 miles Shannon Puhalla MD None puhallasl@upmc.edu
Arnold Palmer Medical Oncology Oakbrook - North Huntingdon, Pennsylvania 469.4 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC St Margaret - Pittsburgh, Pennsylvania 475.0 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC McKeesport - McKeesport, Pennsylvania 475.2 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC East - Monroeville, Pennsylvania 476.5 miles Shannon Puhalla MD None puhallasl@upmc.edu
University of Pittsburgh Medical Center - Pittsburgh, Pennsylvania 477.2 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC Presbyterian Shadyside - Pittsburgh, Pennsylvania 477.2 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC Cancer Center St Clair Hospital - Pittsburgh, Pennsylvania 477.2 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC Cancer Center Jefferson Regional Med Ctr - Jefferson Hills, Pennsylvania 479.9 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC Passavant - Pittsburgh, Pennsylvania 480.1 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC Horizon Greenville - Greenville, Pennsylvania 482.2 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMCHVHS Cancer Center UPMC Beaver - Beaver, Pennsylvania 486.0 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC Jameson Cancer Center - New Castle, Pennsylvania 486.4 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC Horizon Shenango - Farrell, Pennsylvania 491.1 miles Shannon Puhalla MD None puhallasl@upmc.edu
UPMC and the Washington Hospital Center - Washington, Pennsylvania 499.6 miles Shannon Puhalla MD None puhallasl@upmc.edu
Duke University Medical Center - Durham, North Carolina 609.0 miles P Kelly Marcom MD 919-660-1278 breastcl@dm.duke.edu
Rex Cancer Center - Raleigh, North Carolina 610.5 miles Katherine ReederHayes MD 919-966-7828 None
University of North Carolina - Chapel Hill, North Carolina 616.4 miles Katherine ReederHayes MD 919-966-7828 None
The Ohio State University - Columbus, Ohio 643.4 miles Ewa Mrozek MD 614-293-0069 None
Univeristy of Michigan Health System - Ann Arbor, Michigan 645.2 miles Catherine Van Poznak MD None cvanpoz@med.umich.edu
Indiana University Springmill Medical Clinic - Indianapolis, Indiana 804.6 miles Bryan Schneider MD None bpschnei@iupui.edu
Indiana University Wishard Hospital - Indianapolis, Indiana 805.0 miles Bryan Schneider MD None bpschnei@iupui.edu
Indiana University Health Melvin and Bren Simon Cancer Center - Indianapolis, Indiana 805.0 miles Bryan Schneider MD None bpschnei@iupui.edu
Indiana University Health University Hospital - Indianapolis, Indiana 805.0 miles Bryan Schneider MD None bpschnei@iupui.edu
University of Chicago Medical Center - Chicago, Illinois 848.0 miles Rita Nanda MD None rnanda@medicine.bsd.uchicago.edu
Loyola University Medical Center - Maywood, Illinois 859.6 miles Kathy Albain MD 708-327-3102 None
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital - New Lenox, Illinois 869.4 miles Rita Nanda MD None rnanda@medicine.bsd.uchicago.edu
Tennessee OncologySarah Cannon Research Institute - Nashville, Tennessee 942.8 miles Denise Yardley MD 877-691-7274 dyardley@tnonc.com
VanderbiltIngram Cancer Center - Nashville, Tennessee 944.2 miles Vandana G Abramson MD None vandana.abramson@vanderbilt.edu
BarnesJewish Hospital - St. Louis, Missouri 1,039.5 miles Ron Bose MD 314-362-8903 None
Washington University School of Medicine - St. Louis, Missouri 1,039.5 miles Ron Bose MD 314-362-8903 None
Siteman Cancer Center South County - St. Louis, Missouri 1,047.0 miles Ron Bose MD 314-362-8903 None
Siteman Cancer Center West County - St. Louis, Missouri 1,048.4 miles Ron Bose MD 314-362-8903 None
Siteman Cancer Center St Peters - St. Peters, Missouri 1,054.0 miles Ron Bose MD 314-362-8903 None
Mayo Clinic - Rochester, Minnesota 1,083.1 miles Minetta Liu MD None Liu.Minetta@mayo.edu
Florida Cancer Specialists - Fort Myers, Florida 1,247.9 miles Lowell Hart MD None None
MD Anderson Cancer Center - Houston, Texas 1,609.9 miles Vicente Valero MD 713-563-0751 vvalero@mdanderson.org
Harris County Hospital DistrictBen Taub General Hospital - Houston, Texas 1,609.9 miles Mothaffar Rimawi MD None rimawi@bcm.edu
Baylor College of MedicineBaylor Clinic - Houston, Texas 1,609.9 miles Mothaffar Rimawi MD None rimawi@bcm.edu
Harris County Hospital DistrictSmith Clinic - Houston, Texas 1,610.9 miles Mothaffar Rimawi MD None rimawi@bcm.edu
Mountain States Tumor Institute - Twin Falls, Idaho 2,196.8 miles Dan Zuckerman MD 208-381-2711 zuckermd@slhs.org
Mountain States Tumor Institute - Boise, Idaho 2,256.8 miles Dan Zuckerman MD 208-381-2711 zuckermd@slhs.org
Mountain States Tumor Institute - Meridian, Idaho 2,268.1 miles Dan Zuckerman MD 208-381-2711 zuckermd@slhs.org
Mountain States Tumor Institute - Nampa, Idaho 2,277.9 miles Dan Zuckerman MD 208-381-2711 zuckermd@slhs.org
Mountain States Tumor Institute - Fruitland, Idaho 2,286.7 miles Dan Zuckerman MD 208-381-2711 zuckermd@slhs.org
University of Washington Seattle Cancer Care Alliance - Seattle, Washington 2,490.2 miles Vijayakrishna Gadi MD None vkgadi@u.washington.edu
University of California San Francisco - San Francisco, California 2,698.0 miles Hope Rugo MD 415-353-7618 hrugo@medicine.ucsf.edu

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