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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started

Description

Summary

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.

Official Title

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)

Details

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.

Keywords

Breast Cancer Breast Neoplasms Paclitaxel Maytansine Ado-trastuzumab emtansine Albumin-Bound Paclitaxel Trastuzumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 </= 7 days) prior to 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

You CAN'T join if...

  • 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

Locations

  • University of California San Francisco
    San Francisco, California, 94115, United States
  • Mountain States Tumor Institute
    Twin Falls, Idaho, 83301, United States
  • Mountain States Tumor Institute
    Nampa, Idaho, 83686, United States
  • Mountain States Tumor Institute
    Meridian, Idaho, 83642, United States
  • Mountain States Tumor Institute
    Boise, Idaho, 83712, United States
  • Mountain States Tumor Institute
    Fruitland, Idaho, 83619, United States
  • University of Washington Seattle Cancer Care Alliance
    Seattle, Washington, 98109, United States
  • Baylor College of Medicine-Baylor Clinic
    Houston, Texas, 77030, United States
  • Harris County Hospital District-Ben Taub General Hospital
    Houston, Texas, 77030, United States
  • MD Anderson Cancer Center
    Houston, Texas, 77030, United States
  • Harris County Hospital District-Smith Clinic
    Houston, Texas, 77054, United States
  • Mayo Clinic
    Rochester, Minnesota, 55905, United States
  • Siteman Cancer Center - St. Peters
    Saint Peters, Missouri, 63376, United States
  • Siteman Cancer Center - West County
    Saint Louis, Missouri, 63141, United States
  • Siteman Cancer Center - South County
    Saint Louis, Missouri, 63129, United States
  • Barnes-Jewish Hospital
    Saint Louis, Missouri, 63110, United States
  • Washington University, School of Medicine
    Saint Louis, Missouri, 63110, United States
  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
    New Lenox, Illinois, 60451, United States
  • Loyola University Medical Center
    Maywood, Illinois, 60153, United States
  • University of Chicago Medical Center
    Chicago, Illinois, 60637, United States
  • Indiana University - Springmill Medical Clinic
    Indianapolis, Indiana, 46290, United States
  • Vanderbilt-Ingram Cancer Center
    Nashville, Tennessee, 37232, United States
  • Indiana University - Wishard Hospital
    Indianapolis, Indiana, 46202, United States
  • Indiana University Health - Melvin and Bren Simon Cancer Center
    Indianapolis, Indiana, 46202, United States
  • Indiana University Health - University Hospital
    Indianapolis, Indiana, 46202, United States
  • Tennessee Oncology/Sarah Cannon Research Institute
    Nashville, Tennessee, 37203, United States
  • University of Alabama Birmingham
    Birmingham, Alabama, 35249, United States
  • Univeristy of Michigan Health System
    Ann Arbor, Michigan, 48109, United States
  • The Ohio State University
    Columbus, Ohio, 43212, United States
  • UPMC Horizon (Shenango)
    Farrell, Pennsylvania, 16121, United States
  • UPMC Horizon (Greenville)
    Greenville, Pennsylvania, 16125, United States
  • UPMC Jameson Cancer Center
    New Castle, Pennsylvania, 16105, United States
  • UPMC and the Washington Hospital Center
    Washington, Pennsylvania, 15301, United States
  • UPMC/HVHS Cancer Center, UPMC Beaver
    Beaver, Pennsylvania, 15143, United States
  • UPMC Passavant
    Pittsburgh, Pennsylvania, 15237, United States
  • UPMC CancerCenters Butler
    Butler, Pennsylvania, 16001, United States
  • UPMC Cancer Center Jefferson Regional Med Ctr
    Jefferson Hills, Pennsylvania, 15025, United States
  • UPMC St. Margaret
    Pittsburgh, Pennsylvania, 15215, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania, 15232, United States
  • UPMC Cancer Center St. Clair Hospital
    Pittsburgh, Pennsylvania, 15232, United States
  • UPMC Presbyterian Shadyside
    Pittsburgh, Pennsylvania, 15232, United States
  • UPMC McKeesport
    McKeesport, Pennsylvania, 15132, United States
  • UPMC Northwest (Franklin)
    Seneca, Pennsylvania, 16346, United States
  • UPMC Northwest (Oil City)
    Seneca, Pennsylvania, 16346, United States
  • UPMC East
    Monroeville, Pennsylvania, 15146, United States
  • Arnold Palmer Medical Oncology Oakbrook
    North Huntingdon, Pennsylvania, 15642, United States
  • Arnold Palmer Cancer Center-Greensburg
    Greensburg, Pennsylvania, 15601, United States
  • Arnold Palmer Medical Oncology-Mt Pleasant
    Mount Pleasant, Pennsylvania, 15666, United States
  • UPMC Conemaugh Cancer Center
    Johnstown, Pennsylvania, 15905, United States
  • Florida Cancer Specialists
    Saint Petersburg, Florida, 337054, United States
  • University of North Carolina
    Chapel Hill, North Carolina, 27599, United States
  • Duke University Medical Center
    Durham, North Carolina, 27710, United States
  • Rex Cancer Center
    Raleigh, North Carolina, 27607, United States
  • Sibley Memorial Hospital
    Washington, D.C., District of Columbia, 20016, United States
  • Georgetown Hospital
    Washington, D.C., District of Columbia, 20007, United States
  • Washington Cancer Institute at Medstar Washington Hospital Center
    Washington, D.C., District of Columbia, 20010, United States
  • Florida Cancer Specialists
    Fort Myers, Florida, 33916, United States
  • Johns Hopkins - Green Spring Station
    Lutherville, Maryland, 21093, United States
  • Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
    Baltimore, Maryland, 21287, United States
  • Lehigh Valley Hospital/Lehigh Valley Health Network
    Allentown, Pennsylvania, 18103, United States
  • Memorial Sloan Kettering Cancer Center-Basking Ridge
    Basking Ridge, New Jersey, 07920, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York, 10065, United States
  • Memorial Sloan Kettering Cancer Center-West Harrison
    Harrison, New York, 10591, United States
  • Memorial Sloan Kettering Cancer Center-Sleepy Hollow
    Sleepy Hollow, New York, 10591, United States
  • Queens Hospital Center, Comprehensive Cancer Center
    Jamaica, New York, 11432, United States
  • North Shore-LIJ Health System/Monter Cancer Center
    Lake Success, New York, 11042, United States
  • Memorial Sloan Kettering Cancer Center-Mercy
    Rockville Centre, New York, 11570, United States
  • Memorial Sloan Kettering Cancer Center-Suffolk
    Commack, New York, 11725, United States
  • Midstate Medical Center
    Meriden, Connecticut, 06451, United States
  • Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut
    New Britain, Connecticut, 06050, United States
  • Hartford Hospital
    Hartford, Connecticut, 06102, United States
  • William W Backus Hospital
    Norwich, Connecticut, 06360, United States
  • New Hampshire Oncology-Hematology, PA
    Concord, New Hampshire, 03301, United States
  • New Hampshire Oncology-Hematology, PA
    Laconia, New Hampshire, 03246, United States
  • New Hampshire Oncology-Hematology, PA
    Hooksett, New Hampshire, 03106, United States
  • Dana-Farber Cancer Institute at Milford Hospital
    Milford, Massachusetts, 01757, United States
  • Dana-Farber Cancer Insitute at Londonderry Hospital
    Londonderry, New Hampshire, 03053, United States
  • Lowell General Hospital
    Lowell, Massachusetts, 01854, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts, 02215, United States
  • Dana-Farber Cancer Institute
    Boston, Massachusetts, 02215, United States
  • Massachusetts General Hospital
    Boston, Massachusetts, 02114, United States
  • Mass General North Shore Cancer Center
    Danvers, Massachusetts, 01923, United States
  • Eastern Maine Medical Center's Cancer Care
    Brewer, Maine, 04412, United States

Details

Status
in progress, not accepting new patients
Start Date
Sponsor
Dana-Farber Cancer Institute
ID
NCT01853748
Phase
Phase 2
Lead Scientist
Hope Rugo
Study Type
Interventional
Last Updated
October 18, 2017