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New drug combo may offer fewer side effects for early breast cancer patients

NCT ID NCT01853748

Disease control Sponsor: Dana-Farber Cancer Institute Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether a drug called T-DM1 causes fewer side effects than the standard treatment of paclitaxel plus trastuzumab in people with stage I HER2-positive breast cancer. About 500 participants were randomly assigned to one of the two treatments. The researchers also tracked how long participants remained cancer-free after treatment. The goal was to find a gentler but effective option for early-stage disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

512 people

The number who actually took part.

Start date

May 2013

Finished

Jun 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \</= 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 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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Arnold Palmer Cancer Center-Greensburg

    Greensburg, Pennsylvania, 15601, United States

  • Arnold Palmer Medical Oncology Oakbrook

    Greensburg, Pennsylvania, 15642, United States

  • Arnold Palmer Medical Oncology-Mt Pleasant

    Mount Pleasant, Pennsylvania, 15666, United States

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110, United States

  • Baylor College of Medicine-Baylor Clinic

    Houston, Texas, 77030, United States

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215, United States

  • Dana Farber Cancer Institute at Faulkner Hospital

    Boston, Massachusetts, 02130, United States

  • Dana-Farber Cancer Insitute at Londonderry Hospital

    Londonderry, New Hampshire, 03053, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute at Milford Hospital

    Milford, Massachusetts, 01757, United States

  • Duke University Medical Center

    Durham, North Carolina, 27710, United States

  • Eastern Maine Medical Center's Cancer Care

    Brewer, Maine, 04412, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916, United States

  • Florida Cancer Specialists

    St. Petersburg, Florida, 337054, United States

  • Georgetown Hospital

    Washington D.C., District of Columbia, 20007, United States

  • Harris County Hospital District-Ben Taub General Hospital

    Houston, Texas, 77030, United States

  • Harris County Hospital District-Smith Clinic

    Houston, Texas, 77054, 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

  • Indiana University - Springmill Medical Clinic

    Indianapolis, Indiana, 46290, 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

  • 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

  • Lowell General Hospital

    Lowell, Massachusetts, 01854, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Mass General North Shore Cancer Center

    Danvers, Massachusetts, 01923, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center Westchester

    East White Plains, New York, 10604, United States

  • Memorial Sloan Kettering Cancer Center-Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Cancer Center-Mercy

    Rockville Centre, New York, 11570, United States

  • Memorial Sloan Kettering Cancer Center-Sleepy Hollow

    Sleepy Hollow, New York, 10591, United States

  • Memorial Sloan Kettering Cancer Center-Suffolk

    Commack, New York, 11725, United States

  • Midstate Medical Center

    Meriden, Connecticut, 06451, United States

  • Mountain States Tumor Institute

    Boise, Idaho, 83712, United States

  • Mountain States Tumor Institute

    Fruitland, Idaho, 83619, United States

  • Mountain States Tumor Institute

    Meridian, Idaho, 83642, United States

  • Mountain States Tumor Institute

    Nampa, Idaho, 83686, United States

  • Mountain States Tumor Institute

    Twin Falls, Idaho, 83301, United States

  • New Hampshire Oncology-Hematology, PA

    Concord, New Hampshire, 03301, United States

  • New Hampshire Oncology-Hematology, PA

    Hooksett, New Hampshire, 03106, United States

  • New Hampshire Oncology-Hematology, PA

    Laconia, New Hampshire, 03246, United States

  • Northwell Health/Monter Cancer Center

    Lake Success, New York, 11042, United States

  • Queens Hospital Center, Comprehensive Cancer Center

    Jamaica, New York, 11432, United States

  • Rex Cancer Center

    Raleigh, North Carolina, 27607, United States

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016, United States

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129, United States

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376, United States

  • Siteman Cancer Center - West County

    St Louis, Missouri, 63141, United States

  • Suburban Hospital Cancer Program

    Bethesda, Maryland, 20817, United States

  • Tennessee Oncology/Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • The Ohio State University

    Columbus, Ohio, 43212, United States

  • UPMC Cancer Center Jefferson Regional Med Ctr

    Jefferson Hills, Pennsylvania, 15025, United States

  • UPMC Cancer Center St. Clair Hospital

    Pittsburgh, Pennsylvania, 15232, United States

  • UPMC CancerCenters Butler

    Butler, Pennsylvania, 16001, United States

  • UPMC Conemaugh Cancer Center

    Johnstown, Pennsylvania, 15905, United States

  • UPMC East

    Monroeville, Pennsylvania, 15146, United States

  • UPMC Horizon (Greenville)

    Greenville, Pennsylvania, 16125, United States

  • UPMC Horizon (Shenango)

    Farrell, Pennsylvania, 16121, United States

  • UPMC Jameson Cancer Center

    New Castle, Pennsylvania, 16105, 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 Passavant

    Pittsburgh, Pennsylvania, 15237, United States

  • UPMC Pinnacle Harrisburg

    Harrisburg, Pennsylvania, 17101, United States

  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania, 15232, United States

  • UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215, United States

  • UPMC and the Washington Hospital Center

    Washington, Pennsylvania, 15301, United States

  • UPMC/HVHS Cancer Center, UPMC Beaver

    Beaver, Pennsylvania, 15143, United States

  • Univeristy of Michigan Health System

    Ann Arbor, Michigan, 48109, United States

  • University of Alabama Birmingham

    Birmingham, Alabama, 35249, United States

  • University of California San Francisco

    San Francisco, California, 94115, United States

  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

    New Lenox, Illinois, 60451, United States

  • University of Chicago Medical Center for Advanced Care Orland Park

    Orland Park, Illinois, 60462, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

  • University of Washington Seattle Cancer Care Alliance

    Seattle, Washington, 98109, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

  • Washington Cancer Institute at Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Washington University, School of Medicine

    St Louis, Missouri, 63110, United States

  • William W Backus Hospital

    Norwich, Connecticut, 06360, United States

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