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AzTrials

Breast CancerPhase 2NCT01853748

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

A Phase 2 study testing Trastuzumab, Paclitaxel and Trastuzumab emtansine in people with Breast Cancer, run by Dana-Farber Cancer Institute at 85 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab, Paclitaxel and Trastuzumab emtansine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
512 participants
Where
85 sitesUnited States
Study dates
May 2013to 15 Jun 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

85 sites in 1 country.

85 sites in 1 country

United States85 sites

  • Lehigh Valley Hospital/Lehigh Valley Health Network

    Allentown, Pennsylvania, 18103

  • Univeristy of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

  • Memorial Sloan Kettering Cancer Center-Basking Ridge

    Basking Ridge, New Jersey, 07920

  • UPMC/HVHS Cancer Center, UPMC Beaver

    Beaver, Pennsylvania, 15143

  • Suburban Hospital Cancer Program

    Bethesda, Maryland, 20817

  • University of Alabama Birmingham

    Birmingham, Alabama, 35249

  • Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute at Faulkner Hospital

    Boston, Massachusetts, 02130

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Eastern Maine Medical Center's Cancer Care

    Brewer, Maine, 04412

  • UPMC CancerCenters Butler

    Butler, Pennsylvania, 16001

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Siteman Cancer Center - St. Peters

    City of Saint Peters, Missouri, 63376

  • The Ohio State University

    Columbus, Ohio, 43212

  • Memorial Sloan Kettering Cancer Center-Suffolk

    Commack, New York, 11725

  • New Hampshire Oncology-Hematology, PA

    Concord, New Hampshire, 03301

  • Mass General North Shore Cancer Center

    Danvers, Massachusetts, 01923

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Memorial Sloan Kettering Cancer Center Westchester

    East White Plains, New York, 10604

  • UPMC Horizon (Shenango)

    Farrell, Pennsylvania, 16121

  • Florida Cancer Specialists

    Fort Myers, Florida, 33916

  • Mountain States Tumor Institute

    Fruitland, Idaho, 83619

  • Arnold Palmer Cancer Center-Greensburg

    Greensburg, Pennsylvania, 15601

  • Arnold Palmer Medical Oncology Oakbrook

    Greensburg, Pennsylvania, 15642

  • UPMC Horizon (Greenville)

    Greenville, Pennsylvania, 16125

  • UPMC Pinnacle Harrisburg

    Harrisburg, Pennsylvania, 17101

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • New Hampshire Oncology-Hematology, PA

    Hooksett, New Hampshire, 03106

  • Baylor College of Medicine-Baylor Clinic

    Houston, Texas, 77030

  • Harris County Hospital District-Ben Taub General Hospital

    Houston, Texas, 77030

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Harris County Hospital District-Smith Clinic

    Houston, Texas, 77054

  • Indiana University - Wishard Hospital

    Indianapolis, Indiana, 46202

  • Indiana University Health - Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Indiana University Health - University Hospital

    Indianapolis, Indiana, 46202

  • Indiana University - Springmill Medical Clinic

    Indianapolis, Indiana, 46290

  • Queens Hospital Center, Comprehensive Cancer Center

    Jamaica, New York, 11432

  • UPMC Cancer Center Jefferson Regional Med Ctr

    Jefferson Hills, Pennsylvania, 15025

  • UPMC Conemaugh Cancer Center

    Johnstown, Pennsylvania, 15905

  • New Hampshire Oncology-Hematology, PA

    Laconia, New Hampshire, 03246

  • Northwell Health/Monter Cancer Center

    Lake Success, New York, 11042

  • Dana-Farber Cancer Insitute at Londonderry Hospital

    Londonderry, New Hampshire, 03053

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Johns Hopkins - Green Spring Station

    Lutherville, Maryland, 21093

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • UPMC McKeesport

    McKeesport, Pennsylvania, 15132

  • Midstate Medical Center

    Meriden, Connecticut, 06451

  • Mountain States Tumor Institute

    Meridian, Idaho, 83642

  • Dana-Farber Cancer Institute at Milford Hospital

    Milford, Massachusetts, 01757

  • UPMC East

    Monroeville, Pennsylvania, 15146

  • Arnold Palmer Medical Oncology-Mt Pleasant

    Mount Pleasant, Pennsylvania, 15666

  • Mountain States Tumor Institute

    Nampa, Idaho, 83686

  • Tennessee Oncology/Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • UPMC Jameson Cancer Center

    New Castle, Pennsylvania, 16105

  • University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

    New Lenox, Illinois, 60451

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • William W Backus Hospital

    Norwich, Connecticut, 06360

  • University of Chicago Medical Center for Advanced Care Orland Park

    Orland Park, Illinois, 60462

  • UPMC St. Margaret

    Pittsburgh, Pennsylvania, 15215

  • UPMC Cancer Center St. Clair Hospital

    Pittsburgh, Pennsylvania, 15232

  • UPMC Presbyterian Shadyside

    Pittsburgh, Pennsylvania, 15232

  • UPMC Passavant

    Pittsburgh, Pennsylvania, 15237

  • Rex Cancer Center

    Raleigh, North Carolina, 27607

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Memorial Sloan Kettering Cancer Center-Mercy

    Rockville Centre, New York, 11570

  • University of California San Francisco

    San Francisco, California, 94115

  • University of Washington Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • UPMC Northwest (Franklin)

    Seneca, Pennsylvania, 16346

  • UPMC Northwest (Oil City)

    Seneca, Pennsylvania, 16346

  • Memorial Sloan Kettering Cancer Center-Sleepy Hollow

    Sleepy Hollow, New York, 10591

  • Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Washington University, School of Medicine

    St Louis, Missouri, 63110

  • Siteman Cancer Center - South County

    St Louis, Missouri, 63129

  • Siteman Cancer Center - West County

    St Louis, Missouri, 63141

  • Florida Cancer Specialists

    St. Petersburg, Florida, 337054

  • Mountain States Tumor Institute

    Twin Falls, Idaho, 83301

  • UPMC and the Washington Hospital Center

    Washington, Pennsylvania, 15301

  • Georgetown Hospital

    Washington D.C., District of Columbia, 20007

  • Washington Cancer Institute at Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

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)

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.

Read the detailed description

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.

Conditions
Breast Cancer
Being tested
Trastuzumab, Paclitaxel, Trastuzumab emtansine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01853748
Study groupRoleWhat they receive
Trastuzumab emtansine (T-DM1)Active comparatorT-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks
Receives: Drug: Trastuzumab emtansine
Paclitaxel + TrastuzumabActive comparatorpaclitaxel 80 mg/m2 IV weekly and trastuzumab 4 mg/kg IV load, followed by 2 mg/kg IV weekly for 12 weeks, followed by trastuzumab 6 mg/kg IV every 3 weeks for 13 treatments
Receives: Drug: Trastuzumab; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants of Clinically Relevant Toxicities (CRT)

    Clinically relevant toxicities will include the composite incidence of grade 3 or higher non-hematologic toxicity, grade 2 or higher neurotoxicity, and grade 4 or higher hematologic toxicity. These toxicities will only be assessed at the pre-specified toxicity-assessment visits. In addition, the following events, regardless of timing of their occurrence, will also count towards the composite endpoint: febrile neutropenia, any toxicity requiring dose-delay, discontinuation of any study treatment (Paclitaxel, Trastuzumab, or T-DM1) for toxicity, and any serious adverse event (SAE).

    Measured: 5 years after completion of study treatment or until death, whichever occurs first.

  2. 3-year Disease Free Survival (DFS) Rate of Trastuzumab Emtansine (TDM-1)

    Disease-free survival (DFS) is evaluated and defined per protocol: from the time of randomization until the to the occurrence of the first of the following events:

    • Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast.
    • Contralateral invasive breast cancer,
    • Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description.
    • Death from any cause

    Measured: 3 years

Secondary outcomes (21)

  1. Incidence Rate of Grade 3-4 Treatment-Related Toxicity

    All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade >=3 AE of any type during the time of observation.

    Measured: AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.

  2. Quality of Life (QOL) FACT B Total Score at Baseline

    The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below:

    Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).

    Measured: at baseline

  3. Quality of Life (QOL) FACT B Total Score at Week 3

    The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below:

    Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).

    Measured: at week 3

  4. Quality of Life (QOL) FACT B Total Score at Week 12

    The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below:

    Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).

    Measured: at week 12

  5. Quality of Life (QOL) FACT B Total Score at 6 Months

    The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below:

    Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).

    Measured: at 6 months

  6. Quality of Life (QOL) FACT B Total Score at 1 Year

    The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below:

    Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).

    Measured: at 1 year

  7. Quality of Life (QOL) FACT B Total Score at 18 Months

    The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below:

    Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).

    Measured: at 18 months

  8. Quality of Life (QOL) FACT B Total Score at 24 Months

    The QOL assessments questionnaire should be completed via the tablet provided by the study or on any available computer with an internet connection. The FACT-B questionnaire consists of five subscale, listed below:

    Physical well being(PWB): range 0-28 Social/Family well being(SWB): range 0-28 Emotional well being(EWB): range 0-24 Functional well being(FWB): range 0-28 Breast cancer subscale(BCS): range 0-40 The total score (FACTB) is calculated by summarizing all the subscales listed above, therefore it ranges from 0 to 148. The higher the score the better the outcome (applies to all sub-scales as well).

    Measured: at 24 months

  9. Number of Patients Has Neuropathy

    Neuropathy evaluated by Patient Neurotoxicity Questionnaire (PNQ) defined per protocol.

    Measured: Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18. The data cutoff date is 18 month.

  10. Percentage of Work Time Missed Because of Health

    Effects of therapy on work productivity and activity - work time missed because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.

    Measured: Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

  11. Percentage of Impairment While Working Because of Health (Mean, SD)

    Effects of therapy on work productivity and activity - Impairment While Working because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.

    Measured: Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

  12. Percentage of Overall Work Impairment Because of Health

    Effects of therapy on work productivity and activity - Work Impairment because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.

    Measured: Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

  13. Percentage of Activity Impairment Because of Health

    Effects of therapy on work productivity and activity - Activity Impairment because of health, evaluated using the Work Productivity and Activity Impairment Questionnaire (WPAI-SHP), which defined per protocol.

    Measured: Surveys are took at week 3, 12 and month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

  14. Number of Patients Have Alopecia

    alopecia assessment is a 5-item questionnaire that will assess the impact alopecia has had on these patients and will be conducted electronically at pre-specified study visits. If electronic evaluation is not possible, paper evaluation will be conducted.

    Measured: Median follow-up was 3.9 years. The AE data cutoff date is 21 April 2020.

  15. 3-year T-DM1 iDFS Percentage by Tumor Size and Hormone Receptor (HR) Status

    Disease-free survival (DFS) is evaluated in patients treated with trastuzumab emtansine, which is defined per protocol: from the time of randomization until the to the occurrence of the first of the following events:

    • Local/regional recurrence: a recurrent or new invasive ipsilateral breast cancer, invasive breast cancer in the axilla, regional lymph nodes, chest wall, or skin of the ipsilateral breast.
    • Contralateral invasive breast cancer,
    • Distant recurrence: metastatic disease that has either been biopsy confirmed or clinically diagnosed as recurrent invasive breast cancer. A single new lesion on a bone scan without evidence of lytic disease on x-ray and without symptoms does not in and of itself constitute distant recurrence, but multiple new bone lesions, or increased isotope uptake associated with new bone symptoms are more likely due to metastases. Bone metastases must be documented with x-rays and clinical description.
    • Death from any cause

    Measured: 3 years

  16. Number of Incidence of Grade 3-4 Cardiac Left Ventricular Dysfunction

    All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade >=3 AE of any type during the time of observation

    Measured: AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.

  17. Number of Incidence of T-DM1 Induced Grade 2-3 Thrombocytopenia

    Reversible Grade 1-4 thrombocytopenia has been observed in ongoing studies with trastuzumab emtansine.

    Measured: AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first. Median follow-up 3.1 years.

  18. Number of SNPs With Top Associations of Trastuzumab Emtansine-induced Grade 2-4 Thrombocytopenia in the T-DM1 Arm

    DNA will be genotyped for SNPs and CNV markers using the Infinium Human Omni1 array (1.2 million SNP platform) from Illumina. A gene-based association analyses for thrombocytopenia or bleeding is applied with significancy (p-value). This analysis was only conducted in the T-DM1 arm.

    Measured: DNA sample collected at pre-treatment. AE is reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks.

  19. Percentage of Patients With Amenorrhea

    All grade 3 - 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv4 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade >=3 AE of any type during the time of observation.

    For those who were premenopausal pre-chemotherapy, at each follow-up visit (every six months) in order to assess for duration of amenorrhea and also premature ovarian failure.

    Measured: Surveys are took at month 6 and 12 during treatment, and month 18, 24, 30 and 36 during follow up.

  20. Gene Mutation Assessed Using High-throughput Mutation Profiling System (Oncomap)

    Archival tumor tissue from all patients will be assessed using a high-throughput mutation profiling system (Oncomap) to query a large panel of cancer gene mutations.

    Measured: After treatment

  21. Median Overall Survival (OS)

    OS is evaluated in patients with Stage I HER2-positive breast cancer treated with trastuzumab emtansine

    Measured: Reported every 3 weeks for the first 12 weeks, then every 9 weeks for the subsequent 39 weeks, then follow-up up to 5 years after completion of study treatment or until death, whichever occurs first.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completion26 Aug 2019
  4. Study completion15 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
512 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01853748
Sponsor's protocol ID
13-048
Status last verified
Feb 2026
First submitted
24 Apr 2013
Last updated
19 Feb 2026
Data monitoring committee
Yes

Publications

  • Tarantino P, Tayob N, Villacampa G, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Garrett AM, Marcom PK, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu MC, Ruddy KJ, Waks AG, DeMeo M, Burstein HJ, Partridge AH, Dell'Orto P, Russo L, Krause E, Newhouse DJ, Kurt BB, Mittendorf EA, Schneider B, Prat A, Winer EP, Krop IE, Tolaney SM; Consortium of the TBCRC Translational Investigators; TBCRC Translational Investigators. Adjuvant Trastuzumab Emtansine Versus Paclitaxel Plus Trastuzumab for Stage I Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: 5-Year Results and Correlative Analyses From ATEMPT. J Clin Oncol. 2024 Nov;42(31):3652-3665. doi: 10.1200/JCO.23.02170. Epub 2024 Jun 27.

    PubMed 38935923

  • Sella T, Zheng Y, Tayob N, Ruddy KJ, Freedman RA, Dang C, Yardley D, Isakoff SJ, Valero V, DeMeo M, Burstein HJ, Winer EP, Wolff AC, Krop I, Partridge AH, Tolaney SM. Treatment discontinuation, patient-reported toxicities and quality-of-life by age following trastuzumab emtansine or paclitaxel/trastuzumab (ATEMPT). NPJ Breast Cancer. 2022 Nov 30;8(1):127. doi: 10.1038/s41523-022-00495-x.

    PubMed 36450763

  • Barroso-Sousa R, Tarantino P, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, Faggen M, Mulvey T, Bose R, Hu J, Weckstein D, Wolff AC, Reeder-Hayes K, Rugo HS, Ramaswamy B, Zuckerman D, Hart L, Gadi VK, Constantine M, Cheng K, Briccetti F, Schneider B, Garrett AM, Marcom K, Albain K, DeFusco P, Tung N, Ardman B, Nanda R, Jankowitz RC, Rimawi M, Abramson V, Pohlmann PR, Van Poznak C, Forero-Torres A, Liu M, Ruddy KJ, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I, Tolaney SM. Cardiac outcomes of subjects on adjuvant trastuzumab emtansine vs paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT) study (TBCRC033): a randomized controlled trial. NPJ Breast Cancer. 2022 Feb 16;8(1):18. doi: 10.1038/s41523-022-00385-2.

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Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab, Paclitaxel and Trastuzumab emtansine in people with Breast Cancer, run by Dana-Farber Cancer Institute at 85 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants of Clinically Relevant Toxicities (CRT) (time frame: 5 years after completion of study treatment or until death, whichever occurs first.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01853748, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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