Back to results

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

Primary Purpose

Breast Cancer

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Trastuzumab

Paclitaxel

Trastuzumab emtansine

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Alabama Birmingham
University of California San Francisco
Hartford Hospital
Midstate Medical Center
Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut
William W Backus Hospital
Georgetown Hospital
Washington Cancer Institute at Medstar Washington Hospital Center
Sibley Memorial Hospital
Florida Cancer Specialists
Florida Cancer Specialists
Mountain States Tumor Institute
Mountain States Tumor Institute
Mountain States Tumor Institute
Mountain States Tumor Institute
Mountain States Tumor Institute
Loyola University Medical Center
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
University of Chicago Medical Center for Advanced Care Orland Park
Indiana University - Wishard Hospital
Indiana University Health - Melvin and Bren Simon Cancer Center
Indiana University Health - University Hospital
Indiana University - Springmill Medical Clinic
Eastern Maine Medical Center's Cancer Care
Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center
Suburban Hospital Cancer Program
Johns Hopkins - Green Spring Station
Massachusetts General Hospital
Dana Farber Cancer Institute at Faulkner Hospital
Beth Israel Deaconess Medical Center
Dana-Farber Cancer Institute
Mass General North Shore Cancer Center
Lowell General Hospital
Dana-Farber Cancer Institute at Milford Hospital
Univeristy of Michigan Health System
Mayo Clinic
Barnes-Jewish Hospital
Washington University, School of Medicine
Siteman Cancer Center - South County
Siteman Cancer Center - West County
Siteman Cancer Center - St. Peters
New Hampshire Oncology-Hematology, PA
New Hampshire Oncology-Hematology, PA
New Hampshire Oncology-Hematology, PA
Dana-Farber Cancer Insitute at Londonderry Hospital
Memorial Sloan Kettering Cancer Center-Basking Ridge
Memorial Sloan Kettering Cancer Center-Suffolk
Memorial Sloan Kettering Cancer Center Westchester
Queens Hospital Center, Comprehensive Cancer Center
Northwell Health/Monter Cancer Center
Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center-Mercy
Memorial Sloan Kettering Cancer Center-Sleepy Hollow
University of North Carolina
Duke University Medical Center
Rex Cancer Center
The Ohio State University
Lehigh Valley Hospital/Lehigh Valley Health Network
UPMC/HVHS Cancer Center, UPMC Beaver
UPMC CancerCenters Butler
UPMC Horizon (Shenango)
Arnold Palmer Cancer Center-Greensburg
Arnold Palmer Medical Oncology Oakbrook
UPMC Horizon (Greenville)
UPMC Pinnacle Harrisburg
UPMC Cancer Center Jefferson Regional Med Ctr
UPMC Conemaugh Cancer Center
UPMC McKeesport
UPMC East
Arnold Palmer Medical Oncology-Mt Pleasant
UPMC Jameson Cancer Center
UPMC St. Margaret
UPMC Cancer Center St. Clair Hospital
UPMC Presbyterian Shadyside
UPMC Passavant
UPMC Northwest (Franklin)
UPMC Northwest (Oil City)
UPMC and the Washington Hospital Center
Tennessee Oncology/Sarah Cannon Research Institute
Vanderbilt-Ingram Cancer Center
Baylor College of Medicine-Baylor Clinic
Harris County Hospital District-Ben Taub General Hospital
MD Anderson Cancer Center
Harris County Hospital District-Smith Clinic
University of Washington Seattle Cancer Care Alliance

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Trastuzumab emtansine (T-DM1)

Paclitaxel + Trastuzumab

Arm Description

T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks

paclitaxel 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

Outcomes

Primary Outcome Measures

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).

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

Secondary Outcome Measures

Incidence Rate of Grade 3-4 Treatment-Related Toxicity

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).

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

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

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

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

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

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

Number of Patients Has Neuropathy

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

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.

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.

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.

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.

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.

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

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

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.

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.

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.

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.

Median Overall Survival (OS)

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

Full Information

NCT ID

NCT01853748

First Posted

April 24, 2013

Last Updated

January 9, 2023

Sponsor

Dana-Farber Cancer Institute

1. Study Identification

Unique Protocol Identification Number

NCT01853748

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 2013 (undefined)

Primary Completion Date

August 26, 2019 (Actual)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Dana-Farber Cancer Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

512 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Trastuzumab emtansine (T-DM1)

Arm Type

Active Comparator

Arm Description

T-DM1 3.6mg/kg every three weeks by IV for 17 doses for a total of 51 weeks

Arm Title

Paclitaxel + Trastuzumab

Arm Type

Active Comparator

Arm Description

paclitaxel 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

Intervention Type

Drug

Intervention Name(s)

Trastuzumab

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Type

Drug

Intervention Name(s)

Trastuzumab emtansine

Other Intervention Name(s)

T-DM1

Primary Outcome Measure Information:

Title

Number of Participants of Clinically Relevant Toxicities (CRT)

Description

Time Frame

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

Title

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

Description

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Incidence Rate of Grade 3-4 Treatment-Related Toxicity

Description

Time Frame

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.

Title

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

Description

Time Frame

at baseline

Title

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

Description

Time Frame

at week 3

Title

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

Description

Time Frame

at week 12

Title

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

Description

Time Frame

at 6 months

Title

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

Description

Time Frame

at 1 year

Title

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

Description

Time Frame

at 18 months

Title

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

Description

Time Frame

at 24 months

Title

Number of Patients Has Neuropathy

Description

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

Time Frame

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

Title

Percentage of Work Time Missed Because of Health

Description

Time Frame

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

Title

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

Description

Time Frame

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

Title

Percentage of Overall Work Impairment Because of Health

Description

Time Frame

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

Title

Percentage of Activity Impairment Because of Health

Description

Time Frame

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

Title

Number of Patients Have Alopecia

Description

Time Frame

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

Title

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

Description

Time Frame

3 years

Title

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

Description

Time Frame

Title

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

Description

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

Time Frame

Title

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

Description

Time Frame

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.

Title

Percentage of Patients With Amenorrhea

Description

Time Frame

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

Title

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

Description

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.

Time Frame

After treatment

Title

Median Overall Survival (OS)

Description

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

Time Frame

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sara Tolaney, MD, MPH

Organizational Affiliation

Dana-Farber Cancer Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35249

Country

United States

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

Hartford Hospital

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06102

Country

United States

Facility Name

Midstate Medical Center

City

Meriden

State/Province

Connecticut

ZIP/Postal Code

06451

Country

United States

Facility Name

Hartford Healthcare Cancer Institute at The Hospital of Central Connecticut

City

New Britain

State/Province

Connecticut

ZIP/Postal Code

06050

Country

United States

Facility Name

William W Backus Hospital

City

Norwich

State/Province

Connecticut

ZIP/Postal Code

06360

Country

United States

Facility Name

Georgetown Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Washington Cancer Institute at Medstar Washington Hospital Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Sibley Memorial Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20016

Country

United States

Facility Name

Florida Cancer Specialists

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33916

Country

United States

Facility Name

Florida Cancer Specialists

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

337054

Country

United States

Facility Name

Mountain States Tumor Institute

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

Facility Name

Mountain States Tumor Institute

City

Fruitland

State/Province

Idaho

ZIP/Postal Code

83619

Country

United States

Facility Name

Mountain States Tumor Institute

City

Meridian

State/Province

Idaho

ZIP/Postal Code

83642

Country

United States

Facility Name

Mountain States Tumor Institute

City

Nampa

State/Province

Idaho

ZIP/Postal Code

83686

Country

United States

Facility Name

Mountain States Tumor Institute

City

Twin Falls

State/Province

Idaho

ZIP/Postal Code

83301

Country

United States

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital

City

New Lenox

State/Province

Illinois

ZIP/Postal Code

60451

Country

United States

Facility Name

University of Chicago Medical Center for Advanced Care Orland Park

City

Orland Park

State/Province

Illinois

ZIP/Postal Code

60462

Country

United States

Facility Name

Indiana University - Wishard Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Indiana University Health - Melvin and Bren Simon Cancer Center

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Indiana University Health - University Hospital

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Indiana University - Springmill Medical Clinic

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

Facility Name

Eastern Maine Medical Center's Cancer Care

City

Brewer

State/Province

Maine

ZIP/Postal Code

04412

Country

United States

Facility Name

Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Suburban Hospital Cancer Program

City

Bethesda

State/Province

Maryland

ZIP/Postal Code

20817

Country

United States

Facility Name

Johns Hopkins - Green Spring Station

City

Lutherville

State/Province

Maryland

ZIP/Postal Code

21093

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Dana Farber Cancer Institute at Faulkner Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02130

Country

United States

Facility Name

Beth Israel Deaconess Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Dana-Farber Cancer Institute

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Mass General North Shore Cancer Center

City

Danvers

State/Province

Massachusetts

ZIP/Postal Code

01923

Country

United States

Facility Name

Lowell General Hospital

City

Lowell

State/Province

Massachusetts

ZIP/Postal Code

01854

Country

United States

Facility Name

Dana-Farber Cancer Institute at Milford Hospital

City

Milford

State/Province

Massachusetts

ZIP/Postal Code

01757

Country

United States

Facility Name

Univeristy of Michigan Health System

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Barnes-Jewish Hospital

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Washington University, School of Medicine

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Facility Name

Siteman Cancer Center - South County

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63129

Country

United States

Facility Name

Siteman Cancer Center - West County

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Siteman Cancer Center - St. Peters

City

Saint Peters

State/Province

Missouri

ZIP/Postal Code

63376

Country

United States

Facility Name

New Hampshire Oncology-Hematology, PA

City

Concord

State/Province

New Hampshire

ZIP/Postal Code

03301

Country

United States

Facility Name

New Hampshire Oncology-Hematology, PA

City

Hooksett

State/Province

New Hampshire

ZIP/Postal Code

03106

Country

United States

Facility Name

New Hampshire Oncology-Hematology, PA

City

Laconia

State/Province

New Hampshire

ZIP/Postal Code

03246

Country

United States

Facility Name

Dana-Farber Cancer Insitute at Londonderry Hospital

City

Londonderry

State/Province

New Hampshire

ZIP/Postal Code

03053

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center-Basking Ridge

City

Basking Ridge

State/Province

New Jersey

ZIP/Postal Code

07920

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center-Suffolk

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center Westchester

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Facility Name

Queens Hospital Center, Comprehensive Cancer Center

City

Jamaica

State/Province

New York

ZIP/Postal Code

11432

Country

United States

Facility Name

Northwell Health/Monter Cancer Center

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center-Mercy

City

Rockville Centre

State/Province

New York

ZIP/Postal Code

11570

Country

United States

Facility Name

Memorial Sloan Kettering Cancer Center-Sleepy Hollow

City

Sleepy Hollow

State/Province

New York

ZIP/Postal Code

10591

Country

United States

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Duke University Medical Center

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27710

Country

United States

Facility Name

Rex Cancer Center

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

The Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Facility Name

Lehigh Valley Hospital/Lehigh Valley Health Network

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18103

Country

United States

Facility Name

UPMC/HVHS Cancer Center, UPMC Beaver

City

Beaver

State/Province

Pennsylvania

ZIP/Postal Code

15143

Country

United States

Facility Name

UPMC CancerCenters Butler

City

Butler

State/Province

Pennsylvania

ZIP/Postal Code

16001

Country

United States

Facility Name

UPMC Horizon (Shenango)

City

Farrell

State/Province

Pennsylvania

ZIP/Postal Code

16121

Country

United States

Facility Name

Arnold Palmer Cancer Center-Greensburg

City

Greensburg

State/Province

Pennsylvania

ZIP/Postal Code

15601

Country

United States

Facility Name

Arnold Palmer Medical Oncology Oakbrook

City

Greensburg

State/Province

Pennsylvania

ZIP/Postal Code

15642

Country

United States

Facility Name

UPMC Horizon (Greenville)

City

Greenville

State/Province

Pennsylvania

ZIP/Postal Code

16125

Country

United States

Facility Name

UPMC Pinnacle Harrisburg

City

Harrisburg

State/Province

Pennsylvania

ZIP/Postal Code

17101

Country

United States

Facility Name

UPMC Cancer Center Jefferson Regional Med Ctr

City

Jefferson Hills

State/Province

Pennsylvania

ZIP/Postal Code

15025

Country

United States

Facility Name

UPMC Conemaugh Cancer Center

City

Johnstown

State/Province

Pennsylvania

ZIP/Postal Code

15905

Country

United States

Facility Name

UPMC McKeesport

City

McKeesport

State/Province

Pennsylvania

ZIP/Postal Code

15132

Country

United States

Facility Name

UPMC East

City

Monroeville

State/Province

Pennsylvania

ZIP/Postal Code

15146

Country

United States

Facility Name

Arnold Palmer Medical Oncology-Mt Pleasant

City

Mount Pleasant

State/Province

Pennsylvania

ZIP/Postal Code

15666

Country

United States

Facility Name

UPMC Jameson Cancer Center

City

New Castle

State/Province

Pennsylvania

ZIP/Postal Code

16105

Country

United States

Facility Name

UPMC St. Margaret

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15215

Country

United States

Facility Name

UPMC Cancer Center St. Clair Hospital

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

UPMC Presbyterian Shadyside

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15232

Country

United States

Facility Name

UPMC Passavant

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15237

Country

United States

Facility Name

UPMC Northwest (Franklin)

City

Seneca

State/Province

Pennsylvania

ZIP/Postal Code

16346

Country

United States

Facility Name

UPMC Northwest (Oil City)

City

Seneca

State/Province

Pennsylvania

ZIP/Postal Code

16346

Country

United States

Facility Name

UPMC and the Washington Hospital Center

City

Washington

State/Province

Pennsylvania

ZIP/Postal Code

15301

Country

United States

Facility Name

Tennessee Oncology/Sarah Cannon Research Institute

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Baylor College of Medicine-Baylor Clinic

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Harris County Hospital District-Ben Taub General Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Harris County Hospital District-Smith Clinic

City

Houston

State/Province

Texas

ZIP/Postal Code

77054

Country

United States

Facility Name

University of Washington Seattle Cancer Care Alliance

City

Seattle

State/Province

Washington

ZIP/Postal Code

98109

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

35173164

Citation

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.

Results Reference

derived

PubMed Identifier

34077270

Citation

Tolaney SM, 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 K, Zheng Y, Rosenberg SM, Gelber RD, Trippa L, Barry W, DeMeo M, Burstein H, Partridge A, Winer EP, Krop I. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. J Clin Oncol. 2021 Jul 20;39(21):2375-2385. doi: 10.1200/JCO.20.03398. Epub 2021 Jun 2.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs