RecruitingPhase 2NCT04893109

ATEMPT 2.0: Adjuvant T-DM1 vs TH

A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0)

Sponsor

Dana-Farber Cancer Institute

Enrollment

500 participants

Start Date

Jun 16, 2021

Study Type

INTERVENTIONAL

Conditions

Breast Cancer HER2-positive Breast Cancer

Summary

This research study is studying how well newly diagnosed breast cancer that has tested positive for a protein called HER2 responds using one of two different combination of HER2-directed therapies as a treatment after surgery. The name of the study drugs involved are: * Trastuzumab-emtansine (T-DM1, Kadcyla) * Trastuzumab SC (Herceptin Hylecta) * Paclitaxel

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is comparing two adjuvant (post-surgery) treatments for patients with early-stage, HER2-positive breast cancer: T-DM1 (a targeted antibody-drug combination) versus trastuzumab plus paclitaxel (the current standard). The goal is to see which approach is more effective with fewer side effects. **You may be eligible if...** - You are 18 or older and have had surgery to remove a stage I, HER2-positive breast cancer - Your cancer is node-negative or has only tiny deposits in lymph nodes (micrometastases) - Your HER2 status has been centrally confirmed as positive - You have undergone a lumpectomy or mastectomy with clear margins - You had surgery within the past 90 days - You have adequate blood counts and heart function (ejection fraction ≥50%) **You may NOT be eligible if...** - You have a history of previous invasive breast cancer - You have received prior chemotherapy in the past 5 years (especially paclitaxel) - You have active liver disease (hepatitis B, C, autoimmune liver disease) - You are pregnant or breastfeeding - You have had prior radiation to the whole breast - You have another active serious medical condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGtrastuzumab-emtansine

intravenous infusion

DRUGTrastuzumab SC

Muscular injection

DRUGPaclitaxel

intravenous infusion

Locations(53)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, United States

Smilow Cancer Hospital Care center at Derby

Derby, Connecticut, United States

Smilow Cancer Hospital Care center at Fairfield

Fairfield, Connecticut, United States

Smilow Cancer Hospital Care center at Glastonbury

Glastonbury, Connecticut, United States

Smilow Cancer Hospital Care center at Greenwich

Greenwich, Connecticut, United States

Smilow Cancer Hospital Care center at Guilford

Guilford, Connecticut, United States

Smilow Cancer Hospital Care center at St. Francis

Hartford, Connecticut, United States

Smilow Cancer Hospital Care center at Long Ridge

Long Ridge, Connecticut, United States

Yale Cancer Center at Yale University School of Medicine

New Haven, Connecticut, United States

Smilow Cancer Hospital Care center at North Haven

North Haven, Connecticut, United States

Stamford Hospital

Stamford, Connecticut, United States

Smilow Cancer Hospital Care center at Torrington

Torrington, Connecticut, United States

Smilow Cancer Hospital Care center at Trumbull

Trumbull, Connecticut, United States

Smilow Cancer Hospital Care center at Waterbury

Waterbury, Connecticut, United States

Smilow Cancer Hospital Care center at Waterford

Waterford, Connecticut, United States

Miami Cancer Institute/Baptist Hospital of Miami

Miami, Florida, United States

Miami Cancer Institute - Plantation (MCIP)

Plantation, Florida, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

Indiana University Health Joe & Shelly Schwarz Cancer Center

Carmel, Indiana, United States

IU Health North Hospital

Carmel, Indiana, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Indiana University Sidney and Lois Eskenazi Hospital

Indianapolis, Indiana, United States

Eastern Maine Medical Center (Northern Light)

Brewer, Maine, United States

New England Cancer Specialists

Scarborough, Maine, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Dana-Farber at St. Elizabeth's Medical Center

Brighton, Massachusetts, United States

Lahey Clinic

Burlington, Massachusetts, United States

Mass General North Shore Cancer Center

Danvers, Massachusetts, United States

Dana-Farber Brigham Cancer Center - Foxborough

Foxborough, Massachusetts, United States

Dana-Farber Cancer Instiute - Merrimack Valley

Methuen, Massachusetts, United States

Dana-Farber at Milford

Milford, Massachusetts, United States

Newton Wellesley Hospital

Newton, Massachusetts, United States

Berkshire Medical Center

Pittsfield, Massachusetts, United States

Dana Farber at South Shore Hospital

Weymouth, Massachusetts, United States

NH Oncology-Hematology, PA - Payson Center for Cancer Care

Concord, New Hampshire, United States

Dana-Farber Cancer Insitute at Londonderry Hospital

Londonderry, New Hampshire, United States

Solinsky Center for Cancer Care (NH Oncology-Hematology, PA)

Manchester, New Hampshire, United States

New England Cancer Specialists - Portsmouth

Portsmouth, New Hampshire, United States

New York University Langone Hospital -Brooklyn

Brooklyn, New York, United States

New York University Langone Hospital - Long Island

Mineola, New York, United States

New York University Langone Health

New York, New York, United States

Northwell University

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Duke Women's Cancer Care Raleigh

Raleigh, North Carolina, United States

Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, United States

University of Pennsylvania, Abramson Cancer Center

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center Cancer UPMC- Magee Women's Hospital

Pittsburgh, Pennsylvania, United States

Smilow Cancer Hospital Care center at Westerly

Westerly, Rhode Island, United States

Greco-Hainsworth Centers for Research/Tennessee Oncology

Nashville, Tennessee, United States

SCRI Oncology Partners

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04893109

Related Trials

Genomic Services Research Program

NCT025959571 location

Safety and Tolerability of ²¹²Pb-DOTAM-GRPR1 in Adult Subjects With Recurrent or Metastatic GRPR-expressing Tumors

NCT052833304 locations

A Synthetic Lethality-Focused Algorithm to Identify Therapeutic Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

NCT070671381 location

Social and Environmental Determinants of Breast Cancer Survivorship: the Black Breast Cancer Survivor's Intervention (BBCSI)

NCT068852031 location

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer

NCT06103864316 locations