Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Hope Rugo, MD
Headshot of Hope Rugo
Hope Rugo

Description

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

Official Title

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)

Details

Keywords

Breast Cancer, HER2-positive Breast Cancer, Breast Neoplasms, Paclitaxel, Maytansine, Ado-Trastuzumab Emtansine, Trastuzumab, trastuzumab-emtansine, Trastuzumab SC

Eligibility

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States

Lead Scientist at UCSF

  • Hope Rugo, MD
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dana-Farber Cancer Institute
ID
NCT04893109
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated