Active — Not RecruitingPhase 2

ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer

United States111 participantsStarted 2018-08-22

Plain-language summary

This research study is studying an investigational drug as a possible treatment for breast cancer that is positive for the protein Human Epidermal Growth Factor Receptor 2, also known as HER2-positive breast cancer. The drug involved in this study is: -ado-trastuzumab emtansine (T-DM1)

Who can participate

Age range60 Years

SexALL

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Inclusion criteria

✓≤90 days from the patient's most recent breast surgery for this breast cancer. Note: In cases where registration will occur \>90 days from surgery but within an acceptable time frame, patient may be eligible for enrollment with approval from the PI, Rachel Freedman MD, MPH.

Exclusion criteria

✕\>90 days of tamoxifen therapy, or other hormonal therapy, for adjuvant therapy for this malignancy

What they're measuring

Invasive Disease-free Survival Rate (IDFS)

Timeframe: 5 years

Trial details

NCT IDNCT03587740

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-03

Results submitted2026-02-20

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