T-DM1 for Breast Cancer

Palo Alto (17 mi)

Overseen byRachel Freedman, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Approved in 5 jurisdictions

Trial Summary

What is the purpose of this trial?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)

Eligibility Criteria

This trial is for individuals aged 60 or older with HER2-positive Stage I-III breast cancer who haven't had metastatic disease, prior invasive breast cancer within 5 years, or certain treatments like neoadjuvant chemotherapy. They must have an ECOG Performance Status of 0-2 and be willing to use birth control and provide blood samples.

Inclusion Criteria

I am 60 years old or older.

I can take care of myself and perform daily activities.

I have taken a pregnancy test in the last week and it was negative.

My cancer is HER2 positive, confirmed by tests and a specialist review.

My breast cancer is confirmed and falls within Stage I-III, meeting specific size and node criteria.

My tumor was completely removed by surgery.

Exclusion Criteria

I have been treated with a certain amount of anthracycline drugs.

My cancer has spread to other parts of my body.

My cancer is advanced but hasn't spread far, and my other breast has HER2-negative cancer.

I do not have severe liver, heart, lung diseases, or other serious illnesses.

I am not on any experimental drugs for my cancer.

I have received initial chemotherapy for my breast cancer.

I have previously received T-DM1 or trastuzumab therapy.

I had breast cancer less than 5 years ago.

I have another cancer or had one with a high risk of coming back.

Treatment Details

The ATOP TRIAL is evaluating the investigational drug ado-trastuzumab emtansine (T-DM1) as a potential treatment for patients with HER2-positive breast cancer who either declined standard therapy or are not candidates for it.

1Treatment groups

Experimental Treatment

Group I: T-DM1Experimental Treatment1 Intervention

T-DM1 will be administered every 3 weeks intravenously, with 21 consecutive days defined as a treatment.

T-DM1 is already approved in European Union, United States, Canada, Japan, China for the following indications:

🇪🇺 Approved in European Union as Kadcyla for: