T-DM1 for Breast Cancer

Recruiting at87 trial locations

Overseen by Sara Tolaney, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

Stay on Your Current Meds

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sara Tolaney, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for individuals with HER2-positive Stage I breast cancer, who have had recent surgery and may have started hormonal therapy. They must not be pregnant or breastfeeding, free from certain other cancers for 5 years, without active infections or liver disease, and agree to use effective contraception.

Inclusion Criteria

All margins should be clear of invasive cancer or DCIS

Must have discontinued any investigational drug at least 2 weeks prior to participation

I have had my ovaries removed to prevent cancer.

Exclusion Criteria

Excessive alcohol intake (more than 3 alcoholic beverages per day)

I have had chemotherapy within the last 5 years.

I have an active liver condition.

Treatment Details

Interventions

• Paclitaxel (Taxane)
• Trastuzumab (Monoclonal Antibodies)
• Trastuzumab emtansine (Monoclonal Antibodies)

Trial Overview The ATEMPT trial is testing the effectiveness of T-DM1 (an investigational drug) against the standard treatment combination of paclitaxel and trastuzumab in preventing breast cancer recurrence. It's a Phase II study comparing side effects and long-term benefits.

Participant Groups

Group I: Paclitaxel + Trastuzumab Active Control 2 Interventions

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

Group II: Trastuzumab emtansine (T-DM1) Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management