Study Details

Open

T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-positive breast cancer

Purpose: Is the combination of T-DM1 and a newer drug tucatinib, better than usual treatment with T-DM1 alone at preventing your cancer from returning? Treatment with T-DM1 and placebo or T-DM1 and tucatinib, for up to 14 cycles, unless the breast cancer returns or the side effects become too severe. If the breast cancer returns while on the study, the treatment will be changed. After completion of T-DM1 and/or placebo, or T-DM1 and tucatinib, the study doctor will continue to follow the patients condition with clinic visits every 6 months for 10 years and watch for side effects and for signs of breast cancer returning.

Age & Gender

18 years ~ 99 years
Male, Female

Location

United States (Nationwide)

What will be asked of you

If you decide to take part in this study, you will either get treatment with T-DM1 and placebo (a pill that looks like the study drug but contains no medication) or T-DM1 and tucatinib, for up to 14 cycles, unless your breast cancer returns or the side effects become too severe. ? The study involves blood draws, pregnancy testing (if female), physical exams, receipt of study drugs, questionnaires, pill diaries, Echo or MUGA scans. You will meet with a member of the study team in addition to your oncology care team during your visits.After you finish T-DM1 and placebo, or T-DM1 and tucatinib, your doctor will continue to follow your condition with clinic visits every 6 months for 10 years and watch you for side effects and for signs of breast cancer returning. This means you will keep seeing your doctor for 10 years after you are enrolled in the study.

Total length of participation:
If you decide to take part in this study, you will either get treatment with T-DM1 and placebo (a pill that looks like the

Looking for Healthy Volunteers

Requirements for healthy volunteers are different than for those with a specific condition. If you are interested in becoming a healthy volunteer for this study, use the below categories to determine if you are able to participate.

Able to participate:

You have been diagnosed with HER2-positive breast cancer
You received surgery for your HER2 positive breast cancer and there was cancer still present in the tissue removed at surgery.
You received chemotherapy prior to your surgery for your HER2 positive breast cancer.

Not eligible if:

You have been diagnosed with metastatic breast cancer
You have received treatment for your breast cancer after your surgery within 28 days of starting the study.
You are pregnant or breastfeeding a child.
Your breast cancer has returned following pre-operative chemotherapy and surgery.
You have had a major surgery unrelated to your breast cancer within 28 days of starting the study.

Contact the Team

Visit Location

Contact & Visit Location

Additional Study Information

Principal Investigator

Lisa Carey
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Breast)
Sexual and/or Reproductive Health
Women's Health

IRB Number

21-0233

ClinicalTrials.gov

NCT04457596