Clinical Trials

Study Title

Phase 3 neoadjuvant study of T-DXd or T-DXd followed by THP versus ddAC-THP in participants with early-stage high-risk HER2+ breast cancer (Destiny)

Purpose

To demonstrate superiority of neoadjuvant T-DXd alone or in sequence with THP relative to ddAC-THP by assessment of pCR (ypT0/Tis ypN0) using central evaluation in participants with HER2-positive EBC

Eligibility

1. Histologically documented HER2-positive breast cancer. 2. Adequate organ and bone marrow function

3. Negative pregnancy test for women of childbearing potential 4. Female participants must be 1 year post-menopausal, surgically sterile, or using one highly effective form of non-hormonal birth control.

5. Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception.

You Cannot

1.Have prior history of invasive breast cancer.

2.Have stage IV breast cancer.

3.Have uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.

4. Have active hepatitis C infection.

5. Have active primary immunodeficiency or known to have tested positive for HIV or active tuberculosis infection.

6. Have a medical history of myocardial infarction within 6 months before enrolment, symptomatic congestive heart failure, unstable angina pectoris, or a recent (< 6 months) cardiovascular event including stroke.

7. Have history of (non-infectious) Interstitial Lung Disease/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.

8. Receipt of live, attenuated vaccine within 30 days prior to the first dose study intervention.

Study Process

1. Chemotherapy will be given every two weeks or every three weeks depending on medication assigned. 

2. Lab drawn during regularly scheduled visits.

3. Scans every 6 weeks.