A Phase III Study of Presurgical Trastuzumab Deruxtecan Alone or followed by THP Compared to Standard Treatment for High-Risk HER2-Positive Early-Stage Breast Cancer

Share

Full Title

A Phase 3 Open-label Trial of Neoadjuvant Trastuzumab Deruxtecan (T-DXd) Monotherapy or T-DXd followed by THP Compared to ddAC-THP in Participants with High-risk HER2-positive Early-stage Breast Cancer (DESTINY-Breast11) (WCG IRB)

Purpose

The purpose of this study is to assess the safety and effectiveness of trastuzumab deruxtecan (T-DXd) alone or in a sequence with paclitaxel, trastuzumab, and pertuzumab (THP) compared with standard treatment using dose-dense doxorubicin and cyclophosphamide followed by THP (ddAC-THP) when given as initial therapy in people with high-risk HER2-positive early-stage breast cancer.

T-DXd is an “antibody drug conjugate” (ADC). ADCs have two parts: the antibody targets cancer cells and the other part (a chemotherapy drug attached to the antibody) kills cancer cells. Trastuzumab, the antibody part, binds to HER2 on cancer cells. When trastuzumab sticks to HER2, deruxtecan (the cell-killing chemotherapy part) is released and kills the cancer cell from within.

Trastuzumab, pertuzumab, and paclitaxel are each often used in combination with other medications to block cancer cell growth and treat HER2-positive early breast cancer. All participants in this study will be randomly assigned to receive either T-DXd alone, T-DXd followed by THP, or standard treatment with ddAC-THP. The medications used in this study are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have stage I-III breast cancer that is positive for the HER2 protein and has a high risk of recurrence. They will need to provide at least 22 unstained slides from the breast cancer biopsy or undergo a new biopsy to confirm the HER2 status of the cancer. 
  • Prior treatment for breast cancer is not permitted.
  • Patients must have normal heart function and no significant lung problems or history of pneumonitis (lung inflammation).
  • Patients must have a clear body scan (preferably a PET scan) and a clear high-resolution CT scan of the chest in order to participate.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
  • This study is for people age 18 and older.

Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Shanu Modi at 646-888-4564.

Protocol

22-120

Phase

Phase III (phase 3)

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT05113251