Welcome to the DESTINY BREAST-12 Study Site Portal

What is DESTINY BREAST-12?

DESTINY BREAST-12 is a Phase IIIb/IV study seeking to better understand the treatment benefit of trastuzumab deruxtecan (T-DXd) in adult patients with or without brain metastases who have unresectable/advanced or metastatic HER2-positive breast cancer.

Key objectives of DESTINY BREAST-12 are to determine:

• the overall treatment effect of T-DXd in HER2-positive metastatic breast cancer (mBC) patients with or without baseline brain metastases (BM).
• the treatment effect on the development and progression of BM in patients with or without baseline BM using additional efficacy measurements.
• T-DXd’s efficacy in patients with stable or untreated BM.
• the effect of T-DXd on symptoms, functioning and HRQoL in HER2-postive mBC patients with or without baseline BM.
• the safety profile of T-DXd.

What is being investigated?

T-DXd is an antibody-drug conjugate that targets HER2; it is currently approved in the US, Europe and Japan. Participants will receive intravenous T-DXd 5.4 mg/kg every 3 weeks (21-day cycle) for as long as they continue to show clinical benefit (determined by the study investigator).

Eligible participants must:

• be ≥ 18 years of age*.
• have a diagnosis of unresectable/advanced or metastatic breast cancer and a confirmed HER2-positive expression.
• have radiologic or objective evidence of disease progression on trastuzumab, pertuzumab, or T-DM1 (≤ 2 lines/regimens of therapy in the metastatic setting).

_{*For participants aged < 20 years and enrolled in Japan, a written informed consent should be obtained from the participant and his or her legally acceptable representative.}