DESTINY Breast Respond HER2-low Europe

Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study ID
NCT05945732
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    This is a non-interventional study and medication will be administered according to the SmPC as local standard of care and as part of the routine clinical practice. Trastuzumab (T-DXd) to be administered according to the SmPC. Conventional therapy (eg. capecitabine, eribulin, gemcitabine, paclitaxel, nab paclitaxel) to be administered according to the SmPC.

Study Details

Trastuzumab deruxtecan (T-DXd) as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Key Dates

Start date
Oct 24, 2023
Status verified
Feb 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2028

Study Design

Enrollment
1,155 participants (estimated)

Arms

  • Arm: Trastuzumab deruxtecan (T-DXd)
    Participants with HER2-low expressing unresectable and/or metastatic breast cancer who will be treated with trastuzumab deruxtecan and part of the enrolled participants will receive conventional chemotherapy. The participants on conventional chemotherapy will be analyzed exploratory only.

Primary Outcome Measure

Real World Time to Next Treatment (rwTTNT1) in Participants With HER2-low Expressing Unresectable and/or Metastatic Breast Cancer [ Time Frame: Baseline up to 31 months ]

Central Contacts

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