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RecruitingLast updated: 24 May 2023

DESTINY-B12: This Phase III trial is evaluating how safe and effective targeted therapy (Trastuzumab deruxtecan (T-DXd)) is in patients with advanced or metastatic HER2-positive breast cancer that has or has not spread to the brain.An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12)

Clinical summary

Summary

This is a non-randomised trial with two cohorts that both receive the same treatment. Patients will be enrolled into cohorts according to the presence or absence of brain metastases at baseline. Cohort 1 will include participants without BM at baseline and Cohort 2 will consist of participants with BM at baseline. All participants will receive Trastuzumab Deruxtecan (T-DXd) intravenously, 5.4mg/kg, every 3 weeks (21-day cycle) until Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) defined radiological progression outside central nervous system, unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.

Conditions

This trial is treating patients with HER2-positive breast cancer.

Cancer

Breast Cancers Breast

Age

People18 - 130

Phase

III

Trial Acronym

DESTINY-B12

More information

Trial Identifiers

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Commercial Sponsor

AstraZeneca

Scientific Title

An Open-Label, Multinational, Multicenter, Phase 3b/4 Study of Trastuzumab Deruxtecan in Patients With or Without Baseline Brain Metastasis With Previously Treated Advanced/Metastatic HER2-Positive Breast Cancer (DESTINY-Breast12)

Eligibility

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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