T-DXd for HER2 Positive Breast Cancer
(DESTINY-B12 Trial)

Recruiting in Palo Alto (17 mi)

+79 other locations

Overseen byNadia Harbeck, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: AstraZeneca

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a new cancer drug called Trastuzumab deruxtecan in patients with advanced HER2-positive breast cancer that has not responded to other treatments. The drug targets cancer cells with a specific marker and delivers a powerful drug to kill them. The study includes patients with and without brain metastasis to see how well the drug works and how safe it is. Trastuzumab deruxtecan is a new type of treatment that has shown impressive results in patients who have already received many other treatments.

Eligibility Criteria

This trial is for people with advanced or metastatic HER2 positive breast cancer who have had disease progression after prior anti-HER2 therapies and no more than two treatments in the metastatic setting. It includes those with or without brain metastasis (BMs), provided BMs are stable, untreated but not needing immediate therapy, or previously treated. Participants must be physically capable (ECOG 0-1), have a heart ejection fraction ≥50%, and women of childbearing potential must test negative for pregnancy.

Inclusion Criteria

You have had breast cancer treatment that did not work, and you have tried no more than 2 different treatments for cancer that has spread.

You cannot have signs of brain metastases, or if you do, they must not need immediate treatment or must have been treated and are not getting worse.

You have at least one lesion that can be measured accurately and is at least 10 mm in diameter, or you have non-measurable bone disease that can be assessed by imaging. If you have only sclerotic/osteoblastic bone lesions without measurable disease, you are not eligible. If you have non-measurable central nervous system (CNS) disease, you may be eligible for a specific part of the study.

See 7 more

Exclusion Criteria

If you have hepatitis C, you can join the study only if a specific test shows that the virus is not active in your body.

You had a heart attack or have significant heart failure symptoms within the past 6 months.

You should not have untreated brain lesions larger than 2.0 cm, be using systemic corticosteroids for brain lesion symptoms, or have uncontrolled seizures or worsening neurological symptoms due to brain lesions.

See 16 more

Treatment Details

Interventions

Trastuzumab Deruxtecan (Antibody-Drug Conjugate)

Trial OverviewThe study tests Trastuzumab Deruxtecan (T-DXd) on participants to evaluate its effectiveness and safety. The trial is open-label, meaning everyone knows which treatment they're getting, and it's conducted at multiple centers internationally. Patients included may have measurable lesions suitable for repeated assessments or non-measurable bone-only diseases assessable by scans.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Trastuzumab DeruxtecanExperimental Treatment1 Intervention

Participants with or without BM at baseline will receive intravenous (IV) T-DXd, 5.4 mg/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.

Trastuzumab Deruxtecan is already approved in European Union, United States, Japan for the following indications:

🇪🇺 Approved in European Union as Enhertu for:

Unresectable or metastatic HER2-positive breast cancer
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma

🇺🇸 Approved in United States as Enhertu for:

Unresectable or metastatic HER2-positive breast cancer
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma
HER2-low breast cancer

🇯🇵 Approved in Japan as Enhertu for:

Unresectable or metastatic HER2-positive breast cancer
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma