Trastuzumab Deruxtecan for Metastatic Breast Cancer
This study is testing Trastuzumab Deruxtecan (T-DXd) for people with unresectable (cannot be removed by surgery) or metastatic (spread to other parts of the body) breast cancer. This includes those with HER2-low or HER2 IHC 0 breast cancer, regardless of whether it's hormone receptor-negative or hormone receptor-positive. The main goal is to see how long patients can benefit from Trastuzumab Deruxtecan before needing another cancer treatment. To join, you must have breast cancer that is unresectable or metastatic, and provide a recent or archived biopsy. The study plans to enroll 250 participants, but its current recruitment status is unclear.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 250 participants.
- What's involved
- Participants will receive Trastuzumab Deruxtecan intravenously every 21 days until their disease progresses, they experience unacceptable side effects, or for up to 2 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed to assess the time until subsequent therapy or death, for up to 24 months.
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NCT05950945
Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer
Recruiting
PHASE3Ages 18+InterventionalTreatmentDaiichi Sankyo
~250 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Trastuzumab Deruxtecan
At a glance
Recruiting sites
68 of 88 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT)
Measured over Until subsequent therapy or death, assessed up to 24 months
Conditions
Where it's being run
88 sites across 14 statesBrazil15
China14
Spain14
Italy11
Netherlands8
Belgium7
Ireland5
Portugal5
Study leadership
- Global Clinical Leader · STUDY_DIRECTOR · Daiichi Sankyo
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Sign and date the main informed consent form
Must agree to provide a newly obtained or archival baseline biopsy from primary and/or metastatic lesion.
Pathologically documented Breast Cancer (BC) tumor
Is unresectable and/or metastatic.
Is hormone receptor-negative or hormone receptor-positive.
Must include percentage of positively stained cells to characterize if hormone receptor-positive or -negative.
Has confirmed HER2 IHC 1+ or IHC 2+/ISH- (HER2-low) status or HER2 IHC 0 status as determined according to ASCO CAP 2018 guidelines1 based on sample collected during Tissue Screening as described above.
Was never previously HER2-positive (IHC 3+ or IHC 2+/ISH+) on prior pathology testing (per ASCO CAP guidelines).
Was never previously treated with anti-HER2 therapy in the metastatic setting.
Has had at least one and up to two prior lines of therapy in the metastatic setting.
In participants with hormone receptor-positive HER2-low metastatic BC (Cohort 3):
Has recurrent disease \<2 years from the initiation of adjuvant ET OR
Has disease progression on CDK4/6 inhibitor-based regimen within 12 months of completion of adjuvant therapy with a CDK4/6 inhibitor OR
Has disease progression within the first 12 months of CDK4/6 in the first line metastatic setting
Presence of at least one measurable lesion based on computed tomography or magnetic resonance imaging.
Participants with brain metastases are allowed in the study. The brain lesion(s) should be small (\<2 cm), untreated, asymptomatic, not requiring urgent medical intervention, and are asymptomatic and clinically stable.
Has an Eastern Cooperative Oncology Group performance status of 0 or 1.
Has a minimum life expectancy of 12 weeks at Screening.
Has a left ventricular ejection fraction ≥50% within 28 days before enrollment.
Has adequate organ and bone marrow function within 28 days before enrollment.
Has adequate treatment washout period before enrollment.
Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception.
Exclusion
Prior treatment with an antibody drug conjugate (ADC).
Uncontrolled or significant cardiovascular disease.
Has a corrected QT interval prolongation.
Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Has spinal cord compression or clinically active central nervous system metastases.
Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, other solid tumors curatively treated, or contralateral BC.
Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
Active primary immunodeficiency, known uncontrolled active human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection.
Has history of receiving a live, attenuated vaccine (messenger RNA and replication-deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study drug.
Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline.
Is pregnant or breastfeeding or planning to become pregnant.
Lung-specific intercurrent clinically significant illnesses.
Any autoimmune, connective tissue, or inflammatory disorders.
Prior complete pneumonectomy.
What this trial measures
- Time From the Start of T-DXd to Initiation of Subsequent Anticancer Treatment (TTNT)Until subsequent therapy or death, assessed up to 24 months
TTNT is defined as the time interval from the date of first dose of T-DXd to the initiation of the next anticancer treatment or death due to any cause.