RecruitingPhase 3

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer

A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe trastuzumab deruxtecan (T-DXd) is and how well it works for breast cancer that cannot be removed by surgery or has spread. It is for people whose cancer has low or no HER2 on testing, whether or not it has hormone receptors.

This study will evaluate the safety and efficacy of trastuzumab deruxtecan (T-DXd) in participants with human epidermal growth factor receptor 2 (HER2)-low or HER2 immunohistochemistry (IHC) 0 (who are both hormone receptor \[HR\]-negative and HR-positive) unresectable and/or metastatic breast cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form and agree to provide a new or stored tumor tissue sample.
  • Have breast cancer confirmed by tissue testing that cannot be removed by surgery or has spread. It must test HER2-low or HER2 IHC 0, never have tested HER2-positive, and never have been treated with HER2-targeted drugs after spreading.
  • Have had 1 or 2 rounds of treatment plans for cancer that has spread. People in the hormone receptor-positive, HER2-low group must also meet specific rules about how soon cancer returned or worsened after hormone treatment or drugs called CDK4/6 inhibitors.
  • Have at least one tumor that can be measured on a CT or MRI scan. Any brain tumors must be smaller than 2 cm, untreated, stable, cause no symptoms, and need no urgent care.
  • Be fully active or able to do light work despite limits on hard physical activity. Be expected to live at least 12 weeks.
  • Have a heart pumping level of at least 50% and good enough organ and bone marrow function, tested within 28 days before joining.
  • Have enough time between your last treatment and joining the study.
  • Agree to use highly effective birth control if you or your partner could become pregnant.

Who can't join

  • Have had an antibody-drug conjugate, a treatment that links an antibody to a cancer-killing drug.
  • Have serious or uncontrolled heart disease, or a heart rhythm test showing a prolonged QT interval.
  • Have current or suspected lung inflammation called ILD or pneumonitis, or a past case not caused by infection that needed steroids. Other serious lung illnesses or past removal of an entire lung also rule you out.
  • Have pressure on the spinal cord or active cancer spread in the brain or spinal cord.
  • Have had more than one primary cancer within 3 years, with exceptions for certain fully treated cancers or cancer in the other breast.
  • Have had severe allergic reactions to the study drug's ingredients or other antibody medicines, or have more than mild lasting side effects from past cancer treatment, except hair loss.
  • Have an uncontrolled infection needing medicine through a vein; an active inherited immune system weakness; known uncontrolled active HIV; active hepatitis B or C; or an autoimmune, connective tissue, or inflammatory disorder.
  • Have received a live weakened vaccine within 30 days before the first study dose, or are pregnant, breastfeeding, or planning to become pregnant.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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.

Study sites (5)

FL

MA

NJ