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Compares treatment options for Hormone Receptor(HR)-Positive, Low HER2 Advanced Breast Cancer...
Official title Trastuzumab Deruxtecan vs Endocrine Therapy in Low-HER2 HR+ Advanced Breast Cancer
ClinicalTrials.gov ID: NCT06837792
What this study is testing
What is Experimental treatment arm?
Experimental treatment arm is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hormone receptor(hr)-positive, low her2 advanced breast cancer patients (her2 ihc 1+ or 2+ & ish negative).
Also referred to as T-DXd arm.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- "This is a randomized phase II, two-arm, open label, clinical trial to identify LP-WGS ctDNA biomarker to predict T-DXd response in low-HER2 expressing advanced breast cancer patients compared with endocrine therapy. The hormone receptor (HR)-positive low-HER2 advanced breast cancer patients (HER2 IHC 1+ or 2+ \& ISH negative, n=141) who progressed on 1st line endocrine + CDK4/6 inhibitor therapy and received no other systemic therapy for advanced disease are enrolled in this study.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 and older, women only
You may be able to join if
- Histologically or cytologically confirmed hormone receptor-positive advanced breast cancer patients
- Have recurrent, metastatic, or unresectable disease
- Have HER2-low expression status, defined as IHC 2+/ISH- or IHC 1+,with a validated assay by ASCO/CAP guidelines
- Have no previous history of HER2-positive breast cancer (IHC 3+ or ISH+) by ASCO/CAP guidelines
- The hormone receptor (HR) status is defined by ER/PR IHC nuclear staining, and ER or PgR ≥1% is defined as hormone receptor-positive status
You likely can't join if
- Previous history of T-DXd or Dato-Dxd treatment for advanced breast cancer
- Severe Cardiac disease (e.g., uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease...
- Patients with a medical history of myocardial infarction (MI) within 6 months before randomization/enrolment, symptomatic congestive heart failure...
- Current active hepatic or biliary disease (except for Gilbert syndrome, asymptomatic gallstones, liver metastasis or stable chronic liver disease per...
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days...
See the full eligibility criteria
Who can join
- Histologically or cytologically confirmed hormone receptor-positive advanced breast cancer patients
- Have recurrent, metastatic, or unresectable disease
- Have HER2-low expression status, defined as IHC 2+/ISH- or IHC 1+,with a validated assay by ASCO/CAP guidelines
- Have no previous history of HER2-positive breast cancer (IHC 3+ or ISH+) by ASCO/CAP guidelines
- The hormone receptor (HR) status is defined by ER/PR IHC nuclear staining, and ER or PgR ≥1% is defined as hormone receptor-positive status
- Patients who progressed on 1st line endocrine + CDK4/6 inhibitor therapy for advanced breast cancer and received no other systemic therapy for advanced breast cancer. The all FDA-approved CDK4/6 inhibitors (palbociclib...
- Patients who have received chemotherapy or adjuvant endocrine therapy in the neo-adjuvant or adjuvant setting are eligible.
- Female patients with ≥19 years of age
- Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting study treatment
- Patients must have at least one measurable lesion by RECIST 1.1 criteria, which was not previously irradiated or showed objective progression after irradiation to that lesion
- Patients must have an adequate tumor tissue sample available for assessment of HER2 by central laboratory and other exploratory biomarker analyses
- Patients with ECOG performance status 0 or 1
- Both pre- and post-menopausal patients are eligible, and pre-menopausal patients should receive ovarian function suppression treatment (GnRH agonist injection or surgical bilateral oophorectomy) while receiving...
- Adequate organ function for treatment Adequate organ and bone marrow function within 14 days before randomization/enrolment as described below:" a) Haemoglobin: ≥ 9.0 g/dL NOTE: Participants requiring ongoing...
- granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1 ) e) Platelets ≥100,000 cells/mm3
- Platelet transfusion is not allowed within 1 week prior to C1D1) f) Estimated creatinine clearance ≥50 mL/min, or serum creatinine \<1.5x institution upper limit of normal (ULN) g) Bilirubin≤1.5 x ULN
- if no liver metastases or \< 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline h) AST (SGOT) ≤2.5 x ULN (5.0 x ULN if hepatic metastases) i) ALT...
- 12-Lead electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
- QTc interval ≤470 msec and without history of Torsades de pointes based on average of the screening triplicate 12-lead ECG
- Pointes or other symptomatic QTc abnormality
- LVEF (by MUGA or echocardiogram) of ≥50% within 28 days before randomization/enrollment
- No history of pneumonitis other than radiation pneumonitis
- The patient has provided signed informed consent
- Neither pregnant or breastfeeding female patients
- Fertile women who are not in pregnancy or breastfeeding should use effective contraception for a period from two weeks before the start of research treatment, during treatment and up to seven months after last dose of...
- No other concurrent severe and/or uncontrolled medical disease which could compromise study participation, including any of the following:
- Adequate treatment washout period before enrollment are below -Major surgery ≥ 4 weeks -Radiation Therapy including palliative stereotactic radiation therapy to chest ≥ 4 weeks -Palliative stereotactic radiation therapy...
What rules you out
- Previous history of T-DXd or Dato-Dxd treatment for advanced breast cancer
- Severe Cardiac disease (e.g., uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past year, Left Ventricular Ejection Fraction...
- Patients with a medical history of myocardial infarction (MI) within 6 months before randomization/enrolment, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), people with troponin...
- Current active hepatic or biliary disease (except for Gilbert syndrome, asymptomatic gallstones, liver metastasis or stable chronic liver disease per investigator assessment)
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
- Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of T-DXd.
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline. Note: people may be enrolled with chronic, stable Grade 2 toxicities...
- Chemotherapy-induced neuropathy
- Fatigue
- Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include:
- Hypothyroidism/hyperthyroidism
- Type 1 diabetes
- Hyperglycaemia
- Adrenal insufficiency
- Adrenalitis
- Skin hypopigmentation (vitiligo)
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (i.e., pulmonary emboli within three months prior to study enrollment, severe asthma, severe...
- Has as a history of (non-infectious) ILD/ pneumonitis, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.Presence of spinal cord compression, symptomatic CNS...
- Significantly altered mental status prohibiting the understanding of the study, or with psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and...
- Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection. people with past or resolved hepatitis B virus (HBV) infection who are anti-HBc positive (+) are...
- Multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Pregnant or breast-feeding women.
- Previous allogeneic bone marrow transplant.
- Patients with a known hypersensitivity to T-DXd
- History of severe hypersensitivity reactions to other monoclonal antibodies
- Prior treatment with antibody drug conjugate that comprised an exatecan derivative that is a topoisomerase I inhibitor
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.