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New treatment option for Breast Cancer Metastatic
Official title Trial of Trastuzumab Deruxtecan in Previously Treated HER2
ClinicalTrials.gov ID: NCT06750484
What this study is testing
What is Trastuzumab Deruxtecan?
Trastuzumab Deruxtecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast cancer metastatic.
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
- The purpose of this study is to test the good and bad effects of a drug called trastuzumab deruxtecan (T-DXd) in adult patients with metastatic HER2-negative breast cancer and which patients might benefit the most from T-DXd.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Must be competent and able to comprehend, sign, and date an Institutional Review Board (IRB) approved ICF before performance of any study-specific...
- Men or women ≥18 years old.
- Pathologically documented breast cancer that is unresectable or metastatic.
- 4.Tumor biopsies have always shown HER2-IHC 0 (\<10% membrane staining, including 0 null and 0 ultralow) in all prior biopsies and never previously...
- Either HR-positive or HR-negative status of the tumor per ASCO-CAP guidelines are allowed.
You likely can't join if
- Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction within 6 months before enrolment.
- History of symptomatic congestive heart failure (New York Heart Association Class II to IV).
- Corrected QT interval (QTc) Fridericia prolongation to \>470 ms (females) or \>450 ms (male) based on average of Screening 12 lead ECG.
- Uncontrolled or significant respiratory disease criteria, including any of the following:
- Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be...
See the full eligibility criteria
Who can join
- Must be competent and able to comprehend, sign, and date an Institutional Review Board (IRB) approved ICF before performance of any study-specific procedures or tests.
- Men or women ≥18 years old.
- Pathologically documented breast cancer that is unresectable or metastatic.
- 4.Tumor biopsies have always shown HER2-IHC 0 (\<10% membrane staining, including 0 null and 0 ultralow) in all prior biopsies and never previously HER2-positive (IHC 3+ or ISH+) or HER2-low (1+, or 2+ ISH-) on prior...
- Either HR-positive or HR-negative status of the tumor per ASCO-CAP guidelines are allowed.
- Patients with HR-positive disease must have progressed or be intolerant to CDK 4/6 inhibitors plus endocrine therapy, and patients with HR-negative disease must have received 1 line of therapy in the metastatic setting...
- Patients must have never been previously treated with any anti-HER2 therapy, including prior trastuzumab deruxtecan, other HER2-directed ADCs, HER2 antibodies or HER2 tyrosine kinase inhibitors
- Clinical or radiologic progression (during or after most recent treatment) or intolerance to therapy prior to enrollment in this trial
- Adequate archival tumor sample \<3 years-old available for assessment of HER2 status by IHC and by HS-HER2 quantitative assay. If archival tissue is not available or inadequate for assessment (e.g. decalcified bone...
- Presence of at least 1 measurable lesion based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- ECOG PS ≤ 2.
- Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to C1D1.
- Adequate bone marrow function (Table 1) within 28 days before C1D1, defined as:
- Platelet count \>≥100,000/mm3 (Platelet transfusion is not allowed within 1 week prior to Screening assessment).
- Hemoglobin level ≥9.0 g/dL (red blood cell transfusion is not allowed within 1 week prior to Screening assessment).
- Absolute neutrophil count ≥1500/mm3 (granulocyte colony-stimulating factor administration is not allowed within 1 week prior to Screening assessment).
- Adequate renal function (Table 1) within 28 days before C1D1, defined as: a. Creatinine clearance ≥30 mL/min, as calculated using the Cockcroft-Gault Equation.
- Adequate hepatic function (Table 1) within 28 days before C1D1, defined as:
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3×ULN (\< 5×ULN in participants with liver metastases).
- Total bilirubin ≤1.5 × ULN if no liver metastases or \<3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
- Adequate blood clotting function( defined below) within 28 days before C1D1, defined as International normalized ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time ≤ 1.5...
- Platelet function greater than or equal to 100000/mm3 (Platelet transfusion is not allowed within 1 week prior to C1D1).
- Hemoglobin greater than or equal to 9.0 g/dL NOTE: Participants requiring ongoing transfusions or growth factor support to maintain haemoglobin ≥9.0 g/dL are not eligible. Red blood cell transfusion is not allowed...
- Absolute neutrophil count greater than or equal to 1500/mm3. (granulocyte-colony stimulating factor administration is not allowed within 1 week prior to C1D1).
- Alanine aminotransferase and aspartate aminotransferase less than or equal to 3×ULN (\< 5×ULN in participants with liver metastases).
- Total bilirubin less than or equal to 1.5×ULN if no liver metastases or \< 3×ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.
- Serum albumin greater than or equal to 2.5 g/dL
- Creatine clearance greater than or equal to 30 mL/min as determined by Cockcroft Gault (using actual body weight).
- International normalised ratio or Prothrombin time and either partial thromboplastin or activated partial thromboplastin time less than or equal to 1.5 x upper limit of normal
- Adequate treatment washout period before C1D1, defined below:
- Major surgery minimum washout period of greater than or equal to 4 weeks
- Radiation therapy including palliative stereotactic radiation therapy to chest minimum washout period greater than or equal to 4 weeks
- Palliative stereotactic radiation therapy to other anatomic areas including whole brain radiation minimum wash out period of greater than or equal 2 weeks
- Anti-Cancer chemotherapy [Immunotherapy (non-antibody based therapy)], hormonal therapy, antibody-based therapy, or retinoid therapy minimum washout period greater than or equal to 3 weeks
- Anti-Cancer chemotherapy [Immunotherapy (non-antibody based therapy)], hormonal therapy, antibody-based therapy, or retinoid therapy minimum washout period greater than or equal 3 weeks
- Targeted agents and small molecules minimum washout period greater than or equal 2 weeks or 5 half-lives, whichever is longer
- Cell-free and Concentrated Ascites Reinfusion Therapy (CART), peritoneal shunt or drainage of pleural effusion, ascites or pericardial effusion minimum washout period greater than or equal to 2 weeks prior to screening...
- Any monoclonal antibody treatment minimum washout period greater than or equal to 3 elimination half-lives of the inhibitor/antibody
- Evidence of post-menopausal status or negative serum pregnancy test for females of childbearing potential who are sexually active with a non-sterilized male partner. For women of childbearing potential, a negative...
- Female patients of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in Table 3 from the time of screening (those...
- Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom from screening to 4 months after the final dose of T-DXd. Complete heterosexual abstinence for the...
- Female people must not donate, or retrieve for their own use, ova from the time of enrolment and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should...
What rules you out
- Uncontrolled or significant cardiovascular disease, including any of the following:
- History of myocardial infarction within 6 months before enrolment.
- History of symptomatic congestive heart failure (New York Heart Association Class II to IV).
- Corrected QT interval (QTc) Fridericia prolongation to \>470 ms (females) or \>450 ms (male) based on average of Screening 12 lead ECG.
- Uncontrolled or significant respiratory disease criteria, including any of the following:
- Has a history of (noninfectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. severe asthma, severe chronic obstructive pulmonary disorder, restrictive lung disease...
- Any autoimmune, connective tissue or inflammatory disorders, including Rheumatoid arthritis, Sjogren's, and sarcoidosis, where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full...
- Prior pneumonectomy (complete)
- Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids to control associated symptoms.
- people with clinically inactive brain metastases may be included in the study.
- people with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A...
- Has history of another primary malignancy, except for:
- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- Adequately treated carcinoma in situ without evidence of disease.
- Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product, or history of severe hypersensitivity reactions to monoclonal antibodies.
- Has an uncontrolled infection requiring ongoing IV antibiotics, IV antivirals, or IV antifungals.
- Has known history of human immunodeficiency virus (HIV) infection with detectable viral load or CD4 count \< 200 cells per cubic millimeter or active hepatitis B ( HBsAg positive) or C (HCV positive RNA) infection.
- Substance abuse, medical conditions such as clinically significant cardiac or pulmonary diseases or psychological, social, familial, or geographical conditions, that would, in the opinion of the Investigators, increase...
- Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤1 or baseline. people with chronic Grade 2 toxicities may be eligible per the discretion...
- Is pregnant or breastfeeding, or planning to become pregnant.
- Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first exposure to study intervention. Note: Participants...
- Otherwise considered inappropriate for the study by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Rochester, New York, United States
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 all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New Haven, Connecticut, United States; Atlanta, Georgia, United States; Rochester, New York, United States. 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.