[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06974604":3,"trial-entities:NCT06974604":119,"trial-summary:NCT06974604":124},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":41,"secondary_outcomes":46,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":86,"locations":89,"central_contacts":109,"overall_officials":114,"references":117,"see_also_links":118},"NCT06974604","BrUOG 431","Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM","Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087)","RECRUITING","2029-05-31","2025-10","2025-10-24","2025-10-22","Brown University","OTHER",true,"TROPION-DM\u002FBrUOG-431 is a prospective, , phase 2 trial with two non-comparative cohorts analyzed jointly for primary endpoint in adult patients with either (Cohort 1:) advanced\u002Fmetastatic hormone-receptor positive (\\[HR+\\], estrogen receptor and\u002For progesterone receptor positive) breast cancer (BC), or advanced\u002Fmetastatic triple negative breast cancer (TNBC) or (Cohort 2:) advanced\u002Fmetastatic non-squamous non-small cell lung cancer (NSCLC).\n\nAll patients will be treated with Datopotumab deruxtecan (Dato-DXd) at 6 mg\u002Fkg IV every 3 weeks until disease progression or unacceptable toxicity. Due to the risk of stomatitis, the investigational component of this trial will be to incorporate alcohol-free dexamethasone mouthwash, 10 mL 0.5 mg\u002F5mL oral solution, days 1-5, swish and spit four times daily for the first 3 cycles.","See above summary",[19,20],"Breast Neoplasms","Lung Neoplasms",[22,23,24],"Advanced\u002Fmetastatic hormone-receptor positive [HR+], estrogen receptor and\u002For progesterone receptor positive","Advanced\u002Fmetastatic triple negative breast cancer","Advanced\u002Fmetastatic non-squamous, non-small cell lung cancer","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},60,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":39},"DRUG","Dexamethasone oral","Dexamethasone 10 mL daily for days 1-5 for each of the first 3 cycles of therapy Datopotamab Deruxtecan 6.0 mg\u002Fkg IV on day 1 every 21 days",[38],"Dexamethasone 10mL",[40],"Datopotamab Deruxtecan (Dato-DXd DS-1062a)",[42],{"measure":43,"description":44,"timeFrame":45},"Lower the incidence of all stomatitis","Lower the incidence of all stomatitis by 20%","Approximately 9 weeks",[47],{"measure":48,"description":49,"timeFrame":45},"Clinical benefit","Clinical benefit rate","ALL","18 Years",null,false,{"inclusion":55,"exclusion":70,"raw_text":85},[56,57,58,59,60,61,62,63,64,65,66,67,68,69],"Has advanced and\u002For metastatic cancer that meets one of the following criteria:","Aged ≥18 years.","Has an Eastern Cooperative Oncology Group performance status 0-2.","Has a left ventricular ejection fraction (LVEF) 50% by either an echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 28 days before enrollment.","Measurable disease based on Response Evaluation Criteria in Solids Tumors (RECIST) version 1.1.","Has adequate organ function that would make them an appropriate candidate for Datopotamab deruxtecan therapy as treatment of advanced metastatic cancer as assessed by the treating physician, which shall include results of complete blood count with differential, and comprehensive metabolic panel within 14 days before Cycle 1, Day 1, defined as:","Has an adequate treatment washout period prior to Cycle 1, Day 1, defined as appropriately recovering from:","If of reproductive\u002Fchild-bearing potential, agrees to use a highly effective form of contraception or avoid intercourse throughout treatment and upon completion of the study for at least 7 months for females and 4 months for males after the last dose of study drug. Highly effective methods of birth control include: combined (estrogen and progesterone containing) hormonal contraception by oral or intravaginal route or dermal patches; progesterone-only hormonal contraception associated with inhibition of ovulation given by oral route or by injections or implants; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner (with confirmation of surgical success); and complete heterosexual abstinence.","Starting at the time of randomization\u002Ffirst dose of study intervention male subjects\u002Fparticipants must not freeze or donate sperm at any time during this study and for at least 4 months after the last dose of Dato-DXd. Preservation of sperm should be considered prior to randomization\u002Ffirst dose of study intervention.","Starting at the time of randomization\u002Ffirst dose of study intervention female subjects\u002Fparticipants must not breastfeed or donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of Dato-DXd. Preservation of ova should be considered prior to randomization\u002Ffirst dose of study intervention.","Is able to provide written informed consent and is willing and able to comply with the protocol. Subject must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible toxicities) and must sign and date the Institutional Review Board (IRB)\u002FIndependent ethics committee (IEC) approved informed consent form (ICF) (including Health Insurance Portability and Accountability Act authorization \\[HIPAA\\], if applicable) before performance of any study- specific procedures or examinations.","Willingness to self-report level of oral pain using Visual Analog Scale (VAS) and the Normalcy Diet Scale (NDS) throughout each stomatitis event. (40, 41) At baseline, patient's self-reported oral pain level, using VAS, must be 0 (See Appendix B) and the normalcy diet scale score should ≥ 60 (See Appendix C).","Willingness to record oral symptoms in Oral Diary (See Appendix D).","Has a life expectancy of ≥3 months.",[71,72,73,74,75,76,77,78,79,80,81,82,83,84],"Active second malignancy which would alter interpretation of study results.","Has a history of non-infectious ILD\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.","Has clinically significant corneal disease","Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd.","Has a history of severe hypersensitivity reactions to other monoclonal antibodies.","Has ongoing radiation-related toxicities","Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.","Has active human immunodeficiency virus (HIV) infection that is not well controlled.","Has an active or uncontrolled hepatitis B and\u002For hepatitis C infection","Is lactating or pregnant as confirmed by pregnancy tests performed within 7 days before enrollment.","Clinically severe pulmonary compromise resulting from autoimmune, connective tissue or inflammatory disorders with pulmonary involvement.","Has uncontrolled or significant cardiac disease (including MI or unstable angina within the past 6 months, NYHA Class II-IV heart failure, uncontrolled hypertension, uncontrolled or significant arrhythmia).","History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes.","Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.","Inclusion Criteria:\n\n* Has advanced and\u002For metastatic cancer that meets one of the following criteria:\n\n  1. Pathologically documented unresectable advanced non-squamous NSCLC not amenable to curative therapy that has progressed on at least one prior therapy.\n  2. Pathologically documented triple negative breast cancer (estrogen receptor negative and progesterone receptor negative and HER2 negative) who have progressed on at least 1 prior line of therapy or in the opinion of the treating physician, not be a candidate for standard first-line metastatic breast cancer therapy\n  3. Pathologically documented hormone receptor positive breast cancer (estrogen receptor and\u002For progesterone receptor positive, HER2 negative) which has progressed on hormonal based therapy including CDK4\u002F6 inhibitor and 1 prior line of chemotherapy and\u002For antibody drug conjugate therapy.\n* Aged ≥18 years.\n* Has an Eastern Cooperative Oncology Group performance status 0-2.\n* Has a left ventricular ejection fraction (LVEF) 50% by either an echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 28 days before enrollment.\n* Measurable disease based on Response Evaluation Criteria in Solids Tumors (RECIST) version 1.1.\n* Has adequate organ function that would make them an appropriate candidate for Datopotamab deruxtecan therapy as treatment of advanced metastatic cancer as assessed by the treating physician, which shall include results of complete blood count with differential, and comprehensive metabolic panel within 14 days before Cycle 1, Day 1, defined as:\n\n  1. Platelet count ≥100,000\u002Fmm3\n  2. Hemoglobin ≥9.0 g\u002FdL\n  3. Absolute neutrophil count ≥1000\u002Fmm3\n  4. Creatinine clearance ≥30 mL\u002Fmin as calculated using the Cockcroft-Gault equation.\n  5. Aspartate aminotransferase ≤3 ×ULN (if liver metastases are present, ≤5 × ULN)\n  6. Alanine aminotransferase ≤3 × ULN (if liver metastases are present, ≤5 × ULN)\n  7. Total bilirubin ≤1.5 × ULN if no liver metastases or liver \\\u003C 3 if liver metastases are present.\n* Has an adequate treatment washout period prior to Cycle 1, Day 1, defined as appropriately recovering from:\n\n  1. Major surgery: ≥2 weeks (or 2 weeks for low-invasive cases \\[eg, colostomy\\]).\n  2. Radiation therapy (curative) and palliative radiation therapy to lung fields: ≥4 weeks; ≥2 weeks (palliative radiation therapy to other areas \\[ie, limited field and 10 or fewer days or fractions\\] including whole brain radiotherapy).\n  3. Hormonal therapy: ≥2 weeks\n  4. Chemotherapy (including immunotherapy \\[non-antibody based therapy\\]), and retinoid therapy: ≥2 weeks or 5 times terminal elimination half-life (T½) of the chemotherapeutic agent (whichever is longer); ≥6 weeks for nitrosoureas or mitomycin C, ≥1 week for tyrosine kinase inhibitors (TKIs)\n  5. Antibody-based anti-cancer therapy: ≥4 weeks\n  6. Chloroquine\u002Fhydroxychloroquine: \\>14 days\n* If of reproductive\u002Fchild-bearing potential, agrees to use a highly effective form of contraception or avoid intercourse throughout treatment and upon completion of the study for at least 7 months for females and 4 months for males after the last dose of study drug. Highly effective methods of birth control include: combined (estrogen and progesterone containing) hormonal contraception by oral or intravaginal route or dermal patches; progesterone-only hormonal contraception associated with inhibition of ovulation given by oral route or by injections or implants; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner (with confirmation of surgical success); and complete heterosexual abstinence.\n* Starting at the time of randomization\u002Ffirst dose of study intervention male subjects\u002Fparticipants must not freeze or donate sperm at any time during this study and for at least 4 months after the last dose of Dato-DXd. Preservation of sperm should be considered prior to randomization\u002Ffirst dose of study intervention.\n* Starting at the time of randomization\u002Ffirst dose of study intervention female subjects\u002Fparticipants must not breastfeed or donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of Dato-DXd. Preservation of ova should be considered prior to randomization\u002Ffirst dose of study intervention.\n* Is able to provide written informed consent and is willing and able to comply with the protocol. Subject must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible toxicities) and must sign and date the Institutional Review Board (IRB)\u002FIndependent ethics committee (IEC) approved informed consent form (ICF) (including Health Insurance Portability and Accountability Act authorization \\[HIPAA\\], if applicable) before performance of any study- specific procedures or examinations.\n* Willingness to self-report level of oral pain using Visual Analog Scale (VAS) and the Normalcy Diet Scale (NDS) throughout each stomatitis event. (40, 41) At baseline, patient's self-reported oral pain level, using VAS, must be 0 (See Appendix B) and the normalcy diet scale score should ≥ 60 (See Appendix C).\n* Willingness to record oral symptoms in Oral Diary (See Appendix D).\n* Has a life expectancy of ≥3 months.\n\nExclusion Criteria:\n\n* Active second malignancy which would alter interpretation of study results.\n* Has a history of non-infectious ILD\u002Fpneumonitis including radiation pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n* Has clinically significant corneal disease\n* Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd.\n* Has a history of severe hypersensitivity reactions to other monoclonal antibodies.\n* Has ongoing radiation-related toxicities\n* Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.\n* Has active human immunodeficiency virus (HIV) infection that is not well controlled.\n* Has an active or uncontrolled hepatitis B and\u002For hepatitis C infection\n* Is lactating or pregnant as confirmed by pregnancy tests performed within 7 days before enrollment.\n* Clinically severe pulmonary compromise resulting from autoimmune, connective tissue or inflammatory disorders with pulmonary involvement.\n* Has uncontrolled or significant cardiac disease (including MI or unstable angina within the past 6 months, NYHA Class II-IV heart failure, uncontrolled hypertension, uncontrolled or significant arrhythmia).\n\nPatients with the following may be enrolled based on the investigator's\u002Ftreating physician's assessment (documentation must be submitted to BrUOG). -Mean resting corrected QTcF interval \\> 470 ms.\n\n* History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes.\n* Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.",[87,88],"ADULT","OLDER_ADULT",[90],{"facility":91,"status":8,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":106},"Rhode Island and the Miriam Hospitals (Brown University Health)","Providence","Rhode Island","02903\u002F02906","United States",[97,102],{"name":98,"role":99,"phone":100,"email":101},"BrUOG","CONTACT","401-863-3000","BrUOG@brown.edu",{"name":103,"role":99,"phone":104,"email":105},"Stephanie Graff, MD","401-444-5388","sgraff1@brownhealth.org",{"lat":107,"lon":108},41.82399,-71.41283,[110,112],{"name":111,"role":99,"phone":100,"email":101},"Brown University Oncology Research Group (BrUOG)",{"name":103,"role":99,"phone":104,"email":113},"Sgraff1@brownhealth.org",[115],{"name":103,"affiliation":91,"role":116},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":120,"biomarkers":123},[121,122],"Breast Carcinoma","Lung Non-Small Cell Carcinoma",[],{"nct_id":4,"found":15,"summary":125,"prompt_version":135},{"design":126,"status":127,"heading":128,"summary":129,"follow_up":130,"word_count":131,"commitments":132,"compensation":133,"drugs_mentioned":134},"This is a Phase 2 interventional study with two groups of participants, analyzed together. It plans to enroll 60 adult patients.","completed","Preventing Stomatitis with Dexamethasone Mouthwash in Dato-DXd Treatment","This study is looking at whether a dexamethasone mouthwash can help prevent stomatitis (mouth sores) in people receiving a cancer treatment called Datopotamab Deruxtecan (Dato-DXd). You might be able to join if you have advanced breast cancer (either hormone-receptor positive, triple negative, or HER2-positive) or advanced non-small cell lung cancer that has progressed after other treatments. All participants will receive Dato-DXd and use the dexamethasone mouthwash. The main goal is to see if the mouthwash lowers the number of people who get stomatitis over about 9 weeks. This study plans to include 60 people, but its current recruitment status is unclear.","The primary endpoint for stomatitis is measured at approximately 9 weeks.",101,"You would receive Datopotamab Deruxtecan intravenously (IV) every 3 weeks and use dexamethasone mouthwash daily for the first 5 days of the first three cycles.","Not stated in the trial record.",[],"v2"]