[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hr-positive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hr-positive":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100625852","phase-2-pragmatic-study-to-optimize-neoadjuvant-treatment-and-surgical-de-escalation-in-hrher2--early-breast-cancer-using-oncotype-dx-and-abemaciclib-100625852",false,"NCT07428018","Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+\u002FHER2- Early Breast Cancer Using Oncotype DX and Abemaciclib","The VIOLET Trial: A Pragmatic Phase II Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+\u002FHER2- Early Breast Cancer Using Oncotype DX and Abemaciclib","VIOLET","Inclusion Criteria:\n\n* female aged 18 years or older\n* primary, histologically confirmed diagnosis of invasive breast carcinoma,\n* estrogen receptor (ER)-positive tumor, defined as ≥10% by immunohistochemistry and measured as per ASCO\u002FCAP guidelines (Allison et al.2020). Any progesterone receptor expression is acceptable (as per local assessment)\n* documented human epidermal growth factor receptor-2 (HER2)-negative tumor as per ASCO\u002FCAP guidelines, assessed locally,\n* stage II-IIIB as per AJCC TNM classification (8th edition). Absence of distant metastases (with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure),\n* candidate to receive neoadjuvant chemotherapy according to the indication of a multidisciplinary tumor board,\n* not eligible to receive upfront breast conservative surgery (but considered potentially eligible to receive a BCS in case of tumor downstaging) AND\u002FOR not candidate to sentinel lymph node dissection because of clinical node positive disease\n* Eastern Cooperative Oncology Group Performance Status 0-1,\n* The patient is able to swallow oral medications\n* normal hematologic parameters:\n\n  a.) absolute neutrophil count ≥ ≥1500\u002Fmm3 (1.5 × 10 9\u002FL), b) platelets ≥ 100 × 10 9\u002FL, c)hemoglobin ≥ 8 g\u002FdL (≥ 80 g\u002FL)). Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion\n* normal renal function: serum creatinine concentration ≤1.5 ULN or calculated clearance ≥50 mL\u002Fmin according to the Cockcroft-Gault formula,\n* normal liver function:\n\n  a.)serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted., b)AST and ALT ≤ 3 × ULN, c)alkaline phosphatase ≤ 2.5 × ULN,\n* women of child bearing potential must have documented negative pregnancy test within 2 weeks (preferably 7 days) prior to study entry and must agree to effective non-hormonal contraception (barrier method - condoms, diaphragm -also in conjunction with spermicidal jelly, or total abstinence) after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed during the trial,\n* willingness to undergo breast surgery after optimal neoadjuvant treatment, and to provide blood and tumor samples for the study purposes, including the submission for central assessment of Oncotype Dx test.\n\nExclusion Criteria:\n\n* presence of distant metastases (stage IV) or stage IIIC disease,\n* inflammatory or locally-advanced, inoperable breast cancer\n* previous invasive ipsilateral breast cancer at any time,\n* previous or concomitant invasive malignancy. The exceptions are patients with the following (and only the following) malignancies (previous or concomitant), if adequately treated:\n\n  1. basal or squamous cell carcinoma of the skin,\n  2. melanoma in situ,\n  3. in situ non-breast carcinoma without invasion,\n  4. contra- or ipsilateral in situ breast carcinoma,\n  5. non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence,\n  6. stage I papillary thyroid cancer,\n  7. stage Ia carcinoma of the cervix,\n  8. stage Ia or b endometrioid endometrial cancer,\n  9. borderline or stage I ovarian cancer\n* known history of uncontrolled or symptomatic angina, uncontrolled hypertension (≥ 180\u002F110 mmHg), uncontrolled diabetes mellitus, dyspnea at rest, chronic therapy with oxygen, a New York Heart Association (NYHA) class III or IV congestive heart failure, syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest\n* females who are pregnant or lactating (lactation has to stop before study entry)\n* the patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment \\[e.g. estimated creatinine clearance \\\u003C30ml\u002Fmin\\], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea),\n* The patient has had major surgery within 14 days prior to study entry.\n* The patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to study entry, or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.\n* The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \\[for example, hepatitis B surface antigen positive\\])\n* contraindications or known hypersensitivity to the trial medication or excipients,\n* use of any anti-cancer investigational agents within 30 days prior to expected start of trial treatment","FEMALE","18 Years","90 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)\u002FHER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and\u002For sentinel node biopsy",[28,29,30,31],"Breast Cancer","HER2 + Breast Cancer","HR Positive","Neoadjuvant Therapy",[33,34,35,36,37],"breast","oncotype dx","abemaciclib","neoadjuvant treatment","surgical deescalation","NOT_YET_RECRUITING","2026-03-03",{"date":41,"type":42},"2026-03-05","ACTUAL",{"date":44,"type":22},"2026-04-30",{"date":46,"type":22},"2029-04-30",{"name":48,"class":49},"Mario Negri Institute for Pharmacological Research","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":86,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100505964","phase-1-pre-i-spy-phase-iib-oncology-platform-program-100505964","NCT05868226","PRE-I-SPY Phase I\u002FIb Oncology Platform Program","PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I\u002FIb Platform Trial","PRE-I-SPY-PI","General Inclusion Criteria (GIC):\n\n* GIC1: The participant must have ability to understand and willingness to provide signed written informed consent prior to any study related assessments and procedures and for collection of archival FFPE blocks (freshly cut 14 unstained tumor slides would be acceptable).\n* GIC2: Age ≥ 18 years at the time of signing the informed consent\n* GIC3: Gender: Male or female (premenopausal and postmenopausal)\n* GIC4: ECOG performance status Grade 0-2\n* GIC5: Estimated life expectancy \\> 12 weeks at the start of investigational medicinal product (IMP) treatment.\n* GIC6: Adequate organ function, evidenced by the following laboratory results within 30 days of the start of IMP:\n\n  * Absolute neutrophil count ≥ 1,500\u002Fmm3\n  * Platelet count ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9.0 g\u002FdL with no blood transfusion in the past 28 days\n  * Total bilirubin ≤ 1.5 x the upper limit of normal (ULN)\n  * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN\n  * Estimated Creatinine clearance (using Cockcroft-Gault formula) ≥ 60 mL\u002Fmin for small molecules and \\>30 mL\u002Fmin for monoclonal antibodies unless otherwise specified in the Arm Specific Eligibility.\n\nThese cut-off values may be modified with supporting data for specific drug regimens.\n\n* GIC7: Non-Pregnant: Serum or urine pregnancy test must be negative within 14 days of IMP treatment start in women of childbearing potential. Pregnancy testing does not need to be pursued in patients who are judged as postmenopausal before enrollment, or who have undergone bilateral oophorectomy, total hysterectomy, or bilateral tubal ligation. If male, they must agree to refrain from donating sperm during treatment.\n* GIC8: Contraception: Women of childbearing potential and men must be willing to use adequate contraception for the duration of protocol treatment. Additional information regarding contraception for the specific treatment arm will be added to the drug arm description. Adequate contraception is defined as one highly effective form (i.e., abstinence, (fe)male sterilization) OR two effective forms (e.g., non-hormonal IUD and condom \u002F occlusive cap with spermicidal foam \u002F gel \u002F film \u002F cream \u002F suppository).\n* GIC9: Prior therapy effects: Resolution of all acute toxic effects of prior therapy, including radiotherapy, to grade ≤1 and neuropathy to grade ≤2 (except toxicities not considered a safety risk for the patient) and recovery from surgical procedures.\n* GIC10: Participant compliance: Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Additional arm specific inclusion criteria as needed by drug arm regimen\n\nGeneral Exclusion Criteria (GEC):\n\n* GEC1: Wash out periods: No other anticancer therapy within the following periods:\n\n  * chemotherapy or investigational agents, 3 weeks\n  * mitomycin C and nitrosoureas, 6 weeks\n  * radiotherapy, 3 weeks\n  * targeted therapy, 2 weeks\n  * MAbs, ADCs, and immunotherapy, 3 weeks\n  * endocrine therapy, no washout needed\n* GEC2: Concurrent therapy with other Investigational Products.\n* GEC3: Prior history of drug\u002Fregimen hypersensitivity: History of infusion-related reactions and\u002For hypersensitivity to IMP or excipients of the study drug\u002Fdrugs which led to permanent discontinuation of the treatment.\n* GEC4: Uncontrolled intercurrent illness including (active infection, diabetes, pulmonary embolism in the past 6 months, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements).\n* GEC5: Cardiovascular disease: History (within 6 months prior to start IMP) of clinically significant cardiovascular disease such as unstable angina, congestive heart failure (CHF), myocardial infarction, uncontrolled hypertension, cardiac arrhythmia requiring medication, or baseline corrected QT by Fridericia's formula (QTcF) length \\> 470 msec for men and women. The QTcF cut-off value may be modified with supporting data for specific drug regimens.\n* GEC6: CNS tumoral spread: Active uncontrolled\u002Fsymptomatic central nervous system cancer\u002Fspinal cord compression. Previously treated and clinically stable lesions, as per Investigator's judgment, are permitted. Newly discovered asymptomatic lesions that are not life threatening and do not require urgent local treatment to ensure patient safety, after consultation with study regimen chaperones, may be permitted.\n* GEC7: Liver disease: Patients with clinically significant history of liver disease, including viral or other known hepatitis, current alcohol abuse, or cirrhosis.\n* GEC8: Recent major surgery within 4 weeks prior to start IMP treatment\n* GEC9: Pregnancy or breastfeeding\n* GEC10: Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.\n* GEC11: Other conditions, which in the opinion of the investigator, would compromise the safety of the patient or the patient's ability to complete the study.\n* GEC12: Concomitant malignancies: A diagnosis of a malignancy in the 2 years prior to starting study treatment other than the disease under study. Exceptions include indolent or definitively treated malignancy not expected to require treatment during the study, affect the safety of subjects, or affect the endpoints of the trial.\n* Additional arm specific exclusion criteria as needed by drug arm regimen","ALL",{"count":61,"type":22},124,[63],"PHASE1","I-SPY Phase I\u002FIb (I-SPY-P1) is an open-label, multisite platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the I-SPY 2 SMART Design Trial (NCT01042379) and\u002For other oncology-based trials in a timely manner.",[66,67,68,69,70,71,72,73,74,30,75,76,77,78,79,80,81,82,83,84,85],"HER2-positive Breast Cancer","Metastatic Cancer","Metastatic Breast Cancer","Metastatic","HER2-positive Metastatic Breast Cancer","HER2 Mutation-Related Tumors","HER-2 Protein Overexpression","HER2-negative Breast Cancer","Triple Negative Breast Cancer","Hormone Receptor-positive Breast Cancer","Estrogen Receptor Positive Tumor","Progesterone Receptor-positive Breast Cancer","Hormone Receptor Negative Breast Carcinoma","Solid Tumor","Solid Tumor, Adult","Solid Carcinoma","HER2 Low Breast Cancer","HER2 Low Breast Carcinoma","ER Positive Breast Cancer","PR-positive Breast Cancer",[87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120],"I-SPY Trials","Quantum Leap Healthcare Collaborative","QLHC","I-SPY","I-SPY2","I-SPY1","PRE-ISPY","PRE-I-SPY","I-SPY Phase 1","I-SPY Phase 1b","I-SPY-P1","ISPY","ISPYP1","I-SPY Phase 1 Platform","ISPY2","ISPY1","Phase 1 Platform","Phase 1 Oncology Platform","T-DXd naive","PRE1","PRE2","PRE3","PRE","PRE-I-SPY Phase 1","PRE-I-SPY Phase 1b","ALX148","T-DXd","Enhertu","Zanidatamab","Tucatinib","Ziihera","Tukysa","Evorpacept","QL","RECRUITING","2025-04-01",{"date":124,"type":42},"2025-04-04",{"date":126,"type":42},"2023-02-15",{"date":128,"type":22},"2029-12-30",{"name":130,"class":49},"QuantumLeap Healthcare Collaborative",7]