[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04360330":3,"trial-entities:NCT04360330":93,"trial-summary:NCT04360330":97},{"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":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":43,"sex":59,"minimum_age":60,"maximum_age":17,"healthy_volunteers":61,"eligibility_criteria":62,"std_ages":66,"locations":69,"central_contacts":87,"overall_officials":89,"references":91,"see_also_links":92},"NCT04360330","20190283","SABER Study for Selected Early Stage Breast Cancer","Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer","RECRUITING","2029-05-31","2026-07","2026-08-03","2020-08-05","University of Miami","OTHER",true,"The purpose of this study is to find the most effective dose of radiation therapy to give to breast tumors in a shorter period of time, prior to standard partial mastectomy\u002Faxillary surgery.",null,[19,20],"Breast Cancer","Early-stage Breast Cancer",[19,20],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},18,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":36},"RADIATION","Stereotactic Ablative Breast Radiotherapy","Preoperative SABER: Participants will be treated with an assigned dose level of preoperative SABER, delivered in once a day, 5 fractions given on non-consecutive days, over a period of 2 weeks. In this phase I study, starting with dose level II, a dose level of preoperative SABER will be assigned per study dose-escalation design, treating 2 to 6 patients per dose level. The tested doses are the following:\n\n* Dose Level I: 35 Gy (5 fractions of 7 Gy)\n* Dose Level II (Starting Dose): 40 Gy (5 fractions of 8 Gy)\n* Dose Level III: 45 Gy (5 fractions of 9 Gy)\n* Dose Level IV: 50 Gy (5 fractions of 10 Gy)",[35],"Preoperative SABER",[37],"SABER",[39],{"measure":40,"description":41,"timeFrame":42},"Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER","The recommended phase 2 dose (RP2D) of pre-operative SABER therapy will be established as the highest dose level tested for which no more than 1 out of 6 patients experience dose-limiting toxicity (DLT). Adverse Events (AEs) including DLTs will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0","Up to 13 Weeks",[44,48,52,56],{"measure":45,"description":46,"timeFrame":47},"Number of Participants Experiencing Treatment-Related Toxicity","Number of participants experiencing treatment-related toxicity by type and grade including adverse event (AEs), serious adverse events (SAEs) and dose-limiting toxicities (DLTs). Toxicity will be evaluated using the NCI CTCAE version 5.0.","Up to 13 weeks",{"measure":49,"description":50,"timeFrame":51},"Percentage of participants with Complete Pathological Response (pCR)","pCR will be defined as a negative pathologic specimen for invasive carcinoma. The specimen used for evaluation will be the tissue samples obtained from standard of care partial mastectomy and axillary surgery as per discretion of treating physician.","Up to 9 weeks",{"measure":53,"description":54,"timeFrame":55},"Cosmesis Evaluation","Participant cosmesis will be evaluated-by-physician at 1, 6,12 and 24 months post-SABER therapy and post-surgical follow-up, using the Harvard 4-point ordinal scale (excellent, good, fair, and poor).","1, 6 ,12 and 24 months post-therapy, up to 2.5 years",{"measure":57,"description":58,"timeFrame":55},"Participant-Reported Health-Related Quality of Life (HR-QoL)","The Breast Cancer Treatment Outcome Scale (BCTOS) questionnaire will be used to assess participant-reported health-related quality of life (HR-QoL) at 1, 6 12, 24 months post-SABER therapy and post-surgical follow up.","FEMALE","50 Years",false,{"inclusion":63,"exclusion":64,"raw_text":65},[],[],"Inclusion Criteria:\n\n1. Female, ≥ 50 years of age.\n2. Oncotype or MammaPrint diagnosis results are required prior to the start of treatment\n3. Histologically confirmed invasive breast cancer.\n4. Clinical stage T1N0M0.\n5. Receptor status: Estrogen-Receptor (ER)\u002FProgesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative.\n6. Unifocal breast cancer.\n7. Eastern Cooperative Oncology Group (ECOG) 0, 1.\n8. Ability to undergo MRI.\n9. Women of child-bearing potential (WOCBP) must agree to use adequate contraception or agree to undergo sexual abstinence prior to study entry and for the duration of study participation. WOCBP must have a negative serum or urine pregnancy test at time of enrollment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.\n10. Ability to understand the investigational nature, potential risks and benefits of the research study and willingness to sign the written informed consent and HIPAA document(s).\n\nExclusion Criteria:\n\n1. Patients without histologically confirmed invasive breast cancer.\n2. Patients without Oncotype or MammaPrint diagnosis results at the start of treatment.\n3. Patients with metastatic disease.\n4. ECOG 2, 3, 4.\n5. Patients that are unable to undergo MRI.\n6. Prior history of radiation to the chest.\n7. History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis).\n8. Any serious medical or psychiatric illness\u002Fcondition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements\u002Ftreatment.\n9. Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer.\n10. Patients unable to consent, who are pregnant or nursing, or are prisoners.",[67,68],"ADULT","OLDER_ADULT",[70],{"facility":13,"status":8,"city":71,"state":72,"zip":73,"country":74,"contacts":75,"geoPoint":84},"Miami","Florida","33136","United States",[76,81],{"name":77,"role":78,"phone":79,"email":80},"Zuzel Rodriguez","CONTACT","305-243-0124","z.rodriguez1@med.miami.edu",{"name":82,"role":83},"Cristiane Takita, MD, MBA","PRINCIPAL_INVESTIGATOR",{"lat":85,"lon":86},25.77427,-80.19366,[88],{"name":77,"role":78,"phone":79,"email":80},[90],{"name":82,"affiliation":13,"role":83},[],[],{"nct_id":4,"conditions":94,"biomarkers":96},[95],"Breast Carcinoma",[],{"nct_id":4,"found":15,"summary":98,"prompt_version":108},{"design":99,"status":100,"heading":101,"summary":102,"follow_up":103,"word_count":104,"commitments":105,"compensation":106,"drugs_mentioned":107},"This is an interventional study, meaning participants will receive a specific treatment. It aims to enroll 18 women.","completed","SABER Study for Early Stage Breast Cancer","This study is testing a new way to give radiation therapy called Stereotactic Ablative Breast Radiotherapy (SABER) to women with early-stage breast cancer. The goal is to find the best dose of SABER to give before surgery, in a shorter amount of time. Researchers will be looking for the recommended dose of SABER within 13 weeks. To join, you must be a woman at least 50 years old with early-stage breast cancer that is ER\u002FPR positive and HER2 negative. Your Oncotype or MammaPrint results are also needed. The study is currently unclear on its recruitment status and plans to enroll 18 participants.","The primary endpoint, finding the recommended dose, is measured up to 13 weeks.",102,"Participants will receive SABER radiation therapy in 5 sessions over 2 weeks, given on non-consecutive days. This will happen before standard partial mastectomy\u002Faxillary surgery.","Not stated in the trial record.",[32],"v2"]