[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04703244":3,"trial-entities:NCT04703244":102,"trial-summary:NCT04703244":106},{"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":25,"interventions":28,"primary_outcomes":33,"secondary_outcomes":37,"sex":52,"minimum_age":53,"maximum_age":23,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":72,"locations":75,"central_contacts":95,"overall_officials":97,"references":100,"see_also_links":101},"NCT04703244","MC1933","Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer","Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer Who Have Residual Disease After Neoadjuvant Systemic Therapy","RECRUITING","2042-01-15","2026-02","2026-03-03","2021-01-13","Mayo Clinic","OTHER",false,"Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (\\>50%) risk of future life-threatening recurrences and death.","This study is being done to collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed. We will use the blood and tissue for future studies. These studies will try to find ways to treat future breast cancer patients.\n\nBecause there is cancer left in your body after breast cancer treatment is finished, we think the cancer may be different than other cancers. Tissue from surgery will be used to try to grow that kind of cancer in the lab so we can find out more about it and how to treat it.\n\nBlood samples will be used to look at measurements of biomarkers to see how this cancer is different and seek new ways to identify and treat it.",[19,20],"Breast Cancer","Residual",[],"OBSERVATIONAL",null,[],{"count":26,"type":27},999,"ESTIMATED",[29],{"type":30,"name":31,"description":32},"PROCEDURE","chemotherapy or endocrine therapy for breast cancer","Collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed.",[34],{"measure":35,"timeFrame":36},"Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy","Up to 12 months until death or a maximum of 20 years post registration",[38,40,42,44,46,48,50],{"measure":39,"timeFrame":36},"Utilize patient derived xenografts (PDX) models to study new drugs\u002Fdrug combinations",{"measure":41,"timeFrame":36},"Utilize patient derived xenografts (PDX) models to identify mechanisms of treatment resistance",{"measure":43,"timeFrame":36},"Correlate the association between Cell Free DNA (cfDNA), Circulating Tumor Cells (CTCs) and circulating immune cell subpopulations (as measured by CyTOF) with residual cancer burden",{"measure":45,"timeFrame":36},"Correlate the association between Cell Free DNA (cfDNA) with residual cancer burden",{"measure":47,"timeFrame":36},"Correlate the association between Circulating Tumor Cells (CTCs) with residual cancer burden",{"measure":49,"timeFrame":36},"Correlate the association between circulating immune cell subpopulations (as measured by Cytometry by time-of-flight (CyTOF) with residual cancer burden",{"measure":51,"timeFrame":36},"Generate autologous co-culture systems of peripheral blood immune cells and breast cancer tumor cells to study the endogenous antitumor immune response","ALL","18 Years",{"inclusion":55,"exclusion":68,"raw_text":71},[56,57,58,59,60,61,62,63,64,65,66,67],"Age ≥18 years.","Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy.","Surgically resectable disease following neoadjuvant systemic treatment.","At least one of the following must be true:","Received at least 2 weeks of neoadjuvant endocrine therapy","Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging","Began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by MRI, ultrasound, or physical examination","Provide written informed consent.","Willing to return to enrolling institution for breast cancer surgery.","Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.","Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.","Willingness to provide mandatory tissue specimens for the generation of PDX and organoids to be used future research on breast cancer at Mayo Clinic.",[69,70],"Ineligible for surgery.","History of prior malignancy \\\u003C3 years prior to registration. Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix).","Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy.\n* Surgically resectable disease following neoadjuvant systemic treatment.\n* At least one of the following must be true:\n\n  * Received at least 2 weeks of neoadjuvant endocrine therapy\n  * Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging\n  * Began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by MRI, ultrasound, or physical examination\n* Provide written informed consent.\n* Willing to return to enrolling institution for breast cancer surgery.\n* Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic.\n* Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic.\n* Willingness to provide mandatory tissue specimens for the generation of PDX and organoids to be used future research on breast cancer at Mayo Clinic.\n\nExclusion Criteria:\n\n* Ineligible for surgery.\n* History of prior malignancy \\\u003C3 years prior to registration. Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix).",[73,74],"ADULT","OLDER_ADULT",[76],{"facility":13,"status":8,"city":77,"state":78,"zip":79,"country":80,"contacts":81,"geoPoint":92},"Rochester","Minnesota","55905","United States",[82,87,90],{"name":83,"role":84,"phone":85,"email":86},"Clinical Trials Referral Office","CONTACT","855-776-0015","mayocliniccancerstudies@mayo.edu",{"name":88,"role":89},"Judy C. Boughey, M.D.","PRINCIPAL_INVESTIGATOR",{"name":91,"role":89},"Matthew P. Goetz, M.D.",{"lat":93,"lon":94},44.02163,-92.4699,[96],{"name":83,"role":84,"phone":85,"email":86},[98,99],{"name":88,"affiliation":13,"role":89},{"name":91,"affiliation":13,"role":89},[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Breast Carcinoma",[],{"nct_id":4,"found":107,"summary":108,"prompt_version":118},true,{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an observational study with a planned enrollment of 999 participants. It is not a treatment study but focuses on collecting samples for future research.","completed","Observational Study for Breast Cancer After Chemotherapy or Endocrine Therapy","This observational study is for breast cancer patients who have residual (remaining) cancer after completing chemotherapy or endocrine therapy. The study aims to collect blood and leftover surgical tissue from you to create patient-derived xenografts (PDX) and organoids. These are models grown in the lab that help researchers understand your specific cancer better. The goal is to find new ways to treat breast cancer, especially for patients who still have cancer after initial treatments. The study will follow the progress of these lab models for up to 20 years to see how they develop. We are looking for about 999 participants, but the current recruitment status is unclear.","The primary endpoint, generating PDX and organoids, will be measured for up to 12 months until death or a maximum of 20 years post-registration.",108,"You would provide blood samples and leftover surgical tissue from your breast cancer surgery. The study does not specify additional visits or procedures beyond these collections.","Not stated in the trial record.",[],"v2"]