[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Prof. Wolfgang Janni\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":98},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100467131","phase-4-combination-of-abemaciclib-and-endocrine-therapy-in-hormone-receptor-positive-her2-negative-locally-advanced-or-metastatic-breast-cancer-with-focus-on-digital-side-effect-management-100467131",false,"NCT05362760","Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management","Combination of Abemaciclib and Endocrine Therapy in Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer With Focus on Digital Side Effect Management. The MINERVA Trial - A Phase IV Trial","MINERVA","Inclusion Criteria:\n\nPatients will be included in the trial only if they meet all the following criteria:\n\n1. Have given written informed consent prior to any trial-specific procedures\n2. Are reliable, willing to be available for the duration of the trial and are willing to follow trial procedures\n3. Are female and aged ≥ 18 years\n4. Diagnosis of hormone receptor positive (HR+), HER2- breast cancer. Although not required as a protocol procedure, metastatic disease should be considered for biopsy whenever possible to reassess HR and HER2 status if clinically indicated.\n5. To fulfill the requirement for HR+ disease, a breast cancer must express, by immunohistochemistry (IHC), at least one of the hormone receptors (estrogen receptor \\[ER\\], progesterone receptor \\[PgR\\]) as defined in the relevant American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) Guidelines (Hammond et al. 2010).\n6. To fulfill the requirement of HER2- disease, a breast cancer must not demonstrate, at initial diagnosis or upon subsequent biopsy, overexpression of HER2 by either IHC or in-situ hybridization (ISH) as defined in the relevant ASCO\u002FCAP guidelines (Wolff et al. 2013).\n7. Have locally advanced recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease\n8. Indication for endocrine based therapy in the metastatic setting\n9. Have a performance status (PS) of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale\n10. If central nervous system (CNS) metastases are known these have to be stable (radiotherapy finished for more than 14 days ago, no required steroid medication with more than 4 mg Dexamethasone per day)\n11. Pre- and postmenopausal patients are allowed. Postmenopausal is defined as no menses for 12 months without an alternative medical cause. Women of Childbearing Potential (WOCBP, defined as not postmenopausal and not surgically or congenitally sterile) whose male partners are potentially fertile (e.g. no vasectomy) must use highly effective contraception methods for the duration of the trial and for at least 3 weeks after last dose of drugs used in the trial.Women of childbearing potential must use highly effective contraception methods for two years after the last dose of fulvestrant. Highly effective birth control methods that results in a failure rate of less than 1% per year include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner. Sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the trial and the preferred and usual lifestyle of the patient.\n12. No prior therapy for metastatic disease (except for first line endocrine therapy for maximal 3 months prior to start of abemaciclib therapy and if no progress occurred before study entry)\n13. Previous adjuvant endocrine therapy and (neo)adjuvant chemotherapy is allowed\n14. Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \\[CTCAE\\] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or ≤ Grade 2 peripheral neuropathy prior to registration. A washout period of at least 21 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy).\n15. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and registration.\n16. One of the following as defined by the RECIST v1. 1 (see Attachment 15.5):\n\n    1. Measurable disease. At least one measurable lesion assessable using standard techniques by Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST v1.1). Tumor evaluation according to RECIST version 1.1 (based on local assessment) has to be performed within 28 days before trial registration.\n    2. Nonmeasurable bone-only disease (must be evaluable, but not necessarily measurable by RECIST). Nonmeasurable bone-only disease may include any of the following: blastic bone lesion, lytic bone lesions without a measurable soft tissue component, or mixed lytic-blastic bone lesions without a measurable soft tissue component.\n17. The patient has adequate bone marrow and organ function evidenced by the following laboratory results: absolute neutrophil count (ANC) ≥ 1.5 × 109\u002FL, Platelet count ≥ 100 × 109\u002FL, Hemoglobin ≥ 8 g\u002FdL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.0 × ULN (≤ 3 x ULN in case of liver metastases), Total Bilirubin ≤ 1.5 × ULN (with Gilbert's syndrome max. 2 x ULN), Serum Creatinine ≤ 2.0 mg\u002Fdl or 177µmol\u002FL, Coagulation: International Normalized Ratio (INR) ≤ 1,5\n18. The patient is able to swallow oral medications\n19. Willingness to use the provided CANKADO digital health application to report side effects and patient reported outcomes (The use of the CANKADO app is not mandatory for study participation, but is strongly recommended)\n20. Negative pregnancy test before trial registration for women of child-bearing potential and highly effective contraception if the risk of conception exists and a negative serum pregnancy test within 7 days after the first dose of trial treatment. Pregnancy tests should be performed in premenopausal patients according to local standard\n\nExclusion Criteria:\n\nPatients will be included in the trial only if they meet none of the following criteria:\n\n1. Visceral crisis or life expectancy \\\u003C 6 months\n2. History of hypersensitivity reactions attributed to Abemaciclib or to other components of drug formulation\n3. Prior treatment with chemotherapy in the metastatic setting or endocrine therapy in the metastatic setting (except for first line endocrine therapy in metastatic or locally advanced disease for maximal 3 months prior to start of abemaciclib therapy and if no progress occurred before study entry)\n4. Patient not eligible for endocrine based therapy\n5. Any concurrent severe, uncontrolled systemic disease, social or psychiatric condition that might interfere with the planned treatment and with the patient's adherence to the protocol\n6. The patient has serious and\u002For uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this trial (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).\n7. Prior treatment with a CDK4\u002F6 inhibitor for metastatic or locally advanced disease (first-line treatment with a CDK 4\u002F6 inhibitor (Ribociclib\u002FPalbociclib) in the metastatic setting is allowed only if terminated due to toxicity after max 3 months and no progression occurred before study entry. Prior treatment with a CDK 4\u002F6 inhibitor in the neo-\u002Fadjuvant setting is allowed.)\n8. 8\\. Treatment with any other investigational agents within four weeks or 5 half-lives prior to trial registration, whichever is longer\n9. The patient has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest.\n10. Females who are pregnant or lactating\n11. Legal incapacity or limited legal capacity\n12. History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.\n13. The patient has active systemic bacterial infection (requiring intravenous \\[IV\\] antibiotics at time of initiating trial 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\\]. Screening is not required for enrollment.\n14. Prior systemic anti-cancer therapy within the last 21 days prior to start of trial treatment except for first-line endocrine therapy in metastatic or locally advanced disease (see above)\n15. Radiotherapy within the last 14 days prior to registration\n16. Patient has had major surgery within 14 days prior to trial registration.","FEMALE","18 Years",{"count":20,"type":21},300,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","The MINERVA Trial aims to evaluate safety, efficacy and quality of life (QoL) for the combination of Abemaciclib with an Aromatase Inhibitor or Fulvestrant in pre- and postmenopausal patients with metastatic hormone receptor positive HER2 negative breast cancer in the first line setting.\n\nSide effect monitoring and patient reported outcomes will be captured using the web- and app-based CANKADO digital health application. Via this user-friendly tool the patients can document their therapy side effects (e.g. diarrhea) and outcomes on a day-to-day basis. The capturing of side effects using the digital health application will be done additionally to the regular AE documentation.\n\nFurthermore, translational research objectives of this trial include the investigation of biomarkers (ct-DNA, germline DNA) to evaluate whether they can give insights into the reasons for response, intrinsic or acquired resistance to the combined endocrine",[27,28],"Hormone Receptor-positive Metastatic Breast Cancer","HER2-negative Metastatic Breast Cancer",[30,31,32,33,34,35],"hormone receptor-positive","HER2-negative","locally advanced\u002Fmetastatic breast cancer","abemaciclib","endocrine therapy","phase IV","RECRUITING","2025-05-13",{"date":39,"type":40},"2025-05-16","ACTUAL",{"date":42,"type":40},"2022-04-27",{"date":44,"type":21},"2029-04",{"name":46,"class":47},"Prof. Wolfgang Janni","OTHER",54,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100565546","phase-3-a-randomized-secondary-adjuvant-treatment-intervention-study-comparing-trastuzumab-deruxtecan-to-soc-therapy-in-ebc-patients-with-molecular-relapse-100565546","NCT06643585","A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse","SURVIVE HERoes - A Randomized Secondary Adjuvant Treatment Intervention Study Comparing Trastuzumab-Deruxtecan to SOC Therapy in eBC Patients With Molecular Relapse","SURVIVE HERoes","Inclusion Criteria:\n\nPatients will be eligible for study participation if they comply with the following criteria:\n\n1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.\n2. Females or males, ≥ 18 years and ≤ 75 years of age.\n3. Invasive breast carcinoma as revealed by local pathology that is either:\n\n   1. HER2-positive defined as an immunohistochemistry (IHC) score of 3+ and\u002For positive by in situ hybridization (ISH) in Her2 2+ tumors (as defined in 2018 American Society of Clinical Oncology - College of American Pathologists \\[ASCO-CAP\\] guidelines)\n   2. HER2-low defined as an immunohistochemistry (IHC) score of 1+ or an IHC score of 2+ with a mandatory negative in situ hybridization (ISH), as defined in 2018 American Society of Clinical Oncology - College of American Pathologists \\[ASCO-CAP\\] guidelines.\n4. Complete resection of the tumor with resection margins free of invasive carcinoma (R0).\n5. Participation in the SURVIVE study and evidence of molecular relapse (as assessed based on a positive ctDNA result obtained in the SURVIVE-study)\n6. No evidence of metastatic relapse as revealed by a CT-scan (Abdomen\u002FChest) and a SPECT bone scan that must be performed within 8 weeks before randomization (M0).\n7. Completion of surgery, (neo-)adjuvant chemotherapy (if applicable) and radiation therapy (if applicable, whichever occurred last) at least 6 months before randomization.\n8. Adjuvant\u002FPostneoadjuvant treatment with Trastuzumab, Pertuzumab, T-DM1, Capecitabine, Pembrolizumab, and Olaparib must be discontinued upon randomization into Arm A (treatment with trastuzumab deruxtecan). The washout periods (see Table 2) must be complied with. Endocrine therapy (i.e. Tamoxifen, Letrozol, Anastrozol, Fulvestrant or Exemestane) can be administered simultaneously to treatment with trastuzumab deruxtecan.\n9. Known HR status, per local laboratory assessment, as defined by ASCO-CAP guidelines (≥1%): HR-positive status defined by either positive estrogen receptor (ER) and\u002For positive progesterone receptor (PR) status. HR-negative status defined by both known negative ER and known negative PR\n10. Left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to randomization\n11. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at Screening\n12. Adequate organ and bone marrow function within 28 days before randomization as described in table 1. Organ and bone marrow function criteria must also be met when laboratory tests are repeated within 3 days before Cycle 1 Day 1. Transfusion (red blood cell or platelet) or G-CSF administration is not allowed within 2 weeks prior to the day on which marrow function is assessed.\n13. Adequate treatment washout period before treatment with trastuzumab deruxtecan (in case of randomization into cohort A), defined in table 2.\n14. Female subjects: 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 result for serum pregnancy test (test must have a sensitivity of at least 25 mIU\u002FmL) must be available at the screening visit and urine beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of Investigational Medicinal Product (IMP).\n\n    1. Women of childbearing potential are defined as those who are not surgically sterile (underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months without an alternative medical cause.\n    2. 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 (see 5.5.1.) from the time of screening and must agree to continue using such precautions for 7 months after the last dose of IMP. Not all methods of contraception are highly effective. Female patients must refrain from breastfeeding while on study and for 7 months after the last dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n    3. Female subjects must not donate, or retrieve for their own use, ova from the time of randomization and throughout the study treatment period, and for at least 7 months after the final study drug administration. They should refrain from breastfeeding throughout this time. Preservation of ova may be considered prior to enrollment in this study.\n15. Male subjects: Non-sterilized male patients who are sexually active with a female partner of childbearing potential must use a condom with spermicide from screening to 4 months after the final dose of IMP. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the patient's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable. It is strongly recommended for the female partners of a male patient to also use at least one highly effective method of contraception throughout this period, as described in section 5.5.1. In addition, male patients should refrain from fathering a child, or freezing or donating sperm from the time of randomization\u002Fenrolment, throughout the study and for 4 months after the last dose of IMP. Preservation of sperm should be considered prior to enrolment in this study.\n\nExclusion Criteria:\n\n1. Stage IV (metastatic) breast cancer.\n2. Patients with a history of any secondary primary malignancy are ineligible with the following exceptions:\n\n   * ipsi- or contralateral non-invasive carcinoma of the breast (DCIS)\n   * other, curatively treated in-situ disease\n   * adequately treated non-melanoma carcinoma of the skin\n3. Prior treatment with T-DXd.\n4. Combination of T-DXd with any other anti-cancer treatment is not permitted, except for endocrine therapy.\n5. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject's participation in the clinical study or evaluation of the clinical study results.\n6. Patients with a medical history of myocardial infarction (MI) within 6 months before first exposure to study intervention, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV), Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any myocardial related symptoms, should have a cardiologic consultation before enrollment to rule out MI.\n7. Corrected QT interval (QTcF) prolongation to \\> 470 msec (females) or \\> 450 msec (males) based on average of the screening triplicate 12-lead ECG.\n8. History of (non-infectious) Interstitial lung disease (ILD) \u002F pneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening.\n9. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals\n10. Active primary immunodeficiency, known uncontrolled active HIV infection or active hepatitis B or C infection. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA. Subjects should be tested for HIV prior to randomization\u002Fenrolment if required by local regulations or institutional review board (IRB)\u002Fethics committee (EC).\n11. Lung criteria:\n\n    1. Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (for example pulmonary emboli within three months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.)\n    2. Any autoimmune, connective tissue or inflammatory disorders (for example Rheumatoid arthritis, Sjogren's, sarcoidosis et cetera) where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the electronic case report form (eCRF) for patients who are included in the study.\n    3. Prior pneumonectomy (complete)\n12. Participants with past or resolved HBV infection are eligible only if they meet all of the following criteria:\n\n    * HBsAg (-) (for \\> 6 months off anti-viral treatment),\n    * Anti-HBc (+) (IgG or total Ig),\n    * HBV DNA undetectable,\n    * Liver architecture normal (absence of any liver pathology including absence of cirrhosis or fibrosis on prior imaging or biopsy,\n    * Absence of HCV co-infection or history of HCV co-infection.\n    * Access to a local Hepatitis B expert during and after the study. Such participants should be closely monitored for HBV reactivation.\n13. Receipt of live, attenuated vaccine (mRNA and replication deficient adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of T-DXd.\n\n    Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of IMP.\n14. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to Grade ≤ 1 or baseline.\n\n    Note: Toxicities related to endocrine therapy should be documented but does not lead to exclusion of patient from the study.\n\n    Also, subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to \\>Grade 2 for at least 3 months prior to first exposure to study intervention and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, such as:\n    1. Chemotherapy-induced neuropathy\n    2. Fatigue\n    3. Residual toxicities from prior immune-oncology treatment: Grade 1 or Grade 2 endocrinopathies which may include:\n\n    i. Hypothyroidism\u002Fhyperthyroidism ii. Type 1 diabetes iii. Hyperglycemia iv. Adrenal insufficiency v. Adrenalitis vi. Skin hypopigmentation (vitiligo)\n15. Known allergy or hypersensitivity to study treatment or any of the study drug excipients.\n16. History of severe hypersensitivity reactions to other monoclonal antibodies.\n17. Pregnant or breastfeeding female patients, or patients who are planning to become pregnant.","ALL","75 Years",{"count":60,"type":21},180,[62],"PHASE3","Prospective, multi-center, randomized, open label comparative Phase III study in patients with intermediate to high-risk (as defined in the SURVIVE trial) HER2-positive or HER2-low early breast cancer, who participate in the SURVIVE trial and experience a molecular relapse, as assessed based on a positive circulating tumor DNA (ctDNA) result, with 2:1 allocation to:\n\n* Arm A: Trastuzumab-Deruxtecan (i.v. 5,4 mg\u002Fkg, q3w) + endocrine therapy (if hormonal-receptor-positive) for 16 cycles or until relapse, if earlier\n* Arm B: Continuous treatment of physician's choice (may include endocrine treatment, CDK4\u002F6-Inhibition, T-DM1, Olaparib, Trastuzumab, Pertuzumab, Capecitabine or Neratinib)",[65],"Breast Cancer","2025-04-29",{"date":68,"type":40},"2025-05-02",{"date":70,"type":40},"2025-04-22",{"date":72,"type":21},"2032-04-22",{"name":46,"class":47},1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":58,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":87,"conditions":88,"keywords":89,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":74},"100489826","standard-surveillance-vs-intensive-surveillance-in-early-breast-cancer-100489826","NCT05658172","Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer","SURVIVE (Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer) - a Partially Double-blinded, Multi-center, Randomized, Controlled Superiority Study","SURVIVE","Inclusion Criteria:\n\n1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.\n2. Unilateral or bilateral primary invasive carcinoma of the breast, confirmed histologically.\n3. Patients with intermediate- to high-risk early breast cancer defined as either\n\n   * an indication for (neo-)adjuvant chemotherapy (regardless whether performed or not), and\u002For\n   * Large tumor (\\> 50 mm), and\u002For\n   * Positive lymph nodes, and\u002For\n   * High grade (\\>= G3). Indication to (neo-)adjuvant chemotherapy is seen as stated in the German S3 guideline for breast cancer as well as stated in the guidelines from the AGO.\n4. A complete resection of the primary tumor, with resection margins free of invasive carcinoma.\n5. Completion of primary anti-tumor therapy (adjuvant chemotherapy, surgery or radiotherapy, whichever occurs last) at least 4 weeks but no more than 24 months previously. Enrollment of patients during any kind of adjuvant therapy except chemotherapy (e.g., but not limited to endocrine therapy, antibody therapy, CDK4\u002F6-inhibitors, PARP inhibitors, PI3K inhibitors, antibody-drug conjugates and other novel agents) is allowed.\n6. Availability of primary tumor tissue from core biopsy or surgical removed tissue (FFPE Slide (≥ 6 mm³, min. 10 slides, thickness: 5 µm-10 µm, area \\>150 mm² and 1 H\\&E stained slide, minimum 20% tumor content) or FFPE Block (≥ 6 mm³ thickness: 100 µm, area: \\>150 mm² and 1 H\\&E stained slide, minimum 20% tumor content) or Genomic DNA extracted from FFPE slides or block (≥ 600 ng, Minimum volume: 25 µL, concentration: 20 ng\u002FµL, buffer: 10 mM Tris pH 8, 1 mM EDTA)) at timepoint of enrollment.\n\n   * Patients with primary systemic therapy: tissue from core biopsy\n   * Patients receiving surgery as primary therapy: surgically removed cancer tissue.\n7. No current clinical evidence for distant metastases.\n8. Females or males ≥ 18 years and ≤ 75 years of age.\n9. Performance status ≤ 1, Eastern Cooperative Oncology Group (ECOG) scale.\n10. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n\nExclusion Criteria:\n\n1. Patients with a history of any secondary primary malignancy are ineligible with the following exceptions:\n\n   * in situ carcinoma of the cervix or\n   * adequately treated basal cell carcinoma of the skin or\n   * ipsi- or contralateral non-invasive carcinoma of the breast (DCIS).\n2. Patients in pregnancy or breastfeeding. If a patient gets pregnant during the participation in the interventional phase of the study (Year 1-5), an end of intervention visit will be scheduled and the patient will enter the follow-up phase of the study. Pregnancy during the follow-up phase of the study is to be reported but does not lead to an exclusion of the study.\n3. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.\n4. Renal insufficiency with GFR \\\u003C 30 mL\u002Fmin.\n5. Previous or concomitant cytotoxic or other systemic antineoplastic treatment that is not used for treating the primary breast cancer.",{"count":84,"type":21},3500,[86],"NA","The goal of this clinical study is to evaluate the potential benefits of intensified surveillance versus standard surveillance in medium-risk and high-risk early breast cancer patients.\n\nThe main questions it aims to answer are:\n\n* Comparison of the 5-year ob´verall survival rates between patients in the Standard Surveillance arm versus patients in the liquid-biopsy guided Intensive Surveillance arm\n* Determination of the Overall Lead Time Effect generated due to tumor marker\u002FCTC\u002FctDNA guided Intensive Surveillance compared to Standard Surveillance after primary therapy in early breast cancer patients.\n\nParticipants will recieve regular blood drawals. Solely the blood samples of the intensive surveillance arm will be analysed for prospective tumor markers\u002FCTCs\u002FctDNAs. Abnormal findings of either marker will trigger diagnostic imaging to search for possible metastases. The blood samples of the standard surveillance arm will solely be biobanked for future research purposes.",[65],[90,91],"medium risk","high risk",{"date":68,"type":40},{"date":94,"type":40},"2022-12-07",{"date":96,"type":21},"2035-12",{"name":46,"class":47},""]