[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"GBG Forschungs GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":129},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,73,98],{"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":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100531548","phase-2-evaluating-the-addition-of-elacestrant-oral-serd-to-olaparib-parp-inhibitor-in-patients-with-advancedmetastatic-hrher2--breast-cancer-100531548",false,"NCT06201234","Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced\u002FMetastatic HR+\u002FHER2- Breast Cancer","Phase II Study Evaluating the Addition of Elacestrant, an Oral Selective Estrogen Receptor Degrader (SERD), to Standard-of-care Olaparib in Patients With Hormone Receptor (HR)-Positive, HER2-negative Locally Advanced or Metastatic Breast Cancer With gBRCA1\u002F2 Mutations","ELEMENT","Inclusion Criteria:\n\nPatients will be eligible for study participation only if they comply with the following criteria:\n\n1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for scheduled visit, the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.\n2. Female or male patients.\n3. Age at study entry of at least 18 years.\n4. Locally advanced or metastatic breast cancer that is HR-positive (ER and\u002For PgR ≥ 10% of stained cells at IHC) and HER2-negative (IHC 0 or 1+, or 2+ and ISH negative according to ASCO\u002FCAP guidelines).\n5. Patients with deleterious or suspected deleterious gBRCA1\u002F2 mutation detected upon local testing.\n6. Willingness and ability to provide archived formalin fixed paraffin embedded tissue (FFPE) block or a partial block from archived tumor or metastasis.\n7. Indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib.\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.\n9. Resolution of all acute toxic effects of prior anti-cancer therapy including endocrine therapy or surgical procedures to NCI CTCAE version 5.0 grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).\n10. Life-expectancy \\> 6 months.\n11. For female patients: patients of childbearing potential (defined as not post-menopausal and not permanently sterile \\[latter defined as having undergone hysterectomy, bilateral salpingectomy, or bilateral oophorectomy\\]) require a negative serum or urinary pregnancy test within 72 hours before starting treatment in this study (in this case, patients need to use highly effective non-hormonal contraceptive methods as specified in the protocol).\n\nFor male patients: during the intervention period and for at least 120 days after the last dose of elacestrant, patients should refrain from heterosexual intercourse or use a condom (and should also be advised of the benefit for a female partner to use a highly effective method of contraception as a condom may break or leak), and they should refrain from donating sperm.\n\nExclusion Criteria:\n\nPatients will be ineligible for study participation if they fulfill any of the following criteria:\n\n1. Known hypersensitivity reaction to one of the compounds, excipients, or substances used in this protocol.\n2. Active or newly diagnosed CNS metastases, including leptomeningeal carcinomatosis, carcinomatous meningitis, or radiographic signs of CNS hemorrhage. Note: Patients with stable brain metastases are allowed. Radiotherapeutic treatment must be completed 1 week before planned day 1 of study therapy.\n3. Presence of symptomatic metastatic visceral disease that are at risk of life-threatening complications in the short term, including but not confined to massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis, or fulminant liver involvement.\n4. Inadequate organ function prior to enrolment including:\n\n   * Hemoglobin \\\u003C 9 g\u002FdL (\\\u003C 5.6 mmol\u002FL)\n   * Absolute neutrophil count (ANC) \\\u003C 1500\u002Fmm³ (\\\u003C 1.5 x 109\u002FL)\n   * Platelets \\\u003C 100,000\u002Fmm³ (\\\u003C 100 x 109\u002FL)\n   * Alanine aminotransferase (ALT\u002FSGPT) and\u002For aspartate aminotransferase (AST\u002FSGOT) \\> 3 x upper normal limits (ULN). If the patient has liver metastases, ALT and AST should not be ≥ 5 x ULN.\n   * Alkaline phosphatase (ALP) \\> 2.5 x ULN\n   * Total serum bilirubin \\> 1.5 x ULN (exception: patients with Gilbert's syndrome permitted up to ≤ 3 x ULN)\n   * Serum creatinine \\> 1.5 x ULN or estimated creatinine clearance \\\u003C 50 mL\u002Fmin as calculated using the standard method for the institution.\n5. Existing contraindication against the use of the elacestrant or olaparib.\n6. Prior treatment with PARP inhibitors.\n7. Female patients: pregnancy or lactation at the time of randomization or intention to become pregnant during the study and for a predefined period after the end of treatment (as described in protocol).\n\n   Male patients: intention to get a child during the study and for a predefined period after the end of treatment (as described in protocol).\n\n   According to the treatment received during the study, required contraception timelines for female and male patients are described in the study protocol.\n8. Any of the following within 6 months prior to enrolment: myocardial infarction, severe\u002Funstable angina, ongoing grade ≥ 2 cardiac dysrhythmias, prolonged QT corrected by Fridericia's formula (QTcF) grade ≥ 2, uncontrolled atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, heart failure of New York Heart Association (NYHA) Class II or greater, or cerebrovascular accident including transient ischemic attack.\n9. Uncontrolled hypertension at the time of screening (systolic BP \\> 140 mmHg or diastolic BP \\> 90 mmHg that has not been adequately treated or controlled).\n10. Active and current anticoagulation for treatment purposes of thrombotic events occurring \\\u003C 6 months before enrolment is not allowed (prophylactic anticoagulation, however, is acceptable). Treatment with an anticoagulant for a thrombotic event occurring \\> 6 months before enrolment, or for an otherwise stable and allowed medical condition (e.g., well controlled atrial fibrillation) is acceptable, provided dose and coagulation parameters (as defined by local standard of care) are stable for at least 28 days prior to the first dose of study drug.\n11. Known difficulty in tolerating oral medications or conditions which would impair absorption of oral medications such as: uncontrolled nausea or vomiting (i.e., CTCAE ≥ grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction\u002Fmotility disorder, malabsorption syndrome, or prior gastric bypass.\n12. History of endometrial intraepithelial neoplasia in patients who have not undergone a hysterectomy.\n13. Malignant disease other than breast cancer, active or being disease-free for less than 5 years (except carcinoma in situ of the cervix, DCIS, and non-melanomatous skin cancer adequately treated).\n14. Uncontrolled significant active infections including HBV, HCV, and\u002For HIV. Patients with a positive hepatitis B surface antigen result or a positive hepatitis C antibody test result at screening or within 3 months before first dose of study treatment are excluded, except for the following:\n\n    * Participants with positive anti-HBs antibody titer and confirmatory negative hepatitis B DNA polymerase chain reaction.\n    * Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if they have both completed curative therapy and have a hepatitis C viral load \\\u003C quantifiable limit.\n15. Any severe, acute, uncontrolled, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational or non-investigational products administration, or may interfere with the interpretation of study results, and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. Moreover, patients who, by virtue of an order issued by judicial or administrative authorities, are committed to an institution or those who cannot take part in clinical trials are excluded from this study.\n16. History of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent.\n17. Unable or unwilling to avoid medications, supplements (e.g., St. John's wort), or foods (e.g., grapefruit, pomegranate, pomelos, star fruit, Seville oranges and their juices) that are moderate\u002Fstrong inhibitors or inducers of CYP3A4 activity. Participation will be allowed if the medication, supplements, or foods are discontinued for at least 14 days prior to study entry and for the duration of the study.\n18. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.\n19. Receipt of live attenuated vaccination within 30 days prior to study entry. COVID-19 vaccines that do not contain live viruses are allowed (at least one week prior to study entry).","ALL","18 Years",{"count":20,"type":21},176,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Trial design:\n\nPhase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1\u002F2 mutation, with 2:1 randomization into Arm A (olaparib + elacestrant) or arm B (olaparib). Treatment in either arm will be given until disease progression, unacceptable toxicity, withdrawal of patient´s consent to study participation, or end of study.\n\nTrial population:\n\nPatients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1\u002F2 mutation, with an indication for standard-of-care PARP inhibitor therapy and planned treatment with olaparib, an ECOG performance status of 0-2 and life expectancy of \\> 6 months, with normal bone marrow and kidney functions and no active or newly diagnosed central nervous system (CNS) metastases or symptomatic metastatic visceral disease at risk of life-threatening complications.\n\nInterventions:\n\nPatients randomized to Arm A will receive 600 mg olaparib daily and 400 mg elacestrant daily, while patients randomized to Arm B will receive 600 mg olaparib daily. Blood tests (hematology, biochemistry) will be performed at the beginning of every cycle, and imaging for tumor assessment (chest and abdominopelvic imaging) as well as QoL assessments will be performed every three months and in case of suspicion of progression\u002Fend of study.",[27,28,29,30],"Hormone Receptor Positive HER-2 Negative Breast Cancer","Advanced or Metastatic Breast Cancer","BRCA1 Mutation","BRCA2 Mutation",[32,33,34,35,36],"Elacestrant","Olaparib","Breast cancer","Metastases","Palliative therapy","RECRUITING","2025-11-24",{"date":40,"type":41},"2025-12-01","ACTUAL",{"date":43,"type":41},"2024-12-13",{"date":45,"type":21},"2028-12-31",{"name":47,"class":48},"GBG Forschungs GmbH","OTHER",36,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100562791","phase-2-capivasertib-plus-fulvestrant-vs-fulvestrant-in-primary-high-risk-lobular-breast-cancer-100562791","NCT06607757","Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer","Phase II Neoadjuvant Study Evaluating Capivasertib Plus Fulvestrant vs Fulvestrant in Patients With Primary High-risk Lobular Breast Cancer- LOBSTER","Inclusion Criteria:\n\n1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and followup, and documented according to the local regulatory requirements.\n2. Postmenopausal women with age at diagnosis ≥ 18 years.\n\n   Postmenopausal status is defined as:\n   * Age ≥60 years\n   * Age \\\u003C60 years and amenorrhea for at least 12 continuous months with no identified cause other than menopause\n   * Bilateral oophorectomy Negative pregnancy test (urine or serum) within 14 days prior to randomization for all postmenopausal women 50 years of age or younger without bilateral oophorectomy\n3. Unilateral or bilateral primary untreated lobular invasive carcinoma of the breast. In case of bilateral breast cancer, both sides must be lobular; the lead tumor has to be defined by the investigator based on the inclusion criteria for the respective subtype and the risk status. Lobular histology has to be centrally confirmed.\n4. Willingness and ability to provide archived formalin fixed paraffin embedded (FFPE) tissue block from core biopsy before the start of neoadjuvant therapy.\n5. Centrally confirmed HER2-negative (IHC score 0-1+ or ISH negative according to ASCO\u002FCAP guideline) and HR-positive (≥10% positive stained cells) disease, assessed on the core of diagnostic biopsy. Ki67% \\>10% is required. In case of bilateral breast cancer, HER2-negative, HR-positive and lobular histology status has to be confirmed for both sides.\n6. Patients with invasive lobular breast cancer at high risk for recurrence defined as cT1c and clinical nodal involvement (cN+) or ≥ cT2 disease (irrespective of nodal involvement).\n7. No clinical evidence of distant metastases.\n8. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.\n9. Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer.\n10. The patient must be accessible for scheduled visits, treatment, and followup.\n11. Normal cardiac function must be confirmed according to local guidelines.\n12. Laboratory requirements:\n\n    Hematology\n    * Absolute neutrophil count (ANC) ≥1.5 x 109 \u002F L\n    * Platelets ≥100 x 109 \u002F L\n    * Hemoglobin ≥10 g\u002FdL (≥6.2 mmol\u002FL) Hepatic function\n    * Total bilirubin \\\u003C1.25x ULN\n    * AST and ALT \\\u003C=1.5x ULN\n    * Alkaline phosphatase \\\u003C=2.5x ULN Glucose Metabolism\n    * HbA1c \\\u003C8.0% (63.9 mmol\u002Fmol) Renal Function\n    * Creatinine \\\u003C1.25x ULN or creatinine clearance ≥50 ml\u002Fmin (if creatinine is above ULN according to Cockroft-Gault)\n13. Complete staging work-up prior to the initiation of neoadjuvant therapy as per standard recommendations.\n\nExclusion Criteria:\n\n1. Female patients of childbearing potential.\n2. Excisional biopsy or lumpectomy performed prior to study entry.\n3. Surgical axillary staging procedure including sentinel lymph node biopsy prior to randomization. Exceptions: FNA or core biopsy of an axillary lymph node.\n4. Any previous treatment including endocrine therapy, chemotherapy, radiotherapy or targeted therapy (including AKT inhibitor or PIK3 inhibitor) for the currently diagnosed breast cancer.\n5. Concurrent use of herbal or natural products intended as treatment or prophylaxis for any type of cancer.\n6. Known hypersensitivity reaction to one of the compounds or substances used in this protocol.\n7. Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort).\n8. Refractory nausea and vomiting, chronic gastrointestinal disease, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption, distribution, metabolism, or excretion of capivasertib.\n9. Any contraindication for fulvestrant.\n10. Patients with definitive clinical or radiologic evidence of stage IV cancer (metastatic disease) are not eligible.\n11. Patients with a history of any malignancy are ineligible with the following exceptions:\n\n    * Patient has been disease-free for at least 5 years and is at low risk for recurrence of that malignancy except for breast cancer.\n    * CIS of the cervix, basal cell and squamous cell carcinomas of the skin.\n12. History of type I or type II diabetes mellitus requiring insulin.\n13. Severe and relevant co-morbidity that would interact with the application of study drugs or the participation in the study, including cerebrovascular incident including transient ischemic attack, or symptomatic pulmonary embolism, active infection requiring intravenous anti-microbial treatment (antibiotics, anti-fungal, and anti-viral drugs) within 1 week of enrolment. Patients with confirmed Gilbert's syndrome may be included in the study.\n14. Known medically history of HIV infection, tuberculosis, or hepatitis B.\n15. History of and\u002For active cardiac disease that would preclude the use of study treatments. This includes but is not confined to any of the following cardiac criteria:\n\n    * Clinically significant cardiac dysfunction including heart failure (NYHA II-IV), active ventricular arrhythmias requiring medication or arrhythmias requiring a pacemaker, and history of a myocardial infarction within 6 months prior to randomization, angina pectoris, atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass graft, angioplasty, or vascular stent.\n    * Mean resting QT interval corrected by Fridericia's formula (QTcF) \\>470 msec obtained from 3 consecutive ECGs.\n    * Increased risk of QTc prolongation or risk of arrhythmic events such as heart failure, uncontrolled electrolyte disorders (e.g., hypocalcemia, hypokalemia, or hypomagnesemia), potential for torsades de pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval.\n16. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving therapy.\n17. History of significant neurological or psychiatric disorders including psychotic disorders, dementia, or seizures that would prohibit the understanding and giving of informed consent.\n18. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension or hypotension (BP \\\u003C50mmHg), significant aneurysm, renal transplant and active bleeding diseases).\n19. Major surgical procedure (excluding placement of vascular access) or significant traumatic injury within 4 weeks of the first dose of study intervention or an anticipated need for major surgery during the study.\n20. Participation in another clinical study with a study intervention or investigational medicinal device administered in the 4 weeks prior to first dose of study intervention or concurrent enrolment in another clinical study unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.","FEMALE",{"count":59,"type":21},120,[24],"This is a multicenter, prospective, open-label, randomized phase II study to evaluate the CCCA assessed by Ki67 drop below \\<2.7% from baseline to week 2 (window of opportunity) and to week 10 with capivasertib plus fulvestrant compared with fulvestrant alone as neoadjuvant treatment for primary high-risk lobular breast cancer patients.\n\n120 patients will be randomized to receive:\n\n\\- Capivasertib (400 mg po twice daily d1-4 followed by 3 days off) for 2 weeks followed by capivasertib (400 mg po twice daily d1-4 followed by 3 days off) and fulvestrant (500 mg i.m. q28d, with an additional 500 mg dose given two weeks after the initial dose) for additional 8 weeks (overall 4 administrations of fulvestrant)\n\nor\n\n\\- Fulvestrant (500mg i.m. q28d, with an additional 500 mg dose given two weeks after the core biopsy and the initial dose) for 10 weeks (overall 4 administrations) Treatment will be given until surgery\u002Fcore-biopsy, disease progression, unacceptable toxicity, or withdrawal of consent of the patient.\n\nAll patients will undergo core-biopsies, under treatment and after completing study therapy in order to assess Ki67%. Further treatment including surgery, (neo)adjuvant chemotherapy, radiotherapy, and (neo)adjuvant endocrine therapy will be administered at the discretion of the investigator and according to standard of care outside the clinical trial.",[63],"CCCA Assessed by Ki67 Drop Below \u003C2.7% From Baseline","2025-03-28",{"date":66,"type":41},"2025-04-02",{"date":68,"type":41},"2024-12-04",{"date":70,"type":21},"2026-08-31",{"name":47,"class":48},25,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100462773","phase-2-neoadjuvant-endocrine-therapy---the-pi3k-inhibitor-inavolisib-in-her2-hr-pik3ca-mutant-early-breast-cancer-100462773","NCT05306041","Neoadjuvant Endocrine Therapy +\u002F- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer","A Randomized, Open-label, Phase II Trial Comparing Neoadjuvant Endocrine Therapy in Combination with Trastuzumab, Pertuzumab +\u002F- the PI3K Inhibitor Inavolisib in Patients with HER2-positive, HR-positive, PIK3CA Mutant Early Breast Cancer-GeparPiPPa","GeparPiPPa","Inclusion Criteria\n\n1. Written informed consent for all study procedures according to local regulatory requirements prior to beginning specific protocol procedures.\n2. Untreated, unilateral primary carcinoma of the breast, confirmed histologically by core biopsy. Fine-needle aspiration alone is not sufficient. Incisional biopsy is not allowed.\n3. Tumor lesion in the breast must be measurable in two dimensions, preferably by sonography.\n4. Patients must be in the following stages of disease:\n\n   • cT1b - cT3 regardless of nodal status In patients with multifocal or multicentric breast cancer the largest lesion (target lesion) should be measured.\n5. HR+\u002FHER2+ disease with centrally confirmed ER-status, PR-status, HER2-status, PIK3CA mutation (tumor), Ki-67 value and TILs on core biopsy (target lesion). ER\u002FPgR positive and HER2-positive is defined according to current ASCO\u002FCAP guidelines. Formalin-fixed, paraffin-embedded (FFPE) breast tissue from core biopsy of target lesion has therefore to be sent to the GBG central pathology laboratory prior to randomization. In patients with multifocal or multicentric breast cancer, all non-target lesions must also be HR+\u002FHER2+, as confirmed by local testing.\n6. Age ≥ 18 years, female and male.\n7. ECOG Performance status 0-1.\n8. Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF or shortening fraction) within 3 months prior to randomization. Results for LVEF must be above 55%.\n9. Laboratory requirements:\n\n   Hematology\n   * Absolute neutrophil count (ANC) ≥ 1.5\u002F nL\n   * Platelets ≥ 100\u002F nL and\n   * Hemoglobin ≥ 10 g\u002FdL (≥ 6.2 mmol\u002FL) Hepatic function\n   * Total bilirubin \\\u003C ULN except for patients with Gilbert's syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN\n   * AST and ALT ≤ 1.5x ULN and\n   * Alkaline phosphatase ≤ 2.5x ULN\n\n   Glucose Metabolism:\n\n   • Glycosylated hemoglobin (HbA1c) \\\u003C 6.5%\n10. Negative pregnancy test (urine or serum) within 14 days prior to randomization for all women of childbearing potential. A woman is considered to be of childbearing potential if she is not hysterectomized or not postmenopausal.\n\n    Postmenopausal is defined as:\n    * ≥12 continuous months of amenorrhea with no identified cause other than menopause.\n    * Having undergone bilateral oophorectomy.\n11. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \\\u003C 1% per year during the treatment period and for least 7 months after the last dose of PH-FDC SC. Examples of non-hormonal contraceptive methods with a failure rate of \\\u003C 1% per year include: bilateral tubal ligation; male partner sterilization; intrauterine devices. For men: men must remain abstinent or use a condom with a spermicidal product during the treatment period and for 7 months after the last dose of PH-FDC therapy to avoid exposing the embryo. Men and women must refrain from donating sperm\u002Feggs during this same period.\n12. Staging work-up according to country guidelines prior to randomization including:\n\n    • Bilateral mammography and\u002For breast MRI in combination with a breast ultrasound. Exception: In men where MRI is medically not indicated breast ultrasound is sufficient.\n13. 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 HER2-negative breast cancer and\u002For HER2-positive, HR-negative breast cancer.\n2. Need of immediate neoadjuvant chemotherapy, e.g. inflammatory breast cancer.\n3. Patients with definitive clinical or radiologic evidence of Stage IV cancer.\n4. Excisional biopsy or lumpectomy and \u002For axillary lymph node dissection and\u002For sentinel lymph node biopsy performed prior to study entry (biopsy of clinical involved LN is warranted).\n5. Prior chemotherapy or endocrine therapy or radiation therapy prior to study entry with the following exceptions:\n\n   • If medically indicated, initiation of endocrine therapy up to 28 days prior to randomization and use of established fertility preservation methods in young patients interested in subsequent pregnancies is allowed.\n6. Patients with a history of breast cancer are ineligible with the following exceptions:\n\n   • Patient has been disease-free for more than 5 years and is at low risk for recurrence (at the investigator's discretion).\n7. Patients with a history of any treated malignancy are ineligible in case of high risk of recurrence (at the investigator's discretion) and\u002For ongoing oncological treatment. This also applies to patients who are at high risk that oncological treatment is indicated during study therapy.\n8. Patients with BMI\\>30 can be included at the investigator's discretion.\n9. Known hypersensitivity reaction to one of the compounds or substances, and\u002For murine proteins, and\u002For recombinant human hyaluronidase used in this protocol.\n10. Patients with an established diagnosis of diabetes mellitus type I or uncontrolled type II based on FPG and HbA1c.\n11. Patients who are immunocompromised as the result of HIV or receiving immunosuppressive therapies.\n12. Clinically significant and active liver disease, for example, sclerosing cholangitis, active viral hepatitis B or C infection, or autoimmune hepatic disorders.\n13. Patients with inflammatory bowel disease, such as Crohn's disease or ulcerative colitis, and active bowel inflammation (e.g., diverticulitis).\n14. Patients with any concurrent ocular or intraocular condition, excluding baseline cataracts, that would require medical or surgical intervention during the study period to prevent or treat vision loss. In addition, patients with active uveitis or vitritis, history of uveitis, or active infectious process in the eye.\n15. Patients with currently documented pneumonitis\u002Finterstitial lung disease.\n16. Known or suspected congestive heart failure (\\>NYHA I) and \u002F or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP \\>160 \u002F 90 mm Hg under treatment with three antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.\n17. Damaged skin at planned site of subcutaneous (SC) injections (thigh).\n18. Patients who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and\u002For have not normalized their INR.\n19. Concurrent treatment with: • Chronic corticosteroids unless initiated \\> 6 months prior to study entry and at low dose (10 mg or less methylprednisolone or equivalent).\n\n    * Sex hormones. Prior treatment must be stopped before randomization (GnRH a is allowed).\n    * Other experimental drugs or any other anti-cancer therapy.\n20. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.\n21. Female patients: pregnancy or lactation at the time of randomization.\n22. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.\n23. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results.",{"count":82,"type":21},170,[24],"Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive, HR-positive, PIK3CA mutant breast cancer.",[86],"HER2-positive Breast Cancer",[79,88],"German Breast Group","2025-02-13",{"date":91,"type":41},"2025-02-17",{"date":93,"type":41},"2023-01-02",{"date":95,"type":21},"2027-01",{"name":47,"class":48},29,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":108,"studyType":109,"phases":4,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100496082","long-term-safety-and-efficacy-of-gbg-study-participants-100496082","NCT05739591","Long-term Safety and Efficacy of GBG Study Participants","Registry for Long-term Follow-up of Safety and Efficacy Parameters of GBG Study Participants","ETERNITY","Inclusion criteria:\n\n* Participation and treatment in a GBG clinical trial for early breast cancer.\n* Prospective registration: Written informed consent according to local regulatory requirements prior to data and biomaterial collection.\n\nExclusion criteria:\n\n* Participation and treatment in a non-GBG clinical trial for early breast cancer.\n* Patients with advanced or metastatic breast cancer who have participated and received treatment in a GBG clinical trial.",{"count":107,"type":21},400,"10 Years","OBSERVATIONAL","The ETERNITY study is an international, multicenter, observational study that aims to follow up patients who have participated in a GBG trial for early breast cancer, even after the study has officially ended, in order to collect long-term data on survival, late or delayed adverse events, in addition to information related to pregnancy, fertility and other parameters impacting quality of life.",[112],"Breast Cancer",[114,115,116,117,118,119,88],"Registry","Breast cancer, early","Safety","Efficacy","Long-term follow-up","Long-term survival","2024-10-01",{"date":122,"type":41},"2024-10-02",{"date":124,"type":41},"2022-10-12",{"date":126,"type":21},"2030-05-19",{"name":47,"class":48},3,""]