Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-28 @ 10:29 AM
Study NCT ID:
NCT05131893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-11-23
First Post:
2021-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Treatment of Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013629', 'term': 'Tamoxifen'}, {'id': 'D017273', 'term': 'Goserelin'}, {'id': 'D000077289', 'term': 'Letrozole'}, {'id': 'D015251', 'term': 'Epirubicin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D017239', 'term': 'Paclitaxel'}, {'id': 'D000068878', 'term': 'Trastuzumab'}, {'id': 'C485206', 'term': 'pertuzumab'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2031-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-20', 'studyFirstSubmitDate': '2021-07-30', 'studyFirstSubmitQcDate': '2021-11-20', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'dose density assessment', 'timeFrame': '3 year, maximum', 'description': 'actual dose / planned dose'}, {'measure': 'investigate the potential prognostic effect of neutrophil/lymphocyte ratio', 'timeFrame': '10 years', 'description': 'study of the role of neutrophil/lymphocyte ratio (NLR) at baseline, before the 3. cycle, and before surgery. NLR is measured from the qualitative blood count as the absolute neutrophil count divided by the absolute lymphocyte count'}, {'measure': 'investigate the potential prognostic effect of monocyte/lymphocyte ratio', 'timeFrame': '10 years', 'description': 'monocyte/lymphocyte ratio (MLR) at baseline, before the 3. cycle, and before surgery. MLR is measured from the qualitative blood count as the absolute monocyte count divided by the absolute lymphocyte count'}, {'measure': 'investigate potential prognostic factors, CRP', 'timeFrame': '10 years', 'description': 'C-reactive protein serum level befor start of chemotherapy'}, {'measure': 'investigate potential prognostic factors', 'timeFrame': '10 years', 'description': 'circulating free-DNA at baseline, before 3. cycle, before surgery'}], 'primaryOutcomes': [{'measure': 'pathological complete remission rate', 'timeFrame': '3 year, maximum', 'description': 'no invasive tumor in breast and axilla'}], 'secondaryOutcomes': [{'measure': 'invasive disease-free survival', 'timeFrame': '10 years', 'description': 'from the beginning of neoadjuvant therapy to the first appearance of invasive tumor or death'}, {'measure': 'European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)', 'timeFrame': '4 years', 'description': 'Global health status, functional and symptom scales survey using the EORTC QLQ-C30 questionnaire before cycle 1, before cycle 4, after the last neoadjuvant chemotherapy, and before surgery, 1 year after chemotherapy'}, {'measure': 'European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ BR45)', 'timeFrame': '4 years', 'description': 'Breast cancer-specific functional scales and symptom scales survey using the EORTC QLQ BR45 questionnaire before cycle 1, before cycle 4, after the last neoadjuvant chemotherapy, and before surgery, 1 year after chemotherapy'}, {'measure': 'evaluation of side effects', 'timeFrame': '10 years', 'description': 'to collect information all potential complaints and adverse event during and after treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neoadjuvant systemic therapy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'Observational investigation of participants who are given neoadjuvant treatment for invasive breast cancer. The scope of the study is to collect information on standardized treatment results, to explore the causes of dose modification and its effect on efficacy, to explore potential prognostic factors, and to explore the long-term side effects of different treatment modalities.', 'detailedDescription': 'The purpose of the study is based on the uniform application of international guidelines in Hungarian conditions. The standardized circumstances may lead to optimization of neoadjuvant therapy, it may facilitate subsequent data analysis, provide a basis for prospective clinical questions, and demonstrate improvement in pathologic complete remission (pCR) and overall survival (OS) compared to historical control. It may make possible to collect real-life data on each therapeutic option: efficacy, side effects, dose reduction, dose intensity, long-term consequences. The main scope is to collect prospective data to explore prognostic and predictive factors. The auxiliary aim is the assessment and comparison of quality of life during specific treatments and their side effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Breast cancer patients for whom neoadjuvant therapy is proposed by multidisciplinary team', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Participant over 18 years of age .\n2. Histologically confirmed (core biopsy) invasive breast tumor.\n3. Tumor extent for the indication:\n\n * regression must be achieved for radical surgical removal or\n * regression is required for breast-conserving surgery or\n * if hormone receptor (HR)-positive and Her2-: stage IIB (cT2N1 or cT3NO) - IIIC,\n * if HR-negative: stage IIA (cT2N0 or cT0-1N1) - IIIC Note: In the case of a locally advanced, irresectable case, if the possibility of radical surgery later is a realistic goal, the participant may be included in the study.\n4. Appropriate general condition: ECOG 0-1\n5. Proper organ function\n\n * Neutrophil count ≥ 1.5 G / l, platelet count ≥ 100 G / l, hemoglobin ≥ 10 g / dl\n * Alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is less than 1.5 times the upper limit of the normal range\n * bilirubin less than 1.5 times the upper limit of the normal range (except Gilbert's disease, where less than 3 times)\n * creatinine less than 1.5 times the upper limit of the normal range or estimated glomerular filtration rate (eGFR) higher than 60 ml / min\n\nExclusion Criteria:\n\n1. Proven or suspected distant metastasis.\n2. No staging studies have been performed: at least chest x-ray, abdominal ultrasound. It is preferred to perform CT from the chest, abdomen, pelvic regions and bone isotope, or PET / CT if possible in case of lymph node involvement.\n3. Known significant heart disease: major arrhythmia or significant conduction defect (grade 2 or more), infarction or unstable angina within 6 months, cardiac collapse without appropriate therapy, long QT syndrome, heart failure (≥New York Heart Association/NYHA II)\n4. Other severe acute or chronic conditions (organic or psychiatric illness, laboratory abnormality) that, in the opinion of the treating physician, result in an unacceptable increase in the risk of chemotherapy and are contraindicated in routine clinical practice.\n5. Pregnancy or if the participant does not agree to use an appropriate non-hormonal method of contraception."}, 'identificationModule': {'nctId': 'NCT05131893', 'briefTitle': 'Neoadjuvant Treatment of Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'National Institute of Oncology, Hungary'}, 'officialTitle': 'Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial', 'orgStudyIdInfo': {'id': 'PANONC-1 Version: 1.1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LuminalA', 'description': '1. tamoxifen (+ LHRH analogue for premenopausal participant)\n2. non-steroidal aromatase inhibitor (+ LHRH analogue for premenopausal participant)\n3. Non-steroidal aromatase inhibitor in non-resectable tumor (+ LHRH analogue in premenopausal participant) + CDK4 / 6 inhibitor', 'interventionNames': ['Drug: Tamoxifen', 'Drug: Goserelin', 'Drug: Letrozole 2.5Mg Tab']}, {'label': 'LuminalB (Her2 negative)', 'description': '1. 12 times weekly paclitaxel (80 mg / m˄2) followed by 4 times every 3 weeks epirubicin (E) (90-100 mg / m˄2) + cyclophosphamide (C) (600) (preferred)\n2. 4x 3 weekly E (90-100mg / m˄2) + C (600mg / m˄2), then\n\n 1. docetaxel (90-100 mg / m˄2) 4 times in every 3 weeks or\n 2. 12x weekly paclitaxel (80mg / m˄2)\n3. 4x every 2 weeks Epirubicin (E) (90-100mg / m˄2) + Cyclophosphamid (C) (600mg / m˄2), then\n\n 1. 4 times every 2 weeks with paclitaxel (175 mg / m˄2) or\n 2. 12x weekly paclitaxel (80mg / m˄2)\n4. TC: docetaxel (75 mg / m˄2) + cyclophosphamide (600 mg / m˄2) every 21 days with GCSF prevention (6 cycles)', 'interventionNames': ['Drug: Tamoxifen', 'Drug: Goserelin', 'Drug: Letrozole 2.5Mg Tab', 'Drug: Epirubicin', 'Drug: cyclophosphamide', 'Drug: Docetaxel', 'Drug: paclitaxel', 'Drug: trastuzumab']}, {'label': 'Her2 positive', 'description': '1. 4x 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then\n\n 1. 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly) or\n 2. 4x 3 weekly docetaxel (100mg / m˄2) + trastuzumab +/- pertuzumab\n2. Docetaxel (75 mg / m˄2) + carboplatin (AUC6) + trastuzumab +/- pertuzumab 6 times every 3 weeks c) E (90-100mg / m˄2) + C (600mg / m˄2) 4x every 2 weeks, then 12 times weekly paclitaxel + trastuzumab (every week or 3 weekly) +/- pertuzumab (3 weekly)', 'interventionNames': ['Drug: Tamoxifen', 'Drug: Goserelin', 'Drug: Letrozole 2.5Mg Tab', 'Drug: Epirubicin', 'Drug: cyclophosphamide', 'Drug: Docetaxel', 'Drug: paclitaxel', 'Drug: trastuzumab', 'Drug: pertuzumab']}, {'label': 'Triple-negative breast cancer', 'description': '1. Paclitaxel (80 mg / m˄2) +/- carboplatin (AUC2) 12 times weekly, then E (90-100 mg / m˄2) + C (600 mg / m˄2) 4 times three weekly (preferred)\n2. 4x every 3 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then\n\n 1. 4x docetaxel (90-100mg / m˄2) or\n 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2 )\n3. 4x every 2 weeks E (90-100mg / m˄2) + C (600mg / m˄2), then\n\n 1. 4 times every 2 weeks paclitaxel (175 mg / m˄2) or\n 2. 12x weekly paclitaxel (80mg / m˄2) +/- carboplatin (AUC2)', 'interventionNames': ['Drug: Epirubicin', 'Drug: cyclophosphamide', 'Drug: Docetaxel', 'Drug: paclitaxel', 'Drug: Capecitabine']}], 'interventions': [{'name': 'Tamoxifen', 'type': 'DRUG', 'description': 'endocrine therapy', 'armGroupLabels': ['Her2 positive', 'LuminalA', 'LuminalB (Her2 negative)']}, {'name': 'Goserelin', 'type': 'DRUG', 'description': 'endocrine therapy', 'armGroupLabels': ['Her2 positive', 'LuminalA', 'LuminalB (Her2 negative)']}, {'name': 'Letrozole 2.5Mg Tab', 'type': 'DRUG', 'otherNames': ['letrozole'], 'description': 'endocrine therapy', 'armGroupLabels': ['Her2 positive', 'LuminalA', 'LuminalB (Her2 negative)']}, {'name': 'Epirubicin', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Her2 positive', 'LuminalB (Her2 negative)', 'Triple-negative breast cancer']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Her2 positive', 'LuminalB (Her2 negative)', 'Triple-negative breast cancer']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Her2 positive', 'LuminalB (Her2 negative)', 'Triple-negative breast cancer']}, {'name': 'paclitaxel', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Her2 positive', 'LuminalB (Her2 negative)', 'Triple-negative breast cancer']}, {'name': 'trastuzumab', 'type': 'DRUG', 'description': 'biological treatment', 'armGroupLabels': ['Her2 positive', 'LuminalB (Her2 negative)']}, {'name': 'pertuzumab', 'type': 'DRUG', 'description': 'biological treatment', 'armGroupLabels': ['Her2 positive']}, {'name': 'Capecitabine', 'type': 'DRUG', 'description': 'chemotherapy', 'armGroupLabels': ['Triple-negative breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1122', 'city': 'Budapest', 'country': 'Hungary', 'contacts': [{'name': 'Gabor Rubovszky, Ph D', 'role': 'CONTACT', 'email': 'garub@oncol.hu', 'phone': '+3612248600', 'phoneExt': '3442'}, {'name': 'Balazs Madaras', 'role': 'CONTACT', 'email': 'madarasb@gmail.com', 'phone': '+3612248600'}], 'facility': 'National Institute of Oncolgy', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}], 'centralContacts': [{'name': 'gabor Rubovszky', 'role': 'CONTACT', 'email': 'garub@oncol.hu', 'phone': '+3612248600', 'phoneExt': '3442'}, {'name': 'Balazs Madaras', 'role': 'CONTACT', 'email': 'madarasb@oncol.hu', 'phone': '+3612248600'}], 'overallOfficials': [{'name': 'Gabor Rubovszky', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NIO Hungary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The individual participant data are not planned to be shared with other researchers but will be available upon request except personal data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Oncology, Hungary', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Surgical Oncology', 'investigatorFullName': 'Dr. Zoltan Matrai', 'investigatorAffiliation': 'National Institute of Oncology, Hungary'}}}}