Ignite Creation Date:
2025-12-24 @ 2:00 PM
Ignite Modification Date:
2025-12-26 @ 1:09 PM
Study NCT ID:
NCT00017095
Status:
COMPLETED
Last Update Posted:
2013-10-24
First Post:
2001-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer
Sponsor:
Organization:
Raw JSON
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[{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}, {'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D004317', 'term': 'Doxorubicin'}, {'id': 'D003630', 'term': 'Daunorubicin'}, {'id': 'D018943', 'term': 'Anthracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D046208', 'term': 'Microchip Analytical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1856}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-23', 'studyFirstSubmitDate': '2001-06-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'from randomization till first evidence of progression'}], 'secondaryOutcomes': [{'measure': 'Distant metastasis-free survival', 'timeFrame': 'randomization till first evidence recurrence'}, {'measure': 'Overall survival', 'timeFrame': 'randomization till death'}, {'measure': 'Clinical and pathological responses', 'timeFrame': 'after 3rd and 6d cycle of chemotherapy'}, {'measure': 'Clinical response according to RECIST criteria without pathologic response', 'timeFrame': 'after 3rd and 6d cycle of chemotherapy'}, {'measure': 'Toxicity according to CTC v2.0', 'timeFrame': 'from randomization'}, {'measure': 'Agreement between p53 assessment by IHC method and functional test in yeast by analyzing the correlation between p52 and tumor status after 3 and 6 cycles of chemotherapy', 'timeFrame': 'after 3 and 6 cycles of chemotherapy'}, {'measure': 'Tumor assessment using cDNA microarray technology', 'timeFrame': 'end of treatment'}]}, 'conditionsModule': {'keywords': ['stage II breast cancer', 'stage IIIA breast cancer', 'stage IIIB breast cancer', 'stage IIIC breast cancer', 'inflammatory breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '21277543', 'type': 'BACKGROUND', 'citation': 'Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, Andre S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Retraction--Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2011 Feb;12(2):116. doi: 10.1016/S1470-2045(11)70011-0. No abstract available.'}, {'pmid': '21422418', 'type': 'BACKGROUND', 'citation': "Desmedt C, Di Leo A, de Azambuja E, Larsimont D, Haibe-Kains B, Selleslags J, Delaloge S, Duhem C, Kains JP, Carly B, Maerevoet M, Vindevoghel A, Rouas G, Lallemand F, Durbecq V, Cardoso F, Salgado R, Rovere R, Bontempi G, Michiels S, Buyse M, Nogaret JM, Qi Y, Symmans F, Pusztai L, D'Hondt V, Piccart-Gebhart M, Sotiriou C. Multifactorial approach to predicting resistance to anthracyclines. J Clin Oncol. 2011 Apr 20;29(12):1578-86. doi: 10.1200/JCO.2010.31.2231. Epub 2011 Mar 21."}, {'pmid': '21570352', 'type': 'RESULT', 'citation': 'Bonnefoi H, Piccart M, Bogaerts J, Mauriac L, Fumoleau P, Brain E, Petit T, Rouanet P, Jassem J, Blot E, Zaman K, Cufer T, Lortholary A, Lidbrink E, Andre S, Litiere S, Lago LD, Becette V, Cameron DA, Bergh J, Iggo R; EORTC 10994/BIG 1-00 Study Investigators. TP53 status for prediction of sensitivity to taxane versus non-taxane neoadjuvant chemotherapy in breast cancer (EORTC 10994/BIG 1-00): a randomised phase 3 trial. Lancet Oncol. 2011 Jun;12(6):527-39. doi: 10.1016/S1470-2045(11)70094-8. Epub 2011 May 11.'}, {'type': 'RESULT', 'citation': 'Bonnefoi HR, Bogaerts J, Piccart M, et al.: Phase III trial (EORTC 10994/BIG 00-01) assessing the value of p53 using a functional assay to predict sensitivity to a taxane versus nontaxane primary chemotherapy in breast cancer: final analysis. [Abstract] J Clin Oncol 28 (Suppl 18): A-LBA503, 2010.'}, {'pmid': '20667781', 'type': 'RESULT', 'citation': 'Collingridge D. Expression of concern--validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2010 Sep;11(9):813-4. doi: 10.1016/S1470-2045(10)70185-6. Epub 2010 Jul 26. No abstract available.'}, {'type': 'RESULT', 'citation': 'Bonnefoi H, Zimmer AS, Piccart M, et al.: P53 functional assay in yeast: evaluation in 1856 patients in a large prospective clinical trial: EORTC 10994/BIG 00-01. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-1067, 2008.'}, {'pmid': '18024211', 'type': 'RESULT', 'citation': 'Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, Andre S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Validation of gene signatures that predict the response of breast cancer to neoadjuvant chemotherapy: a substudy of the EORTC 10994/BIG 00-01 clinical trial. Lancet Oncol. 2007 Dec;8(12):1071-1078. doi: 10.1016/S1470-2045(07)70345-5. Epub 2007 Nov 19.', 'retractions': [{'pmid': '21277543', 'source': 'Bonnefoi H, Potti A, Delorenzi M, Mauriac L, Campone M, Tubiana-Hulin M, Petit T, Rouanet P, Jassem J, Blot E, Becette V, Farmer P, André S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Lancet Oncol. 2011 Feb;12(2):116'}]}, {'type': 'RESULT', 'citation': 'Karina M, Bogaerts J, Piccart M, et al.: Preliminary safety data of the EORTC 10994/BIG 00-01 neoadjuvant trial comparing 3 cycles of docetaxel followed by 3 cycles of epirubicin-docetaxel versus 6 cycles of FEC 100 in patients with locally advanced/inflammatory or large operable breast cancer. [Abstract] Breast Cancer Res Treat 100 (Suppl 1): A-3067, S146-7, 2006.'}, {'type': 'RESULT', 'citation': 'Bonnefoi H, Farmer P, Delorenzi M, et al.: Is there a regimen-specific gene signature predicting for pathological complete response after neoadjuvant chemotherapy in hormone-negative breast cancer patients? A microarray substudy of 101 patients included in EORTC 10994/BIG 00-01 trial. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1040, 2005.'}, {'type': 'RESULT', 'citation': 'Farmer P, Iggo R, Becette V, et al.: High quality gene expression microarray data from a multicentre prospective trial: results of the first microarray analysis in the EORTC 10994/ BIG 00-01 study. [Abstract] Eur J Cancer 2 (Suppl 3): A-155, 99, 2004.'}, {'pmid': '34480095', 'type': 'DERIVED', 'citation': 'Chatzipli A, Bonnefoi H, MacGrogan G, Sentis J, Cameron D, Poncet C; EORTC 10994/BIG 1-00 Consortium; Iggo R. Patterns of genomic change in residual disease after neoadjuvant chemotherapy for estrogen receptor-positive and HER2-negative breast cancer. Br J Cancer. 2021 Nov;125(10):1356-1364. doi: 10.1038/s41416-021-01526-3. Epub 2021 Sep 3.'}, {'pmid': '24618153', 'type': 'DERIVED', 'citation': 'Bonnefoi H, Litiere S, Piccart M, MacGrogan G, Fumoleau P, Brain E, Petit T, Rouanet P, Jassem J, Moldovan C, Bodmer A, Zaman K, Cufer T, Campone M, Luporsi E, Malmstrom P, Werutsky G, Bogaerts J, Bergh J, Cameron DA; EORTC 10994/BIG 1-00 Study investigators. Pathological complete response after neoadjuvant chemotherapy is an independent predictive factor irrespective of simplified breast cancer intrinsic subtypes: a landmark and two-step approach analyses from the EORTC 10994/BIG 1-00 phase III trial. Ann Oncol. 2014 Jun;25(6):1128-36. doi: 10.1093/annonc/mdu118. Epub 2014 Mar 11.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Currently patients with breast cancer are treated with one of several very similar combinations of drugs. Analysis of biomarkers in tumor tissue may help doctors predict how well patients with breast cancer will respond to treatment and help doctors choose the best drug regimen to treat each patient.\n\nPURPOSE: This randomized phase III trial is studying giving different regimens of chemotherapy and comparing how well they work in treating women with large operable or locally advanced or inflammatory breast cancer. This study is also looking at whether analyzing a specific biomarker (p53) in tumor tissue may help doctors predict how well patients will respond to treatment and help doctors choose the best drug to treat each patient.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare neoadjuvant fluorouracil, epirubicin, and cyclophosphamide vs docetaxel and epirubicin followed by radiotherapy and surgery in women with locally advanced, inflammatory, or large operable breast cancer.\n* Assess overall differences between the two arms.\n* Assess interaction between p53 status and outcomes in each arm.\n* Compare the progression-free survival of patients treated with these regimens.\n\nSecondary\n\n* Compare the distant metastasis-free survival and survival of patients treated with these regimens.\n* Compare the clinical and pathological responses to these regimens in these patients.\n* Compare the toxicity of these regimens in these patients.\n\nTranslational\n\n* Determine the p53 status in order to study the treatment effect in each of the p53 subgroups and test the interaction between treatment and p53 status.\n* Assess the level of agreement between p53 assessment by IHC method and functional test in yeast.\n* Evaluate the prognostic and predictive value of "high risk" p53 mutations.\n* Perform a survival analysis according to gene clusters defined with the use of microarrays.\n\nOUTLINE: This is a randomized, multicenter study. Patients are stratified according to stage of disease (large T2-3 vs locally advanced or inflammatory), p53 status (negative vs positive vs unknown), and participating center. Patients are randomized to 1 of 2 chemotherapy treatment arms.\n\n* Arm I (non-taxane arm): Patients receive 1 of 3 chemotherapy regimens comprising fluorouracil, epirubicin, and cyclophosphamide (FEC) (according to participating institution).\n\n * FEC 100: Patients receive fluorouracil IV over 15 minutes, epirubicin IV over 1 hour, and cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.\n * Canadian FEC: Patients receive oral cyclophosphamide on days 1-14 and epirubicin IV and fluorouracil IV on days 1 and 8. If oral medications are not tolerated, patients may switch to cyclophosphamide IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.\n * Tailored FEC: Patients receive fluorouracil IV over 15 minutes, epirubicin IV over 1 hour, and cyclophosphamide IV over 1-2 hours on day 1. Patients also receive filgrastim (G-CSF) subcutaneously on days 2-15 or until blood counts recover. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.\n* Arm II (taxane arm): Patients receive docetaxel IV over 1 hour on days 1, 22, and 43 followed by epirubicin IV over 15 minutes and docetaxel IV over 1 hour on days 64, 85, and 106 in the absence of disease progression or unacceptable toxicity.\n\nFollowing chemotherapy, patients may undergo loco-regional therapy comprising radiotherapy with or without breast conservation surgery or mastectomy. Patients with estrogen- and/or progesterone-receptor-positive disease also receive tamoxifen or an aromatase inhibitor for 5 years.\n\nTwo tumor samples (incisional or tricut biopsies) are taken before chemotherapy. Samples are analyzed by IHC, a functional test in yeast, and microarray analysis.\n\nPatients are followed every 3 months for 1 year, every 4 months for 1.5 years, and then every 6 months thereafter.\n\nPROJECTED ACCRUAL: A total of 1,850 patients will be accrued for this study within 5.5 years.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n\n * Locally advanced or inflammatory disease\n\n * T4a-d, any N, M0 OR\n * Any T, N2 or N3, M0\n * Large operable T2 or T3 tumors\n* No bilateral breast cancer\n* Frozen tumor sample available\n\n * 1 incisional biopsy OR\n * 2 trucut biopsies from a 14G needle\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 70 and under\n\nSex:\n\n* Female\n\nMenopausal status:\n\n* Not specified\n\nPerformance status:\n\n* WHO 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Neutrophil count greater than 1,500/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 1.2 mg/dL\n* SGOT less than 60 IU/L\n\nRenal:\n\n* Creatinine less than 1.35 mg/dL\n\nCardiovascular:\n\n* LVEF normal by echocardiography or MUGA\n\nOther:\n\n* No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix\n* No serious uncontrolled medical condition\n* No uncontrolled psychiatric or addictive disorders\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* No prior chemotherapy\n\nEndocrine therapy:\n\n* Not specified\n\nRadiotherapy:\n\n* No prior radiotherapy\n\nSurgery:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00017095', 'briefTitle': 'Biomarker (p53 Gene) Analysis and Combination Chemotherapy Followed by Radiation Therapy and Surgery in Treating Women With Large Operable or Locally Advanced or Inflammatory Breast Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'First Prospective Intergroup Translational Research Trial Assessing the Potential Predictive Value of p53 Using a Functional Assay in Yeast in Patients With Locally Advanced/Inflammatory or Large Operable Breast Cancer Prospectively Randomised to a Taxane Versus a Non Taxane Regimen', 'orgStudyIdInfo': {'id': 'EORTC-10994-p53'}, 'secondaryIdInfos': [{'id': 'EORTC-10994'}, {'id': 'ACCOG-EORTC-10994'}, {'id': 'SAKK-EORTC-10994'}, {'id': 'SBGC-EORTC-10994'}, {'id': 'BIG-1-00'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'non taxane based chemotherapy', 'description': 'either FEC 100 or Canadian CEF or Tailored FEC for 6 cycles', 'interventionNames': ['Biological: filgrastim', 'Drug: cyclophosphamide', 'Drug: epirubicin hydrochloride', 'Drug: fluorouracil', 'Genetic: microarray analysis', 'Other: immunohistochemistry staining method', 'Other: laboratory biomarker analysis', 'Procedure: biopsy', 'Procedure: conventional surgery', 'Procedure: neoadjuvant therapy', 'Radiation: radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'taxane based chemotherapy', 'description': 'Docetaxel for 3 cycles followed by Epirubicin/Docetaxel for 3 cycles', 'interventionNames': ['Drug: docetaxel', 'Drug: epirubicin hydrochloride', 'Genetic: microarray analysis', 'Other: immunohistochemistry staining method', 'Other: laboratory biomarker analysis', 'Procedure: biopsy', 'Procedure: conventional surgery', 'Procedure: neoadjuvant therapy', 'Radiation: radiation therapy']}], 'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL', 'armGroupLabels': ['non taxane based chemotherapy']}, {'name': 'cyclophosphamide', 'type': 'DRUG', 'armGroupLabels': ['non taxane based chemotherapy']}, {'name': 'docetaxel', 'type': 'DRUG', 'armGroupLabels': ['taxane based chemotherapy']}, {'name': 'epirubicin hydrochloride', 'type': 'DRUG', 'armGroupLabels': ['non taxane based chemotherapy', 'taxane based chemotherapy']}, {'name': 'fluorouracil', 'type': 'DRUG', 'armGroupLabels': ['non taxane based chemotherapy']}, {'name': 'microarray analysis', 'type': 'GENETIC', 'armGroupLabels': ['non taxane based chemotherapy', 'taxane based chemotherapy']}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER', 'armGroupLabels': ['non taxane based chemotherapy', 'taxane based chemotherapy']}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'armGroupLabels': ['non taxane based chemotherapy', 'taxane based chemotherapy']}, {'name': 'biopsy', 'type': 'PROCEDURE', 'armGroupLabels': ['non taxane based chemotherapy', 'taxane based chemotherapy']}, {'name': 'conventional surgery', 'type': 'PROCEDURE', 'armGroupLabels': ['non taxane based chemotherapy', 'taxane based chemotherapy']}, {'name': 'neoadjuvant therapy', 'type': 'PROCEDURE', 'armGroupLabels': ['non taxane based chemotherapy', 'taxane based chemotherapy']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'armGroupLabels': ['non taxane based chemotherapy', 'taxane based chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Institut Jules Bordet', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'B-4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'CHU Liege - 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