Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-29 @ 4:03 PM
Study NCT ID:
NCT00003032
Status:
COMPLETED
Last Update Posted:
2020-04-01
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent 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': 'D000069585', 'term': 'Filgrastim'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D008942', 'term': 'Mitoxantrone'}, {'id': 'D013629', 'term': 'Tamoxifen'}], 'ancestors': [{'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': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'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': 'D000880', 'term': 'Anthraquinones'}, {'id': 'D000095322', 'term': 'Anthrones'}, {'id': 'D000873', 'term': 'Anthracenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013267', 'term': 'Stilbenes'}, {'id': 'D001597', 'term': 'Benzylidene Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 224}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2008-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-30', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-04-13', 'lastUpdatePostDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2004-04-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-04-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '18025439', 'type': 'RESULT', 'citation': "Crump M, Gluck S, Tu D, Stewart D, Levine M, Kirkbride P, Dancey J, O'Reilly S, Shore T, Couban S, Girouard C, Marlin S, Shepherd L, Pritchard KI. Randomized trial of high-dose chemotherapy with autologous peripheral-blood stem-cell support compared with standard-dose chemotherapy in women with metastatic breast cancer: NCIC MA.16. J Clin Oncol. 2008 Jan 1;26(1):37-43. doi: 10.1200/JCO.2007.11.8851. Epub 2007 Nov 19."}, {'type': 'RESULT', 'citation': 'Dancey J, Crump M, Gluck S, et al.: Quality of life (QOL) analysis of a randomized trial of high-dose chemotherapy (HDCT) with peripheral stem cell transplant (PSCT) versus standard chemotherapy (SCT) in women with metastatic breast cancer (MBC): National Cancer Institute of Canada Clinical Trials Group study (NCIC CTG) MA-16 . [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-3010, 749, 2003.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known whether standard therapy is more effective than high dose chemotherapy for breast cancer.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation with that of standard therapy in treating women with metastatic or recurrent breast cancer that has responded to previous chemotherapy.', 'detailedDescription': "OBJECTIVES: I. Compare the overall survival of women with metastatic breast cancer receiving either high dose chemotherapy and autologous peripheral blood stem cell therapy or standard therapy following response to anthracycline or taxane based chemotherapy. II. Evaluate the final response rates between the two treatment arms. III. Compare the two treatment arms with respect to toxic effects. IV. Assess health related quality of life in both groups of patients.\n\nOUTLINE: This is a multicenter, nonblinded, randomized study. Patients are stratified by type of induction chemotherapy, response status, presence of visceral disease, receptor status and tamoxifen therapy (ER negative; ER positive, no prior tamoxifen; ER positive, failed tamoxifen; receptor status unknown). A quality of life questionnaire is given to each patient before and during treatment, then every 3 months thereafter. Patients are assessed following 4 courses of induction chemotherapy. Those achieving complete remission, partial remission, or who have no evaluable disease are randomized to either treatment arm I or arm II. For treatment arm I, stem cells are mobilized by chemotherapy (courses 5 and 6) plus filgrastim (G-CSF) or with G-CSF alone. Following course 6, patients receive daily doses of IV cyclophosphamide, mitoxantrone, and carboplatin on days -6 to -3, followed by stem cell infusion on day 0 and G-CSF from day 5. In arm II, patients receive two further courses of standard induction chemotherapy, followed by maintenance chemotherapy at the discretion of the treating physician. All patients with positive receptor status or unknown receptor status who have not previously failed tamoxifen therapy, receive tamoxifen at the completion of post peripheral stem cell transplant (arm I) or induction chemotherapy (arm II). Following hematologic recovery from high dose chemotherapy patients in arm I with limited disease receive consolidated radiation and may also receive surgical treatment for limited disease. In arm II, patients who completed courses 5 and 6 of induction chemotherapy receive involved field radiation at the physician's discretion. Patients from arm II may also receive surgical treatment following protocol therapy at the physician's discretion. Patients are followed every 3 months until death.\n\nPROJECTED ACCRUAL: This study will accrue approximately 50 patients per year for a total of 192 patients in 3.8 years."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Metastatic disease and/or axillary node or chest wall recurrence following mastectomy diagnosed at least 3 months since prior adjuvant chemotherapy Radiologic scans required No inflammatory carcinoma of the breast without metastases (i.e. T4d M0) No previously untreated inflammatory carcinoma of the breast (T4d) No recurrent breast cancer diagnosed less than 3 months since prior adjuvant chemotherapy No history or evidence of CNS (brain or leptomeningeal) metastases Hormone receptor status: Not specified\n\nPATIENT CHARACTERISTICS: Age: 16 to 60 Sex: Female Performance status: ECOG 0-2 Menopausal status: Not specified Life expectancy: Not specified Hematopoietic: Hemoglobin at least 100 g/L Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: AST and/or ALT no greater than 3 times upper limit of normal OR AST and/or ALT no greater than 5 times upper limit of normal, if liver metastases Bilirubin no greater than 1.5 times upper limit of normal Renal: Serum creatinine no greater than 2 times upper limit of normal Cardiovascular: No history of congestive heart failure OR At least 1 year since prior myocardial infarction LVEF at least 45% or normal (ECHO or MUGA are acceptable) Other: No prior or concurrent malignancies allowed, except adequately treated squamous or basal cell carcinoma of the skin or in situ carcinoma of the cervix, or cancer treated more than 5 years ago and presumed cured Not HIV positive No clinical evidence of AIDS Not pregnant or nursing Effective contraception required of fertile patients No major medical illness precluding safe administration of planned treatment or required follow-up\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic response modifier therapy Chemotherapy: No prior chemotherapy for metastatic or recurrent breast cancer Induction chemotherapy required Endocrine therapy: Prior hormonal therapy allowed No concurrent hormonal therapy Radiotherapy: Concurrent radiotherapy allowed for pain control or to solitary bone or soft tissue sites Surgery: Prior oophorectomy allowed See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00003032', 'briefTitle': 'High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Women With Metastatic or Recurrent Breast Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'Canadian Cancer Trials Group'}, 'officialTitle': 'A Randomized Trial of High-Dose Chemotherapy and Autologous Stem Cell Therapy Versus Standard Therapy in Women With Metastatic Breast Cancer Who Have Responded to Anthracycline or Taxane-Based Induction Chemotherapy', 'orgStudyIdInfo': {'id': 'MA16'}, 'secondaryIdInfos': [{'id': 'CAN-NCIC-MA16'}, {'id': 'CDR0000065634', 'type': 'OTHER', 'domain': 'PDQ'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'filgrastim', 'type': 'BIOLOGICAL'}, {'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'cyclophosphamide', 'type': 'DRUG'}, {'name': 'mitoxantrone hydrochloride', 'type': 'DRUG'}, {'name': 'tamoxifen citrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Center - Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Cancer Agency', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'R3E 0V9', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'facility': 'CancerCare Manitoba', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}, {'zip': 'E1C 6ZB', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Moncton Hospital', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}, {'zip': 'E2L 4L2', 'city': 'Saint John', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Saint John Regional Hospital', 'geoPoint': {'lat': 45.27076, 'lon': -66.05616}}, {'zip': 'A1B 3V6', 'city': "St. John's", 'state': 'Newfoundland and Labrador', 'country': 'Canada', 'facility': 'Newfoundland Cancer Treatment and Research Foundation', 'geoPoint': {'lat': 47.56494, 'lon': -52.70931}}, {'zip': 'B3H 1V7', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Nova Scotia Cancer Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L6W 2Z8', 'city': 'Brampton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'William Osler Health Centre', 'geoPoint': {'lat': 43.68341, 'lon': -79.76633}}, {'zip': 'P3E 5J1', 'city': 'Greater Sudbury', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northeastern Ontario Regional Cancer Centre, Sudbury', 'geoPoint': {'lat': 46.49, 'lon': -80.99001}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-Hamilton Regional Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-London Regional Cancer Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'K1H 1C4', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Ottawa Regional Cancer Centre - General Campus', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'L2R 5K3', 'city': 'St. Catharines', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hotel Dieu Hospital - St. Catharines', 'geoPoint': {'lat': 43.17126, 'lon': -79.24267}}, {'zip': 'P7A 7T1', 'city': 'Thunder Bay', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Northwestern Ontario Regional Cancer Centre, Thunder Bay', 'geoPoint': {'lat': 48.38202, 'lon': -89.25018}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Sunnybrook Regional Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M9N 1N8', 'city': 'Weston', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Humber River Regional Hospital', 'geoPoint': {'lat': 43.70359, 'lon': -79.51513}}, {'zip': 'N8W 2X3', 'city': 'Windsor', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario - Windsor Regional Cancer Centre', 'geoPoint': {'lat': 42.30008, 'lon': -83.01654}}, {'zip': 'C1A 8T5', 'city': 'Charlottetown', 'state': 'Prince Edward Island', 'country': 'Canada', 'facility': 'Queen Elizabeth Hospital, PEI', 'geoPoint': {'lat': 46.23459, 'lon': -63.1256}}, {'zip': 'G6V 3Z1', 'city': 'Lévis', 'state': 'Quebec', 'country': 'Canada', 'facility': "L'Hotel Dieu de Levis", 'geoPoint': {'lat': 46.80326, 'lon': -71.17793}}, {'zip': 'H2L-4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': "Centre Hospitalier de l'Universite de Montreal", 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Department of Oncology', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2W 1T8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hotel Dieu de Montreal', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Quebec, Pavillion de Quebec', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Michael R. Crump, MD, FRCPC', 'role': 'STUDY_CHAIR', 'affiliation': 'Princess Margaret Hospital, Canada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NCIC Clinical Trials Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}