Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2026-01-10 @ 4:27 AM
Study NCT ID:
NCT00321633
Status:
COMPLETED
Last Update Posted:
2013-08-26
First Post:
2006-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D061325', 'term': 'Hereditary Breast and Ovarian Cancer Syndrome'}], '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'}, {'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D000077143', 'term': 'Docetaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'lastUpdateSubmitDate': '2013-08-23', 'studyFirstSubmitDate': '2006-05-02', 'studyFirstSubmitQcDate': '2006-05-02', 'lastUpdatePostDateStruct': {'date': '2013-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response and toxicity'}], 'secondaryOutcomes': [{'measure': 'Time to progression'}]}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer', 'hereditary breast/ovarian cancer (BRCA1, BRCA2)', 'BRCA1 mutation carrier', 'BRCA2 mutation carrier'], 'conditions': ['brca1 Mutation Carrier', 'brca2 Mutation Carrier', 'Breast Cancer', 'Hereditary Breast/Ovarian Cancer (brca1, brca2)']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether carboplatin is more effective than docetaxel in treating patients with metastatic genetic breast cancer.\n\nPURPOSE: This randomized phase II trial is studying carboplatin to see how well it works compared to docetaxel in treating women with metastatic genetic breast cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare the safety and effectiveness of carboplatin vs docetaxel in women with metastatic breast cancer and the BRCA1 or BRCA2 gene mutation.\n\nSecondary\n\n* Compare time to disease progression in patients treated with these regimens.\n* Compare progression-free survival of patients treated with carboplatin vs docetaxel.\n\nOUTLINE: This is a randomized, open-label, multicenter, pilot study. Patients are stratified according to gene mutation (BRCA1 vs BRCA2), prior adjuvant taxane chemotherapy (yes vs no), liver or lung metastasis affecting the parenchyma (yes vs no), Jewish ancestry by parent or grandparent (yes vs no), and first-line treatment vs second-line treatment. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive carboplatin IV over 1 hour on day 1.\n* Arm 2: Patients receive docetaxel IV over 1 hour on day 1. In both arms, treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 3 or 6 courses of treatment may crossover to the alternative treatment arm. If progression is present after 3 courses in the crossover arm, patients may receive further treatment at the discretion of their oncologist. Patients responding to and tolerating treatment well, may be given 2 further courses in accordance with local center policy, although this is not encouraged.\n\nPatients with HER2-positive disease may receive trastuzumab (Herceptin®) IV once every 7 or 21 days.\n\nAfter completion of study treatment, patients are followed periodically for survival.\n\nPeer Reviewed and Funded or Endorsed by Cancer Research UK\n\nPROJECTED ACCRUAL: A total of 148 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed breast cancer\n\n * BRCA1 or BRCA2 mutation carrier\n * Metastatic disease\n* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan\n* Stable, treated brain metastases allowed provided other sites of measurable disease are present\n* Patients with bone metastases who are currently receiving bisphosphonates for palliation are eligible provided other sites of measurable disease are present\n* Patients who have not received anthracycline-based chemotherapy in the adjuvant setting may receive a non-taxane, anthracycline regimen as the first-line metastatic treatment and enter the trial at confirmed progression (second-line)\n* No bone-limited disease\n* No disease suitable for endocrine therapy alone\n* Hormone receptor status not specified\n\nPATIENT CHARACTERISTICS:\n\n* Menopausal status not specified\n* Sex: female\n* WHO performance status 0-2\n* Life expectancy ≥ 3 months\n* AST and/or ALT ≤ 5 times upper limit of normal (ULN) (≤ 3 if alkaline phosphatase \\> 5 times ULN)\n* Glomerular filtration rate ≥ 30 mL/min\n* Normal urea and creatinine\n* Normal hematological and biochemical studies\n* Normal bilirubin\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for 6 months after completion of study treatment\n* Negative pregnancy test\n* No known allergy to platinum compounds or mannitol\n* No known sensitivity to taxanes\n* No other malignancy within the past 10 years except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin\n* No sensory or motor neuropathy \\> grade 1\n* No other serious uncontrolled medical conditions or concurrent medical illness that would preclude study compliance\n* No contraindication to chemotherapy\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 12 months since prior taxane therapy\n* No prior chemotherapy with a platinum drug, unless treatment was for a non-breast cancer-related disease more than 10 years ago'}, 'identificationModule': {'nctId': 'NCT00321633', 'briefTitle': 'Carboplatin or Docetaxel in Treating Women With Metastatic Genetic Breast Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomized Phase II Pilot Trial of Carboplatin Compared to Docetaxel for Patients With Metastatic Genetic Breast Cancer [BRCA Trial]', 'orgStudyIdInfo': {'id': 'CDR0000467994'}, 'secondaryIdInfos': [{'id': 'CRUK-BRCA-TRIAL'}, {'id': 'EUDRACT-2004-001496-20'}, {'id': 'EU-20603'}, {'id': 'ISRCTN43372330'}, {'id': 'BBC-CRUK-BRCA-TRIAL'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'carboplatin', 'type': 'DRUG'}, {'name': 'docetaxel', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3050', 'city': 'Parkville', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Royal Melbourne Hospital', 'geoPoint': {'lat': -37.78333, 'lon': 144.95}}, {'zip': '84101', 'city': 'Beersheba', 'country': 'Israel', 'facility': 'Soroka University Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Nahariya', 'country': 'Israel', 'facility': 'Naharia Hospital', 'geoPoint': {'lat': 33.00892, 'lon': 35.09814}}, {'zip': '52621', 'city': 'Tel Litwinsky', 'country': 'Israel', 'facility': 'Chaim Sheba Medical Center', 'geoPoint': {'lat': 32.05096, 'lon': 34.84588}}, {'zip': '1099-023 Codex', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, SA', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': "Vall d'Hebron University Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': 'SE-22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}, {'zip': 'CB2 2QQ', 'city': 'Cambridge', 'state': 'England', 'country': 'United Kingdom', 'facility': "Addenbrooke's Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'zip': 'EX2 5DW', 'city': 'Exeter', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Devon and Exeter Hospital', 'geoPoint': {'lat': 50.7236, 'lon': -3.52751}}, {'zip': 'NW3 2QG', 'city': 'Hampstead, London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'UCL Cancer Institute'}, {'zip': 'LS16 6QB', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Cookridge Hospital', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'England', 'country': 'United Kingdom', 'facility': "Leeds Cancer Centre at St. James's University Hospital", 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'SE1 9RT', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': "Guy's Hospital", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SW3 6JJ', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Royal Marsden - Surrey', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Christie Hospital', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'zip': 'CH63 4JY', 'city': 'Merseyside', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Clatterbridge Centre for Oncology'}, {'zip': 'NR31 6LA', 'city': 'Norfolk', 'state': 'England', 'country': 'United Kingdom', 'facility': 'James Paget Hospital'}, {'zip': 'HA6 2RN', 'city': 'Northwood', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Mount Vernon Cancer Centre at Mount Vernon Hospital', 'geoPoint': {'lat': 51.61162, 'lon': -0.42454}}, {'zip': 'NR4 7UY', 'city': 'Norwich', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Norfolk and Norwich University Hospital', 'geoPoint': {'lat': 52.62783, 'lon': 1.29834}}, {'zip': 'BH15 2JB', 'city': 'Poole Dorset', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Dorset Cancer Centre'}, {'zip': 'PO3 6AD', 'city': 'Portsmouth Hants', 'state': 'England', 'country': 'United Kingdom', 'facility': "Portsmouth Oncology Centre at Saint Mary's Hospital"}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Southampton General Hospital', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'TQ2 7AA', 'city': 'Torquay', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Torbay Hospital', 'geoPoint': {'lat': 50.46198, 'lon': -3.52522}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Edinburgh Cancer Centre at Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'CF14 2TL', 'city': 'Cardiff', 'state': 'Wales', 'country': 'United Kingdom', 'facility': 'Velindre Cancer Center at Velindre Hospital', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}], 'overallOfficials': [{'name': 'Andrew Tutt, MD, PhD, FRCR, MBBS, MRCP', 'role': 'STUDY_CHAIR', 'affiliation': "Guy's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College London Hospitals', 'class': 'OTHER'}}}}