- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00003612
Combination Chemotherapy and Trastuzumab in Treating Women With Metastatic Breast Cancer
Randomized Phase II Trial of Paclitaxel, Carboplatin and rhuMAb Her-2 (Herceptin) as First-Line Chemotherapy in Patients With Metastatic Breast Cancer Who Overexpress Her-2
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel, carboplatin, and trastuzumab in treating women who have metastatic breast cancer that overexpresses HER2.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
- Compare the response rate associated with two different treatment schedules of paclitaxel, carboplatin, and trastuzumab (Herceptin) in women with overexpressed HER-2 growth factor receptor and metastatic breast cancer. (Schedule A closed to accrual effective 05/16/2003).
- Compare the time to progression and median survival in patients treated with these schedules.
- Compare the toxicity of these treatment schedules in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior adjuvant therapy (none vs less than 6 months vs at least 6 months), estrogen receptor (ER) status and progesterone receptor (PR) status at initial diagnosis (ER positive/PR positive or unknown vs ER positive/PR negative vs ER positive or unknown/PR negative), menopausal status (pre vs post), and performance status (0 or 1 vs 2). Patients are assigned to 1 of 2 treatment schedules.
- Schedule A: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes and then trastuzumab (Herceptin) IV over 90 minutes on day 1 of week 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30 minutes every 3 weeks until disease progression. (Schedule A closed to accrual effective 05/16/2003).
- Schedule B: Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 15 minutes on day 1 of weeks 1-3 and trastuzumab IV over 90 minutes immediately after carboplatin on day 1. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30 minutes every 3 weeks until disease progression.
Patients are followed every 3 months for 2 years and then every 6 months thereafter.
PROJECTED ACCRUAL: A total of 36-92 patients (18-46 per treatment schedule) will be accrued for this study within 7-18.5 months. (Schedule A closed to accrual effective 05/16/2003).
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Arizona
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Scottsdale, Arizona, Förenta staterna, 85259-5404
- CCOP - Scottsdale Oncology Program
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Florida
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Jacksonville, Florida, Förenta staterna, 32224
- Mayo Clinic
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Illinois
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Peoria, Illinois, Förenta staterna, 61602
- CCOP - Illinois Oncology Research Association
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Urbana, Illinois, Förenta staterna, 61801
- CCOP - Carle Cancer Center
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Urbana, Illinois, Förenta staterna, 61801
- Carle Cancer Center
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Iowa
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Cedar Rapids, Iowa, Förenta staterna, 52403-1206
- CCOP - Cedar Rapids Oncology Project
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Des Moines, Iowa, Förenta staterna, 50309-1016
- CCOP - Iowa Oncology Research Association
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Sioux City, Iowa, Förenta staterna, 51101-1733
- Siouxland Hematology-Oncology
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Kansas
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Wichita, Kansas, Förenta staterna, 67214-3882
- CCOP - Wichita
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Louisiana
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New Orleans, Louisiana, Förenta staterna, 70121
- CCOP - Ochsner
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Michigan
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Ann Arbor, Michigan, Förenta staterna, 48106
- CCOP - Michigan Cancer Research Consortium
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Minnesota
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Duluth, Minnesota, Förenta staterna, 55805
- CCOP - Duluth
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic Cancer Center
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Saint Cloud, Minnesota, Förenta staterna, 56303
- CentraCare Health Plaza
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Saint Louis Park, Minnesota, Förenta staterna, 55416
- CCOP - Metro-Minnesota
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Nebraska
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Omaha, Nebraska, Förenta staterna, 68106
- CCOP - Missouri Valley Cancer Consortium
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North Dakota
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Bismarck, North Dakota, Förenta staterna, 58501-5505
- Medcenter One Health System
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Fargo, North Dakota, Förenta staterna, 58122
- CCOP - Merit Care Hospital
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Grand Forks, North Dakota, Förenta staterna, 58201
- Altru Cancer Center
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Ohio
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Toledo, Ohio, Förenta staterna, 43623-3456
- CCOP - Toledo Community Hospital
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Pennsylvania
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Danville, Pennsylvania, Förenta staterna, 17822-2001
- CCOP - Geisinger Clinic and Medical Center
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South Dakota
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Rapid City, South Dakota, Förenta staterna, 57709
- Rapid City Regional Hospital
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Sioux Falls, South Dakota, Förenta staterna, 57104
- CCOP - Sioux Community Cancer Consortium
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Wisconsin
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Green Bay, Wisconsin, Förenta staterna, 54301
- CCOP - St. Vincent Hospital Cancer Center, Green Bay
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic adenocarcinoma of the breast
Strong overexpression of HER-2 by immunohistochemistry (3+)
- 0-2+ tumors allowed if demonstrate amplification by FISH
- Bidimensionally measurable disease
- Brain metastasis must not represent sole site of disease
- No untreated brain metastasis receiving radiotherapy
- Previously treated brain metastases in continued response to radiotherapy and/or surgery for at least 2 months allowed
Hormone receptor status:
- Positive or negative
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Sex:
- Female
Menopausal status:
- Not specified
Performance status:
- ECOG 0-2
Life expectancy:
- At least 3 months
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 mg/dL
- AST no greater than 3 times upper limit of normal (ULN) (5 times ULN if liver metastases present)
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No myocardial infarction within the past 6 months
- No congestive heart failure or unstable angina
- No clinically significant pericardial effusion or arrhythmia
Other:
- No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- No active uncontrolled infection
- No prior allergic reaction to Cremophor EL, anesthetics, or muscle relaxants
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent filgrastim (G-CSF)
Chemotherapy:
- Prior adjuvant chemotherapy allowed
- Prior taxane therapy allowed
- No prior cisplatin or carboplatin
- No prior chemotherapy for metastatic disease
Endocrine therapy:
- Not specified
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy to more than 25% of marrow
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- See Disease Characteristics
- At least 4 weeks since prior surgery and recovered
Other:
- At least 7 days since prior parenteral antibiotics
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Schedule A: paclitaxel + carboplatin + trastuzumab
Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes and then trastuzumab (Herceptin) IV over 90 minutes on day 1 of week 1. Treatment repeats every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30 minutes every 3 weeks until disease progression. Patients are followed every 3 months for 2 years and then every 6 months thereafter. |
|
Experimentell: Schedule B: paclitaxel + carboplatin + trastuzumab
Patients receive paclitaxel IV over 1 hour followed by carboplatin IV over 15 minutes on day 1 of weeks 1-3 and trastuzumab IV over 90 minutes immediately after carboplatin on day 1. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30 minutes every 3 weeks until disease progression. Patients are followed every 3 months for 2 years and then every 6 months thereafter. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
svarsfrekvens
Tidsram: Upp till 5 år
|
Upp till 5 år
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
tid till progression
Tidsram: Upp till 5 år
|
Upp till 5 år
|
median survival
Tidsram: Up to 5 years
|
Up to 5 years
|
Samarbetspartners och utredare
Samarbetspartners
Publikationer och användbara länkar
Allmänna publikationer
- Chumsri S, Sperinde J, Liu H, Gligorov J, Spano JP, Antoine M, Moreno Aspitia A, Tan W, Winslow J, Petropoulos CJ, Chenna A, Bates M, Weidler JM, Huang W, Dueck A, Perez EA. High p95HER2/HER2 Ratio Associated With Poor Outcome in Trastuzumab-Treated HER2-Positive Metastatic Breast Cancer NCCTG N0337 and NCCTG 98-32-52 (Alliance). Clin Cancer Res. 2018 Jul 1;24(13):3053-3058. doi: 10.1158/1078-0432.CCR-17-1864. Epub 2018 Mar 12.
- Perez EA, Suman VJ, Rowland KM, Ingle JN, Salim M, Loprinzi CL, Flynn PJ, Mailliard JA, Kardinal CG, Krook JE, Thrower AR, Visscher DW, Jenkins RB. Two concurrent phase II trials of paclitaxel/carboplatin/trastuzumab (weekly or every-3-week schedule) as first-line therapy in women with HER2-overexpressing metastatic breast cancer: NCCTG study 983252. Clin Breast Cancer. 2005 Dec;6(5):425-32. doi: 10.3816/CBC.2005.n.047.
- Perez EA, Rowland KM, Suman VJ, et al.: N98-32-52: efficacy and tolerability of two schedules of paclitaxel, carboplatin and trastuzumab in women with HER2 positive metastatic breast cancer: a North Central Cancer Treatment Group randomized phase II trial. [Abstract] Breast Cancer Res Treat 82 (Suppl 1): A-216, S47, 2003.
- Rowland KM, Suman VJ, Ingle JN, et al.: NCCTG 98-32-52: randomized phase II trial of weekly versus every 3-week administration of paclitaxel, carboplatin and trastuzumab in women with HER2 positive metastatic breast cancer (MBC). [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-31, 2003.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Hudsjukdomar
- Neoplasmer
- Neoplasmer efter plats
- Bröstsjukdomar
- Bröstneoplasmer
- Molekylära mekanismer för farmakologisk verkan
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Antineoplastiska medel, immunologiska
- Karboplatin
- Paklitaxel
- Trastuzumab
Andra studie-ID-nummer
- NCCTG-983252
- CDR0000066689 (Registeridentifierare: PDQ (Physician Data Query))
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