- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT00603408
Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer
Effect of Neoadjuvant Cisplatin Based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
After Diagnosis: Clinical Stage IIB, III Breast Cancer, Triple Negative
Week 0: Port-A-Cath placement Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration Sentinel Lymph node biopsy, if axillary US negative
Week 1: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 1) Days 2-5: Radiation Therapy
Week 2: Radiation Day 1-5: Radiation Therapy
Week 3: Radiation Days 1-5: Radiation Therapy
Week 4: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m^2 (cycle 2) Days 2-5: Radiation Therapy
Week 5: Radiation Days 1-5: Radiation Therapy
Week 6: Radiation Days 1-5: Radiation Therapy
Week 7: Chemo Day 1: Cisplatin 75mg/m^2 (cycle 3)
Week 10: Chemo Day 1:Cisplatin 75mg/m^2 (cycle 4)
Week 13: Surgery Mastectomy with/without axillary lymph node dissection Tumor biopsy (Core and FNA) Blood collection Bone marrow aspiration
Week 15 - 21: Recommended (physician discretion) Adjuvant Chemo Dose dense Doxorubicin: 60mg/m^2 & Cyclophosphamide: 600mg/m^2, every 2 weeks for 4 cycles
Week 21 - 29: Recommended (physician discretion) Adjuvant Chemo Paclitaxel: 175mg/m^2 every 2 weeks for 4 cycles
Week 52 IVAD Removal, Bone marrow aspiration
Follow-Up (up to 5 years) Q 3 months for year 1 Q 6 months for year 2-3 Q 1 year for years 4-5
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Missouri
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St. Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Patients must be >= 18 years of age
- Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.
- Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3).
- Tumor does not express the following biomarkers: estrogen receptor, progesterone receptor, Her2/neu
Adequate organ function defined as:
- Serum Creatinine <= 1.5 x upper limit of institutional normal.
- ALT, AST, ALK Phos <= 1.5 x upper limit of institutional normal.
- Bilirubin <= 1.5 x upper limit of institutional normal.
- Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.
Exclusion Criteria:
- No evidence of distant metastasis present by CT, Bone scan, or physical exam. If the bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions should be further clarified by additional testing such as PET or MRI.
- No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin or history of previous malignancies, treated with at least greater than 5 years disease free survival.
- Women of child bearing potential may not be currently pregnant or breastfeeding at time of registration and must agree to use adequate contraception.
- Karnofsky Performance Status of <= 70.
- Patients with known history neural deficiencies (e.g. peripheral neuropathy).
- Patients with a known hearing impairment (hearing loss or severe tinnitus).
- Male patients
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: Cisplatin + Radiation + Recommended Surgery
Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10 Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks. Surgery (recommended) mastectomy with/without axillary lymph node dissection |
Ostatní jména:
(RECOMMENDED BUT NOT REQUIRED)
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Overall Response
Časové okno: At the time of surgery (week 13)
|
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At the time of surgery (week 13)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Time to Disease Progression
Časové okno: Until study was terminated (23.5 months)
|
Time to disease progression: time from registration until objective tumor progression; does not include deaths
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Until study was terminated (23.5 months)
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Overall Survival Rate (OS)
Časové okno: Until study was terminated (23.5 months)
|
OS = Time from registration until death from any cause
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Until study was terminated (23.5 months)
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Number of Participants With Surgical Complications
Časové okno: 30 days post surgery (week 17-18)
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30 days post surgery (week 17-18)
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Number of Participants With Medical Toxicities
Časové okno: 30 days post surgery (week 17-18)
|
The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 will be utilized for all toxicity reporting.
All detailed information regarding serious and other adverse events are listed in the Adverse Event module of these results.
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30 days post surgery (week 17-18)
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Effect of Neoadjuvant Chemoradiation Therapy in Disseminated Cancer Cells in the Bone Marrow and Correlation to Tumor Response
Časové okno: 5 years
|
5 years
|
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Develop Animal Models of Triple Negative Breast Cancers
Časové okno: 5 years
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5 years
|
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Provide Samples for the Development of the FNA Assay
Časové okno: At time of IVAD placement and at time of surgery
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At time of IVAD placement and at time of surgery
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Rebecca Aft, MD, PhD, Washington University School of Medicine
Publikace a užitečné odkazy
Obecné publikace
- Sorlie T, Perou CM, Tibshirani R, Aas T, Geisler S, Johnsen H, Hastie T, Eisen MB, van de Rijn M, Jeffrey SS, Thorsen T, Quist H, Matese JC, Brown PO, Botstein D, Lonning PE, Borresen-Dale AL. Gene expression patterns of breast carcinomas distinguish tumor subclasses with clinical implications. Proc Natl Acad Sci U S A. 2001 Sep 11;98(19):10869-74. doi: 10.1073/pnas.191367098.
- Carey LA, Perou CM, Livasy CA, Dressler LG, Cowan D, Conway K, Karaca G, Troester MA, Tse CK, Edmiston S, Deming SL, Geradts J, Cheang MC, Nielsen TO, Moorman PG, Earp HS, Millikan RC. Race, breast cancer subtypes, and survival in the Carolina Breast Cancer Study. JAMA. 2006 Jun 7;295(21):2492-502. doi: 10.1001/jama.295.21.2492.
- Cleator S, Heller W, Coombes RC. Triple-negative breast cancer: therapeutic options. Lancet Oncol. 2007 Mar;8(3):235-44. doi: 10.1016/S1470-2045(07)70074-8.
- Turner NC, Reis-Filho JS. Basal-like breast cancer and the BRCA1 phenotype. Oncogene. 2006 Sep 25;25(43):5846-53. doi: 10.1038/sj.onc.1209876.
- Turner NC, Reis-Filho JS, Russell AM, Springall RJ, Ryder K, Steele D, Savage K, Gillett CE, Schmitt FC, Ashworth A, Tutt AN. BRCA1 dysfunction in sporadic basal-like breast cancer. Oncogene. 2007 Mar 29;26(14):2126-32. doi: 10.1038/sj.onc.1210014. Epub 2006 Oct 2.
- Garber, J., Richardson, A., Harris, L., Miron, A., Silver, D., Golshan, M., Ryan, P., Ganesan, S., Wang, Z., Clarke, K., Inglehart, J., and Winer, E. Neoadjuvant cisplatin in triple negative breast cancer. SABCS, 2006.
- Bollet MA, Sigal-Zafrani B, Gambotti L, Extra JM, Meunier M, Nos C, Dendale R, Campana F, Kirova YM, Dieras V, Fourquet A; Institut Curie Breast Cancer Study Group. Pathological response to preoperative concurrent chemo-radiotherapy for breast cancer: results of a phase II study. Eur J Cancer. 2006 Sep;42(14):2286-95. doi: 10.1016/j.ejca.2006.03.026. Epub 2006 Aug 8.
- Formenti SC, Volm M, Skinner KA, Spicer D, Cohen D, Perez E, Bettini AC, Groshen S, Gee C, Florentine B, Press M, Danenberg P, Muggia F. Preoperative twice-weekly paclitaxel with concurrent radiation therapy followed by surgery and postoperative doxorubicin-based chemotherapy in locally advanced breast cancer: a phase I/II trial. J Clin Oncol. 2003 Mar 1;21(5):864-70. doi: 10.1200/JCO.2003.06.132.
- Whitney CW, Sause W, Bundy BN, Malfetano JH, Hannigan EV, Fowler WC Jr, Clarke-Pearson DL, Liao SY. Randomized comparison of fluorouracil plus cisplatin versus hydroxyurea as an adjunct to radiation therapy in stage IIB-IVA carcinoma of the cervix with negative para-aortic lymph nodes: a Gynecologic Oncology Group and Southwest Oncology Group study. J Clin Oncol. 1999 May;17(5):1339-48. doi: 10.1200/JCO.1999.17.5.1339.
- Morris M, Eifel PJ, Lu J, Grigsby PW, Levenback C, Stevens RE, Rotman M, Gershenson DM, Mutch DG. Pelvic radiation with concurrent chemotherapy compared with pelvic and para-aortic radiation for high-risk cervical cancer. N Engl J Med. 1999 Apr 15;340(15):1137-43. doi: 10.1056/NEJM199904153401501.
- Keys HM, Bundy BN, Stehman FB, Muderspach LI, Chafe WE, Suggs CL 3rd, Walker JL, Gersell D. Cisplatin, radiation, and adjuvant hysterectomy compared with radiation and adjuvant hysterectomy for bulky stage IB cervical carcinoma. N Engl J Med. 1999 Apr 15;340(15):1154-61. doi: 10.1056/NEJM199904153401503. Erratum In: N Engl J Med 1999 Aug 26;341(9):708.
- Rowinsky EK, Donehower RC. Paclitaxel (taxol). N Engl J Med. 1995 Apr 13;332(15):1004-14. doi: 10.1056/NEJM199504133321507. No abstract available. Erratum In: N Engl J Med 1995 Jul 6;333(1):75.
- Rowinsky EK, Chaudhry V, Forastiere AA, Sartorius SE, Ettinger DS, Grochow LB, Lubejko BG, Cornblath DR, Donehower RC. Phase I and pharmacologic study of paclitaxel and cisplatin with granulocyte colony-stimulating factor: neuromuscular toxicity is dose-limiting. J Clin Oncol. 1993 Oct;11(10):2010-20. doi: 10.1200/JCO.1993.11.10.2010.
- Diel IJ, Cote RJ. Bone marrow and lymph node assessment for minimal residual disease in patients with breast cancer. Cancer Treat Rev. 2000 Feb;26(1):53-65. doi: 10.1053/ctrv.1999.0150.
- Braun S, Pantel K, Muller P, Janni W, Hepp F, Kentenich CR, Gastroph S, Wischnik A, Dimpfl T, Kindermann G, Riethmuller G, Schlimok G. Cytokeratin-positive cells in the bone marrow and survival of patients with stage I, II, or III breast cancer. N Engl J Med. 2000 Feb 24;342(8):525-33. doi: 10.1056/NEJM200002243420801. Erratum In: N Engl J Med 2000 Jul 27;343(4):308.
- Braun S, Naume B. Circulating and disseminated tumor cells. J Clin Oncol. 2005 Mar 10;23(8):1623-6. doi: 10.1200/JCO.2005.10.073. No abstract available.
- Janni W, Rack B, Schindlbeck C, Strobl B, Rjosk D, Braun S, Sommer H, Pantel K, Gerber B, Friese K. The persistence of isolated tumor cells in bone marrow from patients with breast carcinoma predicts an increased risk for recurrence. Cancer. 2005 Mar 1;103(5):884-91. doi: 10.1002/cncr.20834.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 07-0913
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