Breast Cancer Clinical Trial
Official title:
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
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.
PURPOSE: 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.
Status | Completed |
Enrollment | 1856 |
Est. completion date | |
Est. primary completion date | November 2006 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 70 Years |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed breast cancer - Locally advanced or inflammatory disease - T4a-d, any N, M0 OR - Any T, N2 or N3, M0 - Large operable T2 or T3 tumors - No bilateral breast cancer - Frozen tumor sample available - 1 incisional biopsy OR - 2 trucut biopsies from a 14G needle - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 70 and under Sex: - Female Menopausal status: - Not specified Performance status: - WHO 0-1 Life expectancy: - Not specified Hematopoietic: - Neutrophil count greater than 1,500/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - Bilirubin less than 1.2 mg/dL - SGOT less than 60 IU/L Renal: - Creatinine less than 1.35 mg/dL Cardiovascular: - LVEF normal by echocardiography or MUGA Other: - No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No serious uncontrolled medical condition - No uncontrolled psychiatric or addictive disorders - Not pregnant or nursing - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy Surgery: - See Disease Characteristics |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | Institut Jules Bordet | Brussels | |
Belgium | CHU Liege - Domaine Universitaire du Sart Tilman | Liege | |
Belgium | Algemeen Ziekenhuis Sint-Augustinus | Wilrijk | |
France | Centre Paul Papin | Angers | |
France | Institut Bergonie | Bordeaux | |
France | Centre de Lutte Contre le Cancer Georges-Francois Leclerc | Dijon | |
France | Centre Hospitalier Departemental | La Roche Sur Yon | |
France | Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle | Montpellier | |
France | Centre Regional Rene Gauducheau | Nantes-Saint Herblain | |
France | Centre Henri Becquerel | Rouen | |
France | Centre Rene Huguenin | Saint Cloud | |
France | Centre Paul Strauss | Strasbourg | |
France | Centre Alexis Vautrin | Vandoeuvre-les-Nancy | |
Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | |
Netherlands | Leiden University Medical Center | Leiden | |
Netherlands | Daniel Den Hoed Cancer Center at Erasmus Medical Center | Rotterdam | |
Poland | Medical University of Gdansk | Gdansk | |
Poland | Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | Warsaw | |
Portugal | Hospitais da Universidade de Coimbra (HUC) | Coimbra | |
Portugal | Instituto Portugues de Oncologia de Francisco Gentil - Centro Regional de Oncologia de Lisboa, S.A. | Lisbon | |
Slovenia | Institute of Oncology - Ljubljana | Ljubljana | |
Sweden | Sahlgrenska University Hospital at Gothenburg University | Gothenburg (Goteborg) | |
Sweden | Lund University Hospital | Lund | |
Sweden | Malmo University Hospital | Malmo | |
Sweden | Sahlgrenska University Hospital - Molndal at Gothenburg University | Molndal | |
Sweden | Orebro University Hospital | Orebro | |
Sweden | Karolinska University Hospital - Huddinge | Stockholm | |
Sweden | Uppsala University Hospital | Uppsala | |
Switzerland | Kantonspital Aarau | Aarau | |
Switzerland | Inselspital Bern | Bern | |
Switzerland | Swiss Institute for Applied Cancer Research | Bern | |
Switzerland | Hopital Cantonal Universitaire de Geneve | Geneva | |
Switzerland | Centre Hospitalier Universitaire Vaudois | Lausanne | |
Switzerland | UniversitaetsSpital Zuerich | Zurich | |
United Kingdom | Ninewells Hospital and Medical School | Dundee | Scotland |
United Kingdom | Edinburgh Cancer Centre at Western General Hospital | Edinburgh | Scotland |
United Kingdom | Scottish Cancer Therapy Network | Edinburgh | Scotland |
United Kingdom | Northern Centre for Cancer Treatment at Newcastle General Hospital | Newcastle Upon Tyne | England |
United Kingdom | Royal South Hants Hospital | Southampton | England |
Lead Sponsor | Collaborator |
---|---|
European Organisation for Research and Treatment of Cancer - EORTC | Anglo Celtic Cooperative Oncology Group, Swedish Breast Cancer Group, Swiss Group for Clinical Cancer Research |
Belgium, France, Netherlands, Poland, Portugal, Slovenia, Sweden, Switzerland, United Kingdom,
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 i
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, André S, Litière S, Lago LD, Becette V, Cameron DA, Bergh J, Iggo R; EORTC 10994/BIG 1-00 Study Investigat — View 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, André 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. — View 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, André S, Acharya CR, Mukherjee S, Cameron D, Bergh J, Nevins JR, Iggo RD. Validation of gene signatures that predict the re — View 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 Antoni
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
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/S1470-204 — View 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. — View 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.
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/infla
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Progression-free survival | from randomization till first evidence of progression | No | |
Secondary | Distant metastasis-free survival | randomization till first evidence recurrence | No | |
Secondary | Overall survival | randomization till death | No | |
Secondary | Clinical and pathological responses | after 3rd and 6d cycle of chemotherapy | No | |
Secondary | Clinical response according to RECIST criteria without pathologic response | after 3rd and 6d cycle of chemotherapy | No | |
Secondary | Toxicity according to CTC v2.0 | from randomization | Yes | |
Secondary | 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 | after 3 and 6 cycles of chemotherapy | No | |
Secondary | Tumor assessment using cDNA microarray technology | end of treatment | No |
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