Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer
NCT ID: NCT00129922
Last Updated: 2023-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1289 participants
INTERVENTIONAL
1999-11-30
2007-12-31
Brief Summary
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Also, for axillary positive node patients, optimum chemotherapy regimens are still under discussion. Some previous studies suggest that, in the subset of node-positive patients, treatments based on sequential administration of anthracyclines and taxanes are more efficient. Paclitaxel dose-dense (weekly) administration renders an improved therapeutic index (activity/toxicity).
The study is designed to compare 6 courses of FEC scheme (600/90/600), a combination of proven efficacy in node positive breast cancer patients, versus 4 FEC courses followed by 8 weekly paclitaxel administrations (100mg/m2).
The study hypothesis is that 5-year disease-free survival in the control arm will be 60%. The investigators expect to increase this by 8% with the experimental treatment. With an alpha error of 0.05, 80% power, and a post-randomization estimated drop-out rate of 10%, 1250 patients are needed, 625 per arm.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fluorouracil+Epirubicin+Cyclophosphamide
5-FU+4-Epirubicin+Cyclophosphamide
Fluorouracil
Epirubicin
Cyclophosphamide
FEC followed by Paclitaxel
5-FU+4-Epirubicin+Cyclophosphamide
paclitaxel
Fluorouracil
Epirubicin
Cyclophosphamide
Interventions
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paclitaxel
Fluorouracil
Epirubicin
Cyclophosphamide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histological diagnosis of breast cancer.
* Node positive operable breast cancer (stages II-III).
* Breast cancer surgery, consisting of radical mastectomy or conservative surgery, plus lymphadenectomy with at least 6 extirpated nodes. Surgery must have happened in the 8 weeks prior to randomisation.
* Age \>=18 and \<= 70 years old.
* Negative pregnancy test. Adequate contraceptive method during the study participation.
* Performance status of 90-100 (Karnofsky index) or ECOG \<=1.
* Haemoglobin \>= 10 g/dl; neutrophils \> 1,500/cc; platelets \> 100,000/cc.
* Adequate hepatic function with bilirubin, SGOT and SGPT \< 1.5 x upper normal limit (UNL).
* Adequate cardiac function documented by left ventricular ejection fraction (LVEF).
* Adequate renal function with creatinine \< 1.5 mg/dl.
Exclusion Criteria
* Bilateral breast cancer. Lobular in situ carcinoma.
* Previous or current malignancies, except for basal skin carcinoma, cervical in situ carcinoma or superficial bladder carcinoma, adequately treated.
* History of arrhythmias and/or congestive heart failure or cardiac blocking grade 2-3; history of myocardial infarction in 6 months before recruitment.
* Inability for treatment and study compliance.
* Pregnant or lactating women.
* Active infection.
* History of hypersensitivity to cremophor or cyclosporine.
* Pre-existing grade 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria \[NCI CTC\]).
* Hormonal receptor status not determined.
* Any other criteria which, in investigator's opinion, may jeopardize patient's security or compliance.
* Administration of other investigational product in the 30 days prior to randomisation; current participation in another clinical trial.
18 Years
70 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Pfizer
INDUSTRY
Hoffmann-La Roche
INDUSTRY
Spanish Breast Cancer Research Group
OTHER
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Hospital General Universitario de Elche
Study Director
Role: STUDY_DIRECTOR
Hospital Universitario Marqués de Valdecilla
Study Director
Role: STUDY_DIRECTOR
Hospital Provincial de Córdoba
Locations
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Hospital Universitario Virgen de los Lirios
Alcoy, Alicante, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital General Universitario de Elda
Elda, Alicante, Spain
Hospital Municipal de Badalona
Badalona, Barcelona, Spain
Hospital Unviersitario Germans Trias i Pujol
Badalona, Barcelona, Spain
Althaia-Xarxa Assistencial de Manresa
Manresa, Barcelona, Spain
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain
Hospital Espíritu Santo
Santa Coloma de Gramenet, Barcelona, Spain
Hospital Universitario Mutua de Terrassa
Terrassa, Barcelona, Spain
Consorci Sanitari de Terrassa
Terrassa, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain
Hospital Universitario Puerto Real
Puerto Real, Cádiz, Spain
Onkologikoa
Donostia / San Sebastian, Gupúzcoa, Spain
Hospital Donostia
Donostia / San Sebastian, Gupúzcoa, Spain
Hospital de Barbastro
Barbastro, Huesca, Spain
Hospital Universitario de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, Las Palmas, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil
Las Palmas de Gran Canaria, Las Palmas, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain
Hospital Universitario de Móstoles
Móstoles, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Hospital de Cabueñes
Gijón, Principality of Asturias, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
Hospital Universitario San Joan de Reus
Reus, Tarragona, Spain
Hospital de la Ribera
Alzira, Valencia, Spain
Hospital de Sagunto
Sagunto, Valencia, Spain
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain
Complejo Hospitalario Universitario A Coruña
A Coruña, , Spain
Centro Oncológico de Galicia
A Coruña, , Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital del Mar
Barcelona, , Spain
Clínica Oncológica Corachán
Barcelona, , Spain
Hospital Clinic i Provincial
Barcelona, , Spain
Hospital Universitario Puerta del Mar
Cadiz, , Spain
Hospital General Universitario de Ciudad Real
Ciudad Real, , Spain
Hospital Provincial de Córdoba
Córdoba, , Spain
Hospital General Universitario de Guadalajara
Guadalajara, , Spain
Hospital Juan Ramón Jiménez
Huelva, , Spain
Complejo Hospitalario de Jaén
Jaén, , Spain
Hospital de León
León, , Spain
Hospital Universitario Lucus Augusti
Lugo, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Clínico Universitario San Carlos
Madrid, , Spain
Hospital Clínico Unviersitario Virgen de la Victoria
Málaga, , Spain
Hospital General Universitario Morales Meseguer
Murcia, , Spain
Complejo Hospitalario de Ourense
Ourense, , Spain
Hospital Rio Carrión
Palencia, , Spain
Hospital Unviersitario de Salamanca
Salamanca, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Virgen de la Salud
Toledo, , Spain
Hospital Provincial de Toledo
Toledo, , Spain
Hospital Universitario La Fe
Valencia, , Spain
Instituto Valenciano de Oncología
Valencia, , Spain
Hospital Clínico Universitario de Valencia
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Universitario Arnau de Vilanova de Valencia
Valencia, , Spain
Hospital Universitario Dr. Peset
Valencia, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Hospital Provincial de Zamora
Zamora, , Spain
Hospital Clínico Universitario de Zaragoza "Lozano Blesa"
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Hospital de Txagorritxu
Vitoria-Gasteiz, Álava, Spain
Countries
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References
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Martin M, Rodriguez-Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, Santaballa A, Rodriguez CA, Crespo C, Abad M, Dominguez S, Florian J, Llorca C, Mendez M, Godes M, Cubedo R, Murias A, Batista N, Garcia MJ, Caballero R, de Alava E. Molecular predictors of efficacy of adjuvant weekly paclitaxel in early breast cancer. Breast Cancer Res Treat. 2010 Aug;123(1):149-57. doi: 10.1007/s10549-009-0663-z.
Ebbert MT, Bastien RR, Boucher KM, Martin M, Carrasco E, Caballero R, Stijleman IJ, Bernard PS, Facelli JC. Characterization of uncertainty in the classification of multivariate assays: application to PAM50 centroid-based genomic predictors for breast cancer treatment plans. J Clin Bioinforma. 2011 Dec 23;1:37. doi: 10.1186/2043-9113-1-37.
de la Haba-Rodriguez J, Rodriguez-Lescure A, Ruiz A, Alba E, Calvo L, Carrasco E, Escudero MJ, Martin M. Regional and seasonal influence in patient's toxicity to adjuvant chemotherapy for early breast cancer. Breast Cancer Res Treat. 2011 Jan;125(1):273-8. doi: 10.1007/s10549-010-1136-0. Epub 2010 Aug 28.
Bastien RR, Rodriguez-Lescure A, Ebbert MT, Prat A, Munarriz B, Rowe L, Miller P, Ruiz-Borrego M, Anderson D, Lyons B, Alvarez I, Dowell T, Wall D, Segui MA, Barley L, Boucher KM, Alba E, Pappas L, Davis CA, Aranda I, Fauron C, Stijleman IJ, Palacios J, Anton A, Carrasco E, Caballero R, Ellis MJ, Nielsen TO, Perou CM, Astill M, Bernard PS, Martin M. PAM50 breast cancer subtyping by RT-qPCR and concordance with standard clinical molecular markers. BMC Med Genomics. 2012 Oct 4;5:44. doi: 10.1186/1755-8794-5-44.
Pajares B, Pollan M, Martin M, Mackey JR, Lluch A, Gavila J, Vogel C, Ruiz-Borrego M, Calvo L, Pienkowski T, Rodriguez-Lescure A, Segui MA, Tredan O, Anton A, Ramos M, Camara Mdel C, Rodriguez-Martin C, Carrasco E, Alba E. Obesity and survival in operable breast cancer patients treated with adjuvant anthracyclines and taxanes according to pathological subtypes: a pooled analysis. Breast Cancer Res. 2013 Nov 6;15(6):R105. doi: 10.1186/bcr3572.
Martin M, Prat A, Rodriguez-Lescure A, Caballero R, Ebbert MT, Munarriz B, Ruiz-Borrego M, Bastien RR, Crespo C, Davis C, Rodriguez CA, Lopez-Vega JM, Furio V, Garcia AM, Casas M, Ellis MJ, Berry DA, Pitcher BN, Harris L, Ruiz A, Winer E, Hudis C, Stijleman IJ, Tuck DP, Carrasco E, Perou CM, Bernard PS. PAM50 proliferation score as a predictor of weekly paclitaxel benefit in breast cancer. Breast Cancer Res Treat. 2013 Apr;138(2):457-66. doi: 10.1007/s10549-013-2416-2. Epub 2013 Feb 20.
Prat A, Cheang MC, Martin M, Parker JS, Carrasco E, Caballero R, Tyldesley S, Gelmon K, Bernard PS, Nielsen TO, Perou CM. Prognostic significance of progesterone receptor-positive tumor cells within immunohistochemically defined luminal A breast cancer. J Clin Oncol. 2013 Jan 10;31(2):203-9. doi: 10.1200/JCO.2012.43.4134. Epub 2012 Dec 10.
Martin M, Brase JC, Calvo L, Krappmann K, Ruiz-Borrego M, Fisch K, Ruiz A, Weber KE, Munarriz B, Petry C, Rodriguez CA, Kronenwett R, Crespo C, Alba E, Carrasco E, Casas M, Caballero R, Rodriguez-Lescure A. Clinical validation of the EndoPredict test in node-positive, chemotherapy-treated ER+/HER2- breast cancer patients: results from the GEICAM 9906 trial. Breast Cancer Res. 2014 Apr 12;16(2):R38. doi: 10.1186/bcr3642.
Cheang MC, Martin M, Nielsen TO, Prat A, Voduc D, Rodriguez-Lescure A, Ruiz A, Chia S, Shepherd L, Ruiz-Borrego M, Calvo L, Alba E, Carrasco E, Caballero R, Tu D, Pritchard KI, Levine MN, Bramwell VH, Parker J, Bernard PS, Ellis MJ, Perou CM, Di Leo A, Carey LA. Defining breast cancer intrinsic subtypes by quantitative receptor expression. Oncologist. 2015 May;20(5):474-82. doi: 10.1634/theoncologist.2014-0372. Epub 2015 Apr 23.
Martin M, Brase JC, Ruiz A, Prat A, Kronenwett R, Calvo L, Petry C, Bernard PS, Ruiz-Borrego M, Weber KE, Rodriguez CA, Alvarez IM, Segui MA, Perou CM, Casas M, Carrasco E, Caballero R, Rodriguez-Lescure A. Prognostic ability of EndoPredict compared to research-based versions of the PAM50 risk of recurrence (ROR) scores in node-positive, estrogen receptor-positive, and HER2-negative breast cancer. A GEICAM/9906 sub-study. Breast Cancer Res Treat. 2016 Feb;156(1):81-9. doi: 10.1007/s10549-016-3725-z. Epub 2016 Feb 24.
Templeton AJ, Rodriguez-Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, Santaballa A, Rodriguez CA, Crespo C, Ramos M, Gracia-Marco JM, Lluch A, Alvarez I, Casas MI, Sanchez-Arago M, Caballero R, Carrasco E, Amir E, Martin M, Ocana A; GEICAM 9906 Study Investigators. Prognostic role for the derived neutrophil-to-lymphocyte ratio in early breast cancer: a GEICAM/9906 substudy. Clin Transl Oncol. 2018 Dec;20(12):1548-1556. doi: 10.1007/s12094-018-1885-5. Epub 2018 May 15.
Sestak I, Martin M, Dubsky P, Kronenwett R, Rojo F, Cuzick J, Filipits M, Ruiz A, Gradishar W, Soliman H, Schwartzberg L, Buus R, Hlauschek D, Rodriguez-Lescure A, Gnant M. Prediction of chemotherapy benefit by EndoPredict in patients with breast cancer who received adjuvant endocrine therapy plus chemotherapy or endocrine therapy alone. Breast Cancer Res Treat. 2019 Jul;176(2):377-386. doi: 10.1007/s10549-019-05226-8. Epub 2019 Apr 30.
Camp NJ, Madsen MJ, Herranz J, Rodriguez-Lescure A, Ruiz A, Martin M, Bernard PS. Re-interpretation of PAM50 gene expression as quantitative tumor dimensions shows utility for clinical trials: application to prognosis and response to paclitaxel in breast cancer. Breast Cancer Res Treat. 2019 May;175(1):129-139. doi: 10.1007/s10549-018-05097-5. Epub 2019 Jan 23.
Ethier JL, Ocana A, Rodriguez Lescure A, Ruiz A, Alba E, Calvo L, Ruiz-Borrego M, Santaballa A, Rodriguez CA, Crespo C, Ramos M, Gracia Marco J, Lluch A, Alvarez I, Casas M, Sanchez-Arago M, Carrasco E, Caballero R, Amir E, Martin M. Outcomes of single versus double hormone receptor-positive breast cancer. A GEICAM/9906 sub-study. Eur J Cancer. 2018 May;94:199-205. doi: 10.1016/j.ejca.2018.02.018. Epub 2018 Mar 21.
Martin M, Carrasco E, Rodriguez-Lescure A, Andres R, Servitja S, Anton A, Ruiz-Borrego M, Bermejo B, Guerrero A, Ramos M, Santaballa A, Munoz M, Cruz J, Lopez-Tarruella S, Chacon JI, Alvarez I, Martinez P, Miralles JJ, Polonio O, Jara C, Aguiar-Bujanda D. Long-term outcomes of high-risk HR-positive and HER2-negative early breast cancer patients from GEICAM adjuvant studies and El Alamo IV registry. Breast Cancer Res Treat. 2023 Sep;201(2):151-159. doi: 10.1007/s10549-023-07002-1. Epub 2023 Jun 20.
Related Links
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Click here for more information about this study: GEICAM 9906
Other Identifiers
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GEICAM 9906
Identifier Type: -
Identifier Source: org_study_id
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