AzTrials
AzTrials

Breast CancerPhase 3NCT00129922

Fluorouracil, Epirubicin, and Cyclophosphamide Alone or Followed by Paclitaxel for Early Breast Cancer

A Phase 3 study testing paclitaxel, Fluorouracil and Epirubicin in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 64 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence. Also, for axillary positive node patients, optimum chemotherapy regimens are still under discussion. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
paclitaxel, Fluorouracil and Epirubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,289 participants
Where
64 sitesSpain
Study dates
Nov 1999to Dec 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent.
  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • Previous chemotherapy, hormone therapy and/or radiotherapy for breast cancer.
  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

Spain64 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Centro Oncológico de Galicia

    A Coruña, 15009

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital Universitario Virgen de los Lirios

    Alcoy, Alicante, 03804

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital de la Ribera

    Alzira, Valencia, 46600

  • Hospital Municipal de Badalona

    Badalona, Barcelona, 08911

  • Hospital Unviersitario Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitario Cruces

    Barakaldo, Vizcaya, 48903

  • Hospital de Barbastro

    Barbastro, Huesca, 22300

  • Hospital del Mar

    Barcelona, 08003

  • Clínica Oncológica Corachán

    Barcelona, 08017

  • Hospital Clinic i Provincial

    Barcelona, 08036

  • Hospital Universitario Puerta del Mar

    Cadiz, 11009

  • Hospital General Universitario de Ciudad Real

    Ciudad Real, 13005

  • Hospital Provincial de Córdoba

    Córdoba, 14004

  • Onkologikoa

    Donostia / San Sebastian, Gupúzcoa, 20012

  • Hospital Donostia

    Donostia / San Sebastian, Gupúzcoa, 20014

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital General Universitario de Elda

    Elda, Alicante, 03600

  • Hospital de Cabueñes

    Gijón, Principality of Asturias, 33394

  • Hospital General Universitario de Guadalajara

    Guadalajara, 19002

  • Hospital Juan Ramón Jiménez

    Huelva, 21005

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital de Jerez de la Frontera

    Jerez de la Frontera, Cádiz, 11407

  • Hospital Universitario de Gran Canaria Dr. Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35010

  • Complejo Hospitalario Universitario Insular-Materno Infantil

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • Hospital de León

    León, 24071

  • Hospital Universitario Lucus Augusti

    Lugo, 27004

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro

    Majadahonda, Madrid, 28222

  • Hospital Clínico Unviersitario Virgen de la Victoria

    Málaga, 29010

  • Althaia-Xarxa Assistencial de Manresa

    Manresa, Barcelona, 08240

  • Hospital Universitario de Móstoles

    Móstoles, Madrid, 28935

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Complejo Hospitalario de Ourense

    Ourense, 32005

  • Hospital Rio Carrión

    Palencia, 34005

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Puerto Real

    Puerto Real, Cádiz, 11510

  • Hospital Universitario San Joan de Reus

    Reus, Tarragona, 43204

  • Corporació Sanitaria Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital de Sagunto

    Sagunto, Valencia, 46520

  • Hospital Unviersitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Hospital Espíritu Santo

    Santa Coloma de Gramenet, Barcelona, 08923

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Universitario Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

  • Hospital Virgen de la Salud

    Toledo, 45005

  • Hospital Provincial de Toledo

    Toledo, 45006

  • Hospital Universitario La Fe

    Valencia, 46009

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitario Arnau de Vilanova de Valencia

    Valencia, 46015

  • Hospital Universitario Dr. Peset

    Valencia, 46017

  • Hospital Clínico Universitario de Valladolid

    Valladolid, 47003

  • Hospital de Txagorritxu

    Vitoria-Gasteiz, Álava, 01009

  • Hospital Provincial de Zamora

    Zamora, 49021

  • Hospital Clínico Universitario de Zaragoza "Lozano Blesa"

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Phase III Study to Compare 6 Courses of FEC (Fluorouracil, Epirubicin and Cyclophosphamide) vs. 4 Courses of FEC Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Positive Operable BC Patients

The efficacy of adjuvant chemotherapy is limited in patients with a high risk of recurrence.

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).

Read more

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.

Read the detailed description

The primary endpoint of study-5-year disease-free survival (DFS) will be assessed by Kaplan Meier analysis. Secondary endpoints included overall survival and analysis of the prognostic and predictive value of clinical and molecular markers. Associations and interactions will be assessed with a multivariable Cox proportional hazards model for DFS for the following covariates: age, menopausal status, tumor size, lymph node status, type of chemotherapy, tumor size, positive lymph nodes, HER2 status, and hormone receptor status. All statistical tests will be two-sided.

Conditions
Breast Cancer
Keywords
Axillary node positive breast cancer., Sequential drug administration., Weekly paclitaxel.
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00129922
Study groupRoleWhat they receive
Fluorouracil+Epirubicin+CyclophosphamideActive comparator5-FU+4-Epirubicin+Cyclophosphamide
Receives: Drug: Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide
FEC followed by PaclitaxelExperimental5-FU+4-Epirubicin+Cyclophosphamide
Receives: Drug: paclitaxel; Drug: Fluorouracil; Drug: Epirubicin; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. disease-free survival

    From the date of randomization of each patient included to the 1st documented evidence of recurrence

    Measured: 5 years

Secondary outcomes (1)

  1. Overall survival

    Overall survival will be measured from the day of randomization to the date of death from any cause

    Measured: From date of randomization until the date of death from any cause, assessed up to 100 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2005 (estimated)
  2. Study startNov 1999
  3. Primary completionDec 2005
  4. Study completionDec 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,289 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129922
Sponsor's protocol ID
GEICAM 9906
Status last verified
Mar 2023
First submitted
10 Aug 2005
Last updated
6 Mar 2023
Results posted
No

Publications

  • 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.

    PubMed 20037779

  • 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.

    PubMed 22196354

  • 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.

    PubMed 20803065

  • 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.

    PubMed 23035882

  • 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.

    PubMed 24192331

  • 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.

    PubMed 23423445

  • 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.

    PubMed 23233704

  • 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.

    PubMed 24725534

  • 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.

    PubMed 25908555

  • 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.

    PubMed 26909792

  • 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.

    PubMed 29766456

  • 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.

    PubMed 31041683

  • 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.

    PubMed 30673970

  • 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.

    PubMed 29573665

  • Garcia-Saenz JA, Spera G, Pollan M, Bermejo B, Ruiz-Borrego M, Chan A, Martin M, Guerrero-Zotano A, Calvo L, Rodriguez-Lescure A, Marin M, Chap L, Crown J, Pienkowski T, Bee V, Casas M, Polonio O, Bezares S, Slamon D. Body mass index as a predictive factor for efficacy of adjuvant taxane-based chemotherapy in early-stage breast cancer patients: A pooled analysis from adjuvant GEICAM Spanish Breast Cancer Group and TRIO Translational Research in Oncology Group studies. Int J Cancer. 2025 Aug 15;157(4):709-721. doi: 10.1002/ijc.35432. Epub 2025 Apr 10.

    PubMed 40207789

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing paclitaxel, Fluorouracil and Epirubicin in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 64 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

disease-free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00129922, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.

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