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Breast CancerPhase 3NCT00129389

FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients

A Phase 3 study testing Fluorouracil, Doxorubicin and Cyclophosphamide in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 68 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

This is a prospective, open-label, randomized, phase III trial. Patients will be stratified after breast surgery, as per investigational site; menopausal status; node negative diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status (positive versus negative). 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?
Fluorouracil, Doxorubicin and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,925 participants
Where
68 sitesSpain
Study dates
19 Sep 2003to 1 Oct 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 diagnoses of operable invasive adenocarcinoma of the breast (T1-T3). Tumors must be Human Epidermal Growth Factor Receptor 2 (HER2) negative. Patients must be free of disease in the axilla (node negative). If lymphadenectomy is done, at least 10 nodes must be examined. If sentinel node technique is used, sentinel node must be free of disease. Patients must present at least one high risk criterion (St. Gallen, 1998) as follows:
  • Tumor size > 2 cm; and/or
  • ER and Progesterone Receptor (PgR) negative; and/or
  • Histological grade 2-3; and/or
  • Age < 35 years old.
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  • Time window between surgery and study randomization must be less than 60 days.
  • Surgery must consist of mastectomy or conservative surgery. Margins free of disease and ductal carcinoma in situ (DCIS) are required. Lobular carcinoma is not considered a positive margin.
  • Patients must not present evidence of metastatic disease.
  • Status of hormone receptors in primary tumor. Results must be available before the end of adjuvant chemotherapy.
  • Status of HER2 in primary tumor, known before randomization. Patients with Immunohistochemistry (IHC) 0 or +1 are eligible. For patients with IHC 2+, fluorescent in situ hybridization (FISH) is mandatory and result must be negative.
  • Age >= 18 and <= 70 years old.
  • Performance status (Karnofsky index) >= 80.
  • Normal electrocardiogram (EKG) in the 12 weeks prior to randomization. If needed, normal cardiac function must be confirmed by left ventricular ejection fraction (LVEF).
  • Laboratory results (within 14 days prior to randomization):
  • Hematology: neutrophils >= 1.5 x 10^9/l; platelets >= 100x 10^9/l; hemoglobin >= 10 mg/dl;
  • Hepatic function: total bilirubin <= 1 upper normal limit (UNL); Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <= 2.5 UNL; alkaline phosphatase <= 2.5 UNL. If values of AST and ALT > 1.5 UNL are associated with alkaline phosphatase > 2.5 UNL, patient is not eligible.
  • Renal function: creatinine <= 175 mmol/l (2 mg/dl); creatinine clearance >= 60 ml/min.
  • Complete stage workup during the 12 weeks prior to randomization (mammograms are allowed within a 20 week time window). All patients must have a bilateral mammogram, thorax x-ray, abdominal echography and/or computed tomography (CT)-scan. If bone pain, and/or alkaline phosphatase elevation, a bone scintigraphy is mandatory. This test is recommended for all patients. Other tests, as clinically indicated.
  • Patients able to comply with treatment and study follow-up.
  • Negative pregnancy test done in the 14 previous days to randomization.

Who cannot join

  • Prior systemic therapy for breast cancer.
  • Prior therapy with anthracyclines or taxanes (paclitaxel or docetaxel) for any malignancy.
  • Prior radiotherapy for breast cancer.
  • Bilateral invasive breast cancer.
  • Pregnant or lactating women. Adequate contraceptive methods must be used during chemotherapy and hormone therapy treatments. Negative pregnancy test in the 14 previous days to randomization.
  • Any T4 or N1-3 or M1 tumor.
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  • HER2 positive breast cancer (IHC 3+ or positive FISH result).
  • Pre-existing grade >=2 motor or sensorial neurotoxicity by the National Cancer Institute Common Toxicity Criteria (NCICTC) v-2.0.
  • Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.
  • History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.
  • Active uncontrolled infection.
  • Active peptic ulcer; unstable diabetes mellitus.
  • Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
  • Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 20 previous days before randomization.
  • Concomitant treatment with other therapy for cancer.
  • Males.

Trial locations and contacts

68 sites in 1 country.

68 sites in 1 country

Spain68 sites

  • Complejo Hospitalario Juan Canalejo

    A Coruña, 15006

  • Centro Oncológico de Galicia

    A Coruña, 15009

  • Complejo Hospitalario de Albacete

    Albacete, 2066

  • Fundación Hospital de Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital General Universitario de Alicante

    Alicante, 3010

  • Hospital Virgen de los Lirios

    Alicante, 3804

  • Hospital de la Ribera

    Alzira, Valencia, 46600

  • Hospital Germans Trias i Pujol

    Badalona, 8916

  • Hospital Comarcal de Barbastro

    Barbastro, Huesca, 22300

  • Hospital del Mar

    Barcelona, 8003

  • Clínica Corochan S.A.

    Barcelona, 8017

  • Hospital Clinic i Provincial

    Barcelona, 8036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital General de Vic

    Barcelona, 8500

  • Hospital de Basurto

    Bilbao, 48013

  • Hospital Madrid- Montepríncipe

    Boadilla del Monte, Madrid, 28660

  • Hospital General Yagüe

    Burgos, 9005

  • Hospital Puerta del Mar

    Cadiz, 11009

  • Hospital Provincial de Castellón

    Castellon, Castellón, 12002

  • Hospital General de Ciudad Real

    Ciudad Real, 13005

  • Hospital Reina Sofía

    Córdoba, 14004

  • Hospital Virgen de la Luz

    Cuenca, 16002

  • Hospital Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Hospital General Univ. De Elche

    Elche, Alicante, 3203

  • Hospital General de Elda

    Elda, Alicante, 3600

  • ICO Hospital Universitari Josep Trueta

    Girona, 17007

  • Hospital General de Guadalajara

    Guadalajara, 19002

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital General Jerez de la Frontera

    Jerez de la Frontera, Cadiz, 11407

  • Hospital Insular de Gran Canaria

    Las Palmas de Gran Canaria, Las Palmas, 35016

  • Hospital Xeral Calde

    Lugo, 27004

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital Doce de Octubre

    Madrid, 28021

  • Hospital Ramón y Cajal

    Madrid, 28034

  • Hospital Ruber Internacional

    Madrid, 28034

  • Hospital Puerta de Hierro

    Madrid, 28035

  • Hospital Clínico San Carlos

    Madrid, 28040

  • Hospital La Paz

    Madrid, 28046

  • CIOCC Hospital Norte-Sanchinarro

    Madrid, 28050

  • Complejo Hospitalario Virgen de la Victoria

    Málaga, 29010

  • Hospital Carlos Haya

    Málaga, 29010

  • Complejo Hospitalario de Manresa

    Manresa, Barcelona, 8243

  • Hospital de Móstoles

    Móstoles, Madrid, 28935

  • Hospital Morales Messeguer

    Murcia, 30008

  • Hospital Sta María Nai

    Ourense, 32005

  • Hospital General Río Carrión

    Palencia, 34005

  • Hospital Sant Joan de Reus

    Reus, Tarragona, 43201

  • Consorci Sanitari Parc Tauli

    Sabadell, Barcelona, 8208

  • Hospital Clínico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

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

  • Instituto Oncológico de Guipuzcoa

    San Sebastián, 20012

  • Hospital de Donostia

    San Sebastián, 20014

  • Hospital del Espíritu Santo

    Santa Coloma de Gramenet, Barcelona, 8923

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008

  • Hospital Univ. Virgen del Rocío

    Seville, 41013

  • Hospital Universitario de Valme

    Seville, 41014

  • Consorci Sanitari Terrassa

    Terrassa, Barcelona, 8221

  • Hospital Mutua Terrassa

    Terrassa, Barcelona, 8221

  • Hospital Virgen de la Salud

    Toledo, 45004

  • Hospital Universitario La Fe

    Valencia, 46009

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

  • Hospital Arnau de Vilanova

    Valencia, 46015

  • Hospital Policlínico Vigo POVISA

    Vigo, Pontevedra, 36211

  • Hospital Txagorritxu

    Vitoria-Gasteiz, 1009

  • Hospital Provincial de Zamora

    Zamora, 49021

  • Hospital Lozano Blesa

    Zaragoza, 50009

  • Hospital Miguel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Multicenter Randomized Phase III Trial to Compare 6 FAC Cycles vs 4 FAC Cycles Followed by 8 Weekly Paclitaxel Administrations, as Adjuvant Treatment for Node Negative Operable Breast Cancer Patients

This is a prospective, open-label, randomized, phase III trial. Patients will be stratified after breast surgery, as per investigational site; menopausal status; node negative diagnosis, as per sentinel-node technique versus lymphadenectomy; hormone receptor status (positive versus negative).

Read the detailed description

Patients will be randomized to:

  • Fluorouracil, doxorubicin, and cyclophosphamide (FAC) x 6 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50 mg/m2 + cyclophosphamide 500 mg/m2 day 1, every 3 weeks, for 6 cycles.
  • FAC x 4 (cycles) → Paclitaxel x 8 (cycles): 5-fluorouracil 500 mg/m2 + doxorubicin 50 mg/m2 + cyclophosphamide 500 mg/m2 day 1, every 3 weeks, for 4 cycles, followed by 8 administrations of weekly paclitaxel 100 mg/m2

Premenopausal women with hormone receptor positive tumors must receive tamoxifen 20 mg daily for 5 years, after the end of chemotherapy.

Postmenopausal women with hormone receptor positive tumors are allowed to receive aromatase inhibitors as initial adjuvant hormone therapy or after tamoxifen.

All patients with breast conservative surgery must receive radiotherapy.

Estimated 5-year disease-free survival in the control arm (FAC x 6) is expected to be 80%. It is expected that disease-free survival will increase by 5% in the experimental arm (FAC-paclitaxel). 906 patients per arm must be recruited, to detect this difference with an alpha error of 0.05 and 80% power. Assuming a 6% post-randomization drop-out rate, 960 patients per arm are needed, 1920 in total.

Conditions
Breast Cancer
Keywords
Node negative, high risk breast cancer., Prognostic gene profile., Saint Gallen high risk criteria., 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 NCT00129389
Study groupRoleWhat they receive
Arm A: FACActive comparatorFAC X 6 The standard arm consisted of six cycles of FAC (fluorouracil 500 mg/m2, doxorubicin 50mg/m2, and cyclophosphamide 500mg/m2) administered once every 3 weeks.
Receives: Drug: Fluorouracil; Drug: Doxorubicin; Drug: Cyclophosphamide
Arm B: FAC-wPExperimentalFAC X 4 + 8 weekly Paclitaxel (wP) Patients in the experimental arm received four cycles of the FAC regimen followed by eight weekly administrations of paclitaxel (100mg/m2 per dose)
Receives: Drug: Fluorouracil; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Paclitaxel

What is being measured

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

  1. Disease-free Survival (DFS) Event

    DFS is defined as the evidence of local, regional or metastatic recurrence, second primary cancer (with the exception of carcinoma of squamous cells or basal cells of the skin, cervical carcinoma in situ or lobular or ductal carcinoma in situ of the breast) or death for any reason.

    Measured: Up to 5 years

Secondary outcomes (1)

  1. Overall Survival (OS) Event

    OS event is defined as the death from any cause.

    Measured: Up to 5 years

Timeline

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

  1. First posted11 Aug 2005 (estimated)
  2. Study start19 Sep 2003
  3. Primary completion1 Oct 2013
  4. Study completion1 Oct 2013

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
1,925 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129389
Sponsor's protocol ID
GEICAM 2003-02
Other IDs
2005-003109-10, 2005
Status last verified
Mar 2023
First submitted
10 Aug 2005
Last updated
7 Mar 2023
Data monitoring committee
No

Publications

  • Martin M, Ruiz A, Ruiz Borrego M, Barnadas A, Gonzalez S, Calvo L, Margeli Vila M, Anton A, Rodriguez-Lescure A, Segui-Palmer MA, Munoz-Mateu M, Dorca Ribugent J, Lopez-Vega JM, Jara C, Espinosa E, Mendiola Fernandez C, Andres R, Ribelles N, Plazaola A, Sanchez-Rovira P, Salvador Bofill J, Crespo C, Carabantes FJ, Servitja S, Chacon JI, Rodriguez CA, Hernando B, Alvarez I, Carrasco E, Lluch A. Fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus FAC followed by weekly paclitaxel as adjuvant therapy for high-risk, node-negative breast cancer: results from the GEICAM/2003-02 study. J Clin Oncol. 2013 Jul 10;31(20):2593-9. doi: 10.1200/JCO.2012.46.9841. Epub 2013 Jun 3.

    PubMed 23733779

  • Blasco A, Pastor-Barriuso R, Zamora-Aunon P, Martin M, Salvador Bofill J, Reboredo C, Marin M, Barnadas A, Margeli M, Lopez-Vega JM, Lahuerta A, Guerrero A, Servitja S, Alvarez I, Aranda E, Martinez de Duenas E, Carabantes F, Lope V. EORTC QLQ-C30 symptom components and their functional correlates during adjuvant chemotherapy for early breast cancer: a multivariate analysis. Data from GEICAM/2003-02 study. Qual Life Res. 2026 Oct 10;35(11):306. doi: 10.1007/s11136-026-04412-8.

    PubMed 42859303

  • 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 Fluorouracil, Doxorubicin and Cyclophosphamide in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 68 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 21 inclusion and 16 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 7 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 68 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?

Yes. Results are posted in the registry (first posted 12 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (DFS) Event (time frame: Up to 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 NCT00129389, which also lists 3 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 7 Mar 2023.

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