FAC Versus FAC Plus Weekly Paclitaxel as Adjuvant Treatment of Node Negative High Risk Breast Cancer Patients
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
2 other identifiers
interventional
1,925
1 country
68
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Sep 2003
Longer than P75 for phase_3 breast-cancer
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2003
CompletedFirst Submitted
Initial submission to the registry
August 10, 2005
CompletedFirst Posted
Study publicly available on registry
August 11, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedResults Posted
Study results publicly available
July 12, 2019
CompletedMarch 7, 2023
March 1, 2023
10 years
August 10, 2005
January 25, 2019
March 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Up to 5 years
Secondary Outcomes (1)
Overall Survival (OS) Event
Up to 5 years
Study Arms (2)
Arm A: FAC
ACTIVE 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.
Arm B: FAC-wP
EXPERIMENTALFAC 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)
Interventions
Eligibility Criteria
You may qualify if:
- 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.
- 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):
- +6 more criteria
You may not qualify if:
- 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.
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Spanish Breast Cancer Research Grouplead
- Bristol-Myers Squibbcollaborator
Study Sites (68)
Hospital General Univ. De Elche
Elche, Alicante, 3203, Spain
Hospital General de Elda
Elda, Alicante, 3600, Spain
Complejo Hospitalario de Manresa
Manresa, Barcelona, 8243, Spain
Consorci Sanitari Parc Tauli
Sabadell, Barcelona, 8208, Spain
Hospital del Espíritu Santo
Santa Coloma de Gramenet, Barcelona, 8923, Spain
Consorci Sanitari Terrassa
Terrassa, Barcelona, 8221, Spain
Hospital Mutua Terrassa
Terrassa, Barcelona, 8221, Spain
Hospital General Jerez de la Frontera
Jerez de la Frontera, Cadiz, 11407, Spain
Hospital Provincial de Castellón
Castellon, Castellón, 12002, Spain
Hospital Comarcal de Barbastro
Barbastro, Huesca, 22300, Spain
Hospital Insular de Gran Canaria
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Fundación Hospital de Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Madrid- Montepríncipe
Boadilla del Monte, Madrid, 28660, Spain
Hospital de Móstoles
Móstoles, Madrid, 28935, Spain
Hospital Virgen de la Arrixaca
El Palmar, Murcia, 30120, Spain
Hospital Policlínico Vigo POVISA
Vigo, Pontevedra, 36211, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320, Spain
Hospital Sant Joan de Reus
Reus, Tarragona, 43201, Spain
Hospital de la Ribera
Alzira, Valencia, 46600, Spain
Complejo Hospitalario Juan Canalejo
A Coruña, 15006, Spain
Centro Oncológico de Galicia
A Coruña, 15009, Spain
Complejo Hospitalario de Albacete
Albacete, 2066, Spain
Hospital General Universitario de Alicante
Alicante, 3010, Spain
Hospital Virgen de los Lirios
Alicante, 3804, Spain
Hospital Germans Trias i Pujol
Badalona, 8916, Spain
Hospital del Mar
Barcelona, 8003, Spain
Clínica Corochan S.A.
Barcelona, 8017, Spain
Hospital Clinic i Provincial
Barcelona, 8036, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 8041, Spain
Hospital General de Vic
Barcelona, 8500, Spain
Hospital de Basurto
Bilbao, 48013, Spain
Hospital General Yagüe
Burgos, 9005, Spain
Hospital Puerta del Mar
Cadiz, 11009, Spain
Hospital General de Ciudad Real
Ciudad Real, 13005, Spain
Hospital Reina Sofía
Córdoba, 14004, Spain
Hospital Virgen de la Luz
Cuenca, 16002, Spain
ICO Hospital Universitari Josep Trueta
Girona, 17007, Spain
Hospital General de Guadalajara
Guadalajara, 19002, Spain
Complejo Hospitalario de Jaén
Jaén, 23007, Spain
Hospital Xeral Calde
Lugo, 27004, Spain
Hospital Universitario La Princesa
Madrid, 28006, Spain
Hospital Doce de Octubre
Madrid, 28021, Spain
Hospital Ramón y Cajal
Madrid, 28034, Spain
Hospital Ruber Internacional
Madrid, 28034, Spain
Hospital Puerta de Hierro
Madrid, 28035, Spain
Hospital Clínico San Carlos
Madrid, 28040, Spain
Hospital La Paz
Madrid, 28046, Spain
CIOCC Hospital Norte-Sanchinarro
Madrid, 28050, Spain
Complejo Hospitalario Virgen de la Victoria
Málaga, 29010, Spain
Hospital Carlos Haya
Málaga, 29010, Spain
Hospital Morales Messeguer
Murcia, 30008, Spain
Hospital Sta María Nai
Ourense, 32005, Spain
Hospital General Río Carrión
Palencia, 34005, Spain
Hospital Clínico Universitario de Salamanca
Salamanca, 37007, Spain
Instituto Oncológico de Guipuzcoa
San Sebastián, 20012, Spain
Hospital de Donostia
San Sebastián, 20014, Spain
Hospital Universitario Marqués de Valdecilla
Santander, 39008, Spain
Hospital Univ. Virgen del Rocío
Seville, 41013, Spain
Hospital Universitario de Valme
Seville, 41014, Spain
Hospital Virgen de la Salud
Toledo, 45004, Spain
Hospital Universitario La Fe
Valencia, 46009, Spain
Instituto Valenciano de Oncología
Valencia, 46009, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Arnau de Vilanova
Valencia, 46015, Spain
Hospital Txagorritxu
Vitoria-Gasteiz, 1009, Spain
Hospital Provincial de Zamora
Zamora, 49021, Spain
Hospital Lozano Blesa
Zaragoza, 50009, Spain
Hospital Miguel Servet
Zaragoza, 50009, Spain
Related Publications (1)
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.
PMID: 23733779RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Scientific Director / Medical Lead / Project Manager
- Organization
- Spanish Breast Cancer Research Group
Study Officials
- STUDY DIRECTOR
Study Director
Hospital Universitario San Carlos
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2005
First Posted
August 11, 2005
Study Start
September 19, 2003
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
March 7, 2023
Results First Posted
July 12, 2019
Record last verified: 2023-03