Docetaxel, Doxorubicin (A), Cyclophosphamide (C) (TAC) vs 5-Fluorouracil, A, C (5FAC) Breast Cancer Adjuvant Treatment

NCT00121992 | Completed Phase 3 Results

• 2 other identifiers: GEICAM 9805TAX.ES1.301
• Study Type: interventional
• Target: 1,060
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, non-blinded randomized phase III trial. Patients will be post-surgically stratified at inclusion first according to the participating institution, then according to menopausal status and will be randomly assigned to receive either:

• TAC: Docetaxel 75 mg/m2 as a 1 hour intravenous (i.v.) infusion on day 1 every 3 weeks (q3w) in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.
• FAC: 5-fluorouracil 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks in combination with doxorubicin 50 mg/m2 as an i.v. bolus and cyclophosphamide 500 mg/m2 as an i.v. bolus on day 1 every 3 weeks.

Conditions

Breast Neoplasms

Keywords

High risk node negative breast cancer; Disease-Free survival; Quality of life

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival (DFS) Events

  DFS is calculated from the date of randomization until the first date of recurrence local, regional or distant, second primary tumor or death.

  10 years

Secondary Outcomes (7)

• Overall Survival (OS)

  10 years

• The Number of Participants Who Experienced Adverse Events (AE)

  Through study treatment, and average of 4 months

• Best Score During Study for Global Health Status Scale

  120 weeks

• Number of Disease Free Survival Events in Hormone-receptor Positive and Human Epidermal Growth Factor Receptor 2 (HER2) Positive Status Subgroup

  10 year

• Disease Free Survival in Hormonal Receptor Positive and HER2 Negative Subgroup

  10 year

Study Arms (2)

Arm A: FAC

ACTIVE COMPARATOR

FAC (5-fluorouracil, doxorubicin, cyclophosphamide): 5-fluorouracil 500 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv

Drug: 5-fluorouracil; Drug: Doxorubicin; Drug: Cyclophosphamide

Arm B: TAC

EXPERIMENTAL

TAC (docetaxel, doxorubicin, cyclophosphamide): Docetaxel 75 mg/m2 iv on day 1, each 3 weeks, in combination with doxorubicin 50 mg/m2 iv and cyclophosphamide 500 mg/m2 iv

Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide

Interventions

Docetaxel DRUG

Also known as: Taxotere

Arm B: TAC

5-fluorouracil DRUG

Also known as: Adrucil

Arm A: FAC

Doxorubicin DRUG

Also known as: adriamycin

Arm A: FAC; Arm B: TAC

Cyclophosphamide DRUG

Also known as: cytoxan

Arm A: FAC; Arm B: TAC

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Operable breast cancer patients (T1-T3) with negative axillary lymph nodes (10 axillary nodes dissection) and high risk criteria according to St. Gallen consensus criteria.
• Histologically proven breast cancer. Interval between surgery and registration is less than 60 days.
• Definitive surgical treatment must be either mastectomy, or breast conservative surgery. Margins of resected specimen from surgery must be histologically free of invasive adenocarcinoma and ductal carcinoma in-situ (DCIS). Lobular carcinoma in-situ is not considered as positive margin.
• Patients without proven metastatic disease.
• Estrogen and progesterone receptors performed on the primary tumour prior to randomization.
• Age between 18 years and 70 years.
• Karnofsky performance status index \> 80 %.
• Adequate hepatic, renal and heart functions.
• Adequate hematology levels.
• Negative pregnancy test

You may not qualify if:

• Prior systemic anticancer therapy for breast cancer (immunotherapy, hormonotherapy, chemotherapy).
• Prior anthracycline therapy or taxoids (paclitaxel, docetaxel) for any malignancy.
• Prior radiation therapy for breast cancer.
• Bilateral invasive breast cancer.
• Pregnant, or lactating patients.
• Patients of childbearing potential must implement adequate non-hormonal contraceptive measures during study treatment .
• Any T4 or N1-3 or M1 breast cancer.
• Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI criteria.
• Other serious illness or medical condition
• Past or current history of neoplasm other than breast carcinoma.
• Ipsilateral ductal carcinoma in-situ (DCIS) of the breast.
• Lobular carcinoma in-situ (LCIS) of the breast.
• Chronic treatment with corticosteroids unless initiated \> 6 months prior to study entry and at low dose
• Concurrent treatment with ovarian hormonal replacement therapy. Prior treatment should be stopped before study entry.
• Definite contraindications for the use of corticosteroids.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Sanofi: collaborator

Study Sites (1)

Spanish Breast Cancer Research Group

San Sebastián de los Reyes, Madrid, 28700, Spain

Location

Related Publications (2)

• Martin M, Pienkowski T, Mackey J, Pawlicki M, Guastalla JP, Weaver C, Tomiak E, Al-Tweigeri T, Chap L, Juhos E, Guevin R, Howell A, Fornander T, Hainsworth J, Coleman R, Vinholes J, Modiano M, Pinter T, Tang SC, Colwell B, Prady C, Provencher L, Walde D, Rodriguez-Lescure A, Hugh J, Loret C, Rupin M, Blitz S, Jacobs P, Murawsky M, Riva A, Vogel C; Breast Cancer International Research Group 001 Investigators. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005 Jun 2;352(22):2302-13. doi: 10.1056/NEJMoa043681.

  PMID: 15930421 BACKGROUND

• Martin M, Segui MA, Anton A, Ruiz A, Ramos M, Adrover E, Aranda I, Rodriguez-Lescure A, Grosse R, Calvo L, Barnadas A, Isla D, Martinez del Prado P, Ruiz Borrego M, Zaluski J, Arcusa A, Munoz M, Lopez Vega JM, Mel JR, Munarriz B, Llorca C, Jara C, Alba E, Florian J, Li J, Lopez Garcia-Asenjo JA, Saez A, Rios MJ, Almenar S, Peiro G, Lluch A; GEICAM 9805 Investigators. Adjuvant docetaxel for high-risk, node-negative breast cancer. N Engl J Med. 2010 Dec 2;363(23):2200-10. doi: 10.1056/NEJMoa0910320.

  PMID: 21121833 RESULT

Related Links

• home page of the Spanish Breast Cancer Research Group

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Fluorouracil; Doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Scientific Director / Medical Lead / Project Manager
• Organization: Spanish Breast Cancer Research Group

geicam@geicam.org

+34916592870

Study Officials

• Study Director

  Hospital Universitario San Carlos

  STUDY DIRECTOR

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: July 18, 2005
• First Posted: July 21, 2005
• Study Start: July 1, 1999
• Primary Completion: December 2, 2010
• Study Completion: March 6, 2013
• Last Updated: April 4, 2023
• Results First Posted: December 4, 2020

Record last verified: 2023-04

Locations

ES (1)