Cyclophosphamide, Methotrexate, and Fluorouracil, With or Without Epirubicin Hydrochloride, in Treating Women Who Have Undergone Surgery for Breast Cancer (Group III Closed to New Patients as of 12/7/2009)

NCT01031030 | Unknown Phase 3

• 2 other identifiers: IRST-IBIS-03CDR0000661068
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, fluorouracil, and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving cyclophosphamide together with methotrexate and fluorouracil before, after, or without epirubicin hydrochloride is more effective in treating patients with breast cancer that can be removed by surgery. PURPOSE: This randomized phase III trial is comparing three regimens of cyclophosphamide given together with methotrexate and fluorouracil, with or without epirubicin hydrochloride, to see how well it works in treating women who have undergone surgery for breast cancer. (Group III was closed to new patients as of 12/7/2009.)

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (4)

• Disease-free survival

• Toxicity

• Quality of life

• Efficacy in subgroups of patients

Interventions

cyclophosphamide DRUG

epirubicin hydrochloride DRUG

fluorouracil DRUG

methotrexate DRUG

laboratory biomarker analysis OTHER

adjuvant therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed breast cancer * Underwent radical mastectomy, guadrantectomy, or tumorectomy with axillary node dissection within the past 4-6 weeks * Biologically aggressive disease * At least 10 lymph nodes removed * Node-negative (\> 1 cm, or \> 2 cm if histology is favorable, esp. tubular carcinoma and/or prevalent intraductal component \> 50%) tumors OR node-positive (1-3) tumors, meeting the following criteria: * High thymidine-labeling index (\> 3%) * Poorly differentiated tumor (grade III) * High S-phase fraction (\> 10% by flow cytometry) * High Ki67/MIB1 expression (\< 20%) * No bilateral breast cancer * No T4a, inoperable T4b, T4c, or T4d disease * Any estrogen receptor status (positive, negative, unknown) * No distant metastases PATIENT CHARACTERISTICS: * Any menopause status * WBC ≥ 3,500/mL * ANC ≥ 1,500/mL * Platelet count ≥ 120,000/mL * AST and ALT ≤ 1.5 times upper limit of normal (ULN) * Creatinine ≤ 1.5 mg/mL * Bilirubin ≤ 1.5 times ULN * Not pregnant * Geographically accessible for follow-up * No prior breast cancer and/or other cancer except for carcinoma in situ of the cervix or basal cell skin cancer treated with radical intent * No significant alterations in cardiovascular function * No serious psychiatric disorders * No impaired renal or liver function PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS: lead

Related Publications (1)

• Farolfi A, Scarpi E, Rocca A, Mangia A, Biglia N, Gianni L, Tienghi A, Valerio MR, Gasparini G, Amaducci L, Faedi M, Baldini E, Rubagotti A, Maltoni R, Paradiso A, Amadori D. Time to initiation of adjuvant chemotherapy in patients with rapidly proliferating early breast cancer. Eur J Cancer. 2015 Sep;51(14):1874-81. doi: 10.1016/j.ejca.2015.07.003. Epub 2015 Jul 20.

  PMID: 26206258 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Epirubicin; Fluorouracil; Methotrexate; Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Dino Amadori, MD

  Morgagni-Pierantoni Ospedale

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 11, 2009
• First Posted: December 14, 2009
• Study Start: November 1, 1997
• Primary Completion: December 1, 2010
• Last Updated: August 2, 2013

Record last verified: 2009-12