Combination Chemotherapy in Treating Women With Breast Cancer

NCT00047099 | Completed Phase 3

• 2 other identifiers: LMU-ADEBAREU-20221
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells following surgery. It is not yet known which combination chemotherapy regimen is more effective in treating breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two different combination chemotherapy regimens in treating women who have primary breast cancer.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (1)

• Comparison of time to progression

Secondary Outcomes (3)

• Overall survival time

• Toxicity

• Changes in quality of life over time as measured by the EORTC QLQ-C30 and BR23 questionnaires

Interventions

cyclophosphamide DRUG

docetaxel DRUG

epirubicin hydrochloride DRUG

fluorouracil DRUG

goserelin acetate DRUG

tamoxifen citrate DRUG

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Diagnosis of primary epithelial invasive carcinoma of the breast * T1-4, N1-2, M0 * Must have 4 metastatic axillary lymph nodes * Complete resection of the primary tumor within the past 5 weeks * Free of invasive carcinoma with at least 10 lymph nodes removed * No inflammatory breast cancer * No distant metastases by chest x-ray, liver ultrasound, and whole body bone scan * Hormone receptor status: * Estrogen and/or progesterone receptor status known PATIENT CHARACTERISTICS: Age * 18 to 70 Sex * Female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * At least 32 weeks Hematopoietic * WBC at least 3,000/mm3 * Platelet count at least 100,000 Hepatic * Bilirubin no greater than 1.5 times upper limit of normal (ULN) * SGOT/SGPT no greater than 1.5 times ULN * Alkaline phosphatase no greater than 1.5 times ULN * Albumin no greater than 1.5 times ULN Renal * Creatinine no greater than 1.5 times ULN Cardiovascular * No cardiomyopathy with impaired ventricular function * No New York Heart Association class III or IV heart disease * No cardiac arrhythmias influencing LVEF and requiring medication * No myocardial infarction within the past 6 months * No angina pectoris within the past 6 months * No uncontrolled arterial hypertension Other * No other primary malignancy except carcinoma in situ of the cervix or adequately treated basal cell skin cancer * No known hypersensitivity to docetaxel, epirubicin, fluorouracil, cyclophosphamide, or other study medication * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior cytotoxic or other antineoplastic therapy * No other concurrent cytotoxic or other antineoplastic therapy Endocrine therapy * Not specified Radiotherapy * No prior radiotherapy Surgery * See Disease Characteristics Other * At least 3 weeks since prior investigational agents

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

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (2)

I. Frauenklinik und Hebammenschule der Ludwig-Maximillians Universitaet Muenchen

Munich, D-80337, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Related Publications (3)

• Janni JW, Sommer H, Rack B, et al.: The ADEBAR trial: final toxicity analysis of a phase III study evaluating the role of docetaxel in the adjuvant therapy of breast cancer patients with extensive lymph node involvement. [Abstract] J Clin Oncol 25 (Suppl 18): A-585, 24s, 2007.

  RESULT

• Gauger K, Bismarck FV, Heinrigs M, et al.: Phase III study evaluating the role of docetaxel in the adjuvant setting of breast cancer patients with = 4 involved lymph nodes: ADEBAR study. [Abstract] J Clin Oncol 23 (Suppl 16): A-908, 104s, 2005.

  RESULT

• Sommer HL, Janni W, Rack B, et al.: The ADEBAR-trial: the sequencing of regional radiotherapy and chemotherapy does not influence cytostatic dose intensity. [Abstract] J Clin Oncol 23 (Suppl 16): A-744, 64s, 2005.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Epirubicin; Fluorouracil; Goserelin; Tamoxifen; Chemotherapy, Adjuvant; Radiotherapy

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Harald Sommer, MD

  Ludwig-Maximilians - University of Munich

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: October 3, 2002
• First Posted: January 27, 2003
• Study Start: August 1, 2001
• Primary Completion: February 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 30, 2013

Record last verified: 2002-12

Locations

DE (2)