Neoadjuvant or Adjuvant Epirubicin, Cyclophosphamide, and Paclitaxel in Treating Women With Stage I, Stage II, or Stage III Breast Cancer

NCT00072319 | Completed Phase 2

• 3 other identifiers: 03-092P30CA008748MSKCC-03092
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as epirubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy drugs before surgery may shrink the tumor so that it can be removed during surgery. Giving chemotherapy drugs after surgery may kill any remaining tumor cells. PURPOSE: Pilot trial to study the effectiveness of neoadjuvant or adjuvant epirubicin, cyclophosphamide, and paclitaxel in treating women who have stage I, stage II, or stage III breast cancer.

Conditions

Breast Cancer

Keywords

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

Interventions

filgrastim BIOLOGICAL

cyclophosphamide DRUG

epirubicin hydrochloride DRUG

paclitaxel DRUG

adjuvant therapy PROCEDURE

neoadjuvant therapy PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed adenocarcinoma of the breast * Stage I, II, or III * Inflammatory breast cancer allowed * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 18 and over Sex * Female Menopausal status * Not specified Performance status * ECOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic * Bilirubin normal * SGOT/SGPT no greater than 2.5 times upper limit of normal (ULN) AND alkaline phosphatase no greater than ULN OR * SGOT/SGPT no greater than ULN AND alkaline phosphatase no greater than 4 times ULN Renal * Not specified Cardiovascular * LVEF at least lower limit of normal by MUGA or echocardiogram * No unstable angina * No congestive heart failure * No arrhythmia requiring medical therapy * No myocardial infarction within the past year Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergy/hypersensitivity to any of the study drugs or other drugs formulated with Cremophor EL * No psychiatric illness that would preclude understanding of the nature of the study or study compliance * No active unresolved infection * No peripheral neuropathy greater than grade 1 * No other nonmammary malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or carcinoma in situ of the cervix * No concurrent medical condition that would preclude study participation in the judgment of the investigator PRIOR CONCURRENT THERAPY: Biologic therapy * More than 12 months since prior immunotherapy for prior breast cancer * No prior or concurrent biologic therapy or immunotherapy for this breast cancer Chemotherapy * More than 12 months since prior chemotherapy for prior breast cancer * No prior anthracycline (i.e., doxorubicin or epirubicin) and taxane therapy * No prior or other concurrent chemotherapy for this breast cancer Endocrine therapy * No concurrent hormonal therapy for chemoprevention * Prior hormonal therapy for chemoprevention allowed * No concurrent sex hormonal therapy (e.g., birth control pills or ovarian hormonal replacement therapy) Radiotherapy * No prior radiotherapy * No other concurrent radiotherapy for this breast cancer Surgery * Not specified Other * No concurrent digitalis, beta-blockers, or calcium channel blockers for congestive heart failure

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Pharmacia: collaborator
• Amgen: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

Filgrastim; Cyclophosphamide; Epirubicin; Paclitaxel; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; 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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Monica N. Fornier, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2003
• First Posted: November 6, 2003
• Study Start: August 1, 2003
• Primary Completion: November 1, 2006
• Study Completion: November 1, 2006
• Last Updated: March 4, 2013

Record last verified: 2013-03

Locations

US (1)