Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer

NCT00005800 | Completed Phase 2

• 2 other identifiers: MCC-11971CA 82533
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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 may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel in treating women who have stage III breast cancer.

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIB breast cancer; inflammatory breast cancer

Outcome Measures

Primary Outcomes (1)

• Pathological Response Rate

  Evaluate the pathological response rate of sequential doxorubicin and docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast cancer. Pathologic response is classified as either complete pathologic response or partial pathologic response based on the size of residual tumor after treatment (complete pathologic response if 0 cm, partial pathologic response if \>0 cm).

  7 years

Study Arms (1)

Dose-Dense Chemotherapy

EXPERIMENTAL

Patients receive doxorubicin IV on day 1 every 2 weeks for 3 courses. After 3 weeks of rest, patients receive docetaxel IV over 1 hour on day 1 every 2 weeks for 3 courses. Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each doxorubicin and docetaxel course. Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection.

Biological: Filgrastim; Drug: Docetaxel; Drug: Doxorubicin; Procedure: Surgery

Interventions

Filgrastim BIOLOGICAL

Also known as: G-CSF

Dose-Dense Chemotherapy

Docetaxel DRUG

Also known as: Taxotere®

Dose-Dense Chemotherapy

Doxorubicin DRUG

Also known as: doxorubicin hydrochloride, Adriamycin, Rubex

Dose-Dense Chemotherapy

Surgery PROCEDURE

Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection.

Dose-Dense Chemotherapy

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or pathologically confirmed stage III breast cancer * Clinical evidence of primary invasive breast tumor greater than 5 cm in dimension (T3) and no evidence of metastatic disease clinically or by staging studies including computed tomography (CT) scan of the chest, abdomen, and pelvis, and a bone scan * Inflammatory breast carcinoma defined as diffuse brawny induration of the skin of the breast with an erysipeloid edge due to embolization of the dermal lymphatics and pathologic evidence of dermal lymphatic invasion * No bilateral breast cancer unless synchronous * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 to 70 Sex: * Female Menopausal status: * Not specified Performance status: * Eastern Cooperative Oncology Group (ECOG) 0-1 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,000/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT/SGPT less than 1.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 4 times ULN provided SGOT/SGPT no greater than ULN Renal: * Creatinine no greater than 1.5 mg/dL Cardiovascular: * If prior cardiac event or ischemia on electrocardiogram, must be cleared by cardiologist * LVEF at least 50% by resting MUGA * No severe cardiac dysfunction * No prior or concurrent angina pectoris, congestive heart failure, or major ventricular arrhythmias * No uncontrolled essential hypertension Other: * Not pregnant or nursing * Fertile patients must use effective nonhormonal barrier contraception * No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma in situ of the breast * No other serious medical or psychiatric illness that would preclude study consent or treatment * No prior severe and intolerable reactions to filgrastim (G-CSF) PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy to the breast Surgery: * Not specified

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

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; Docetaxel; Doxorubicin; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides

Study Officials

• Susan Minton, D.O.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2000
• First Posted: October 8, 2003
• Study Start: April 1, 1999
• Primary Completion: January 1, 2006
• Study Completion: May 1, 2012
• Last Updated: September 25, 2012

Record last verified: 2012-09

Locations

US (1)