Chemotherapy Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer

NCT00003953 | Completed Phase 2 DMC

• 4 other identifiers: CWRU2198P30CA043703CWRU-2198NCI-G99-1537
• Study Type: interventional
• Target: 39
• 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. PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel followed by surgery in treating women who have stage II or stage III breast cancer.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Determine the clinical response of these patients to treatment

  A clinical evaluation of tumor size includes repeat measurements of the palpable tumor in 2 dimensions, repeat mammography, if originally informative, of the affected breast with measurements of the palpable tumor in 2 or 3 dimensions and/or, evaluation of ipsilateral axillary lymph nodes with measurements, if palpable.

  after 3 courses (12 weeks)

• Pathological Response

  Number of patients with a complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). CR is defined as disappearance of lesions. PR is defined as at least a 50% reduction in the sum of lesions. SD is defined as no significant change and PD is defined as the increase in the size of lesions.

  after surgery at 15 weeks

Secondary Outcomes (2)

• Detection of circulating tumor cells

  after surgery at 15 weeks

• Tumor response correlates with HER2/neu expression of the primary tumor.

  baseline

Study Arms (1)

Doxorubicin and Docetaxel

EXPERIMENTAL

Biological: filgrastim; Drug: CMF regimen; Drug: docetaxel; Drug: doxorubicin hydrochloride; Drug: tamoxifen citrate; Procedure: autologous bone marrow transplantation; Procedure: surgical procedure; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each 2 week course.

Doxorubicin and Docetaxel

CMF regimen DRUG

Stratum I and II: receive cyclophosphamide, methotrexate, and fluorouracil (CMF) for 4 courses

Also known as: cyclophosphamide, methotrexate, fluorouracil

Doxorubicin and Docetaxel

docetaxel DRUG

Docetaxel IV over 1 hour on days 43, 57, and 71.

Doxorubicin and Docetaxel

doxorubicin hydrochloride DRUG

Doxorubicin IV on days 1, 15, and 29.

Doxorubicin and Docetaxel

tamoxifen citrate DRUG

Patients with positive estrogen or progesterone receptors receive oral tamoxifen daily for 5 years.

Doxorubicin and Docetaxel

autologous bone marrow transplantation PROCEDURE

Stratum III:may receive high dose chemotherapy with stem cell support

Doxorubicin and Docetaxel

surgical procedure PROCEDURE

Fourteen to 21 days following preoperative chemotherapy, patients undergo a radical, modified radical, or breast sparing surgery plus axillary lymph node dissection.

Doxorubicin and Docetaxel

radiation therapy RADIATION

Radiotherapy is administered 5 days a week for 5.5 weeks.

Doxorubicin and Docetaxel

Eligibility Criteria

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

You may not qualify if:

• Patients with a prior history of malignancy other than those mentioned in section 3.1.12 are ineligible.
• Patients must not have severe concurrent medical or psychiatric illness (i.e. no severe diabetes mellitus, poorly controlled ischemic heart disease or congestive heart failure, or severe chronic obstructive or restrictive pulmonary disease).
• The interval between initial diagnosis of breast cancer and the start of treatment must not be greater than 8 weeks.
• Due to anticipated toxicities to an unborn fetus, and excretion of chemotherapy in breast milk, patients must not be pregnant or lactating and must use effective contraception during treatment.
• No history of hypersensitivity reaction to preparation containing polysorbate 80, 3.2.6 Patients must not have peripheral neuropathy grade 2 or higher.
• Patients must not have had prior radiation to \>25% of bone marrow

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Metro Health Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; CMF regimen; Cyclophosphamide; Methotrexate; Fluorouracil; Docetaxel; Doxorubicin; Tamoxifen; Surgical Procedures, Operative; Radiotherapy

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; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Therapeutics

Study Officials

• Brenda W. Cooper, MD

  Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

  STUDY CHAIR

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: November 1, 1999
• First Posted: April 28, 2004
• Study Start: February 1, 1999
• Primary Completion: November 1, 2001
• Study Completion: January 1, 2013
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

US (2)