Study on Chemotherapy and Stem Cell Transplantation for Treating Stage IIIB Breast Cancer

Sponsor: City of Hope Medical Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT00003042

Provider View

This clinical trial is exploring how well a combination of chemotherapy and stem cell transplantation works in treating patients with stage IIIB breast cancer. The study aims to see if this approach can improve treatment outcomes by allowing higher doses of chemotherapy to be used.

Patient Parameters

Program Overview

The purpose of this study is to find out if using chemotherapy along with stem cell transplantation can effectively treat patients with stage IIIB breast cancer. Chemotherapy drugs work by stopping cancer cells from growing and dividing. By combining chemotherapy with stem cell transplantation, doctors hope to use higher doses of chemotherapy to kill more cancer cells.

Description

This study is designed to evaluate the effectiveness of a treatment plan that includes intensive chemotherapy, surgery, and stem cell transplantation for patients with stage IIIB breast cancer. The main goals are to see how well this treatment can reduce cancer, prevent it from coming back, and improve survival rates.

Patients are divided into two groups based on their previous chemotherapy treatments. The first group receives a series of chemotherapy drugs over several weeks, followed by surgery to remove the cancer. After surgery, both groups receive additional chemotherapy and have their stem cells collected for later use.

The next phase involves high-dose chemotherapy, where patients receive strong doses of chemotherapy drugs to target any remaining cancer cells. Stem cells collected earlier are then reintroduced to help the body recover from the intense treatment.

Radiation therapy is given a few weeks after the high-dose chemotherapy, and patients with certain types of tumors may also receive a medication called tamoxifen.

Participants will be monitored closely, with follow-up visits every three months for the first two years and then annually for the next three years. The study plans to enroll about 60 patients over four years.

Eligibility Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven stage IIIB breast cancer with dermal/epidermal invasion or clinical features of inflammation, erythema, pain or hypersensitivity, edema, or thickening of the skin
  • Diagnosis within the past 6 months

PATIENT CHARACTERISTICS:

Age:

  • 60 and under

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin less than 1.5 mg/dL
  • SGOT or SGPT no greater than 1.5 times the upper limit of normal

Renal:

  • Creatinine less than 1.2 mg/dL
  • Creatinine clearance at least 80 mL/min
  • No history of hemorrhagic cystitis

Cardiovascular:

  • Left ventricular fraction at least 55% on MUGA scan
  • No previous valvular heart disease or arrhythmia

Pulmonary:

  • FEV_1 at least 60% predicted
  • Room air pO_2 greater than 85 mmHg
  • Room air pCO_2 no greater than 43 mmHg
  • DLCO at least 60% of the lower limit of predicted value

Other:

  • No history of malignant disease in the past 5 years, except for squamous or basal cell skin cancer and stage I or in situ cervical cancer
  • No organic CNS dysfunction
  • Not pregnant
  • No known and potentially disabling psychosocial history
  • Not positive for hepatitis B or HIV

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Stratum 1:

    • No more than one cycle of chemotherapy

  • Stratum 2:

    • No greater than 225 mg/m^2 doxorubicin and no greater than 250 mg/m^2 paclitaxel during previous chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiation to the left chest wall

Surgery:

  • Modified radical mastectomy allowed

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