A Phase II Pilot Study of Sequential High Dose Chemotherapy and CD 34+ Selected Stem Cell Support Without Conventional-Dose Induction Chemotherapy for Women With Metastatic Breast Cancer
filgrastim
+ anastrozole
+ carboplatin
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.OBJECTIVES: I. Assess the toxicity and response rates to sequential high dose chemotherapy without induction chemotherapy in women with metastatic breast cancer. II. Determine the hematopoietic recovery rate in these patients after infusion of blood derived CD34+ progenitors isolated using a CD34+ affinity device for positive purification of the autograft. III. Compare response rates and duration of responses between these patients treated in this trial to patients treated in a previous trial using the same sequential high dose chemotherapy with induction conventional dose chemotherapy. OUTLINE: Patients receive cyclophosphamide IV daily for 2 days, and etoposide IV and cisplatin IV daily for 3 days. Filgrastim (G-CSF) is administered subcutaneously twice daily beginning 24 hours after completion of chemotherapy until the last day of apheresis. Upon hematopoietic recovery, peripheral blood stem cells (PBSC) are collected over several days. Within 35 days of mobilization chemotherapy, patients receive cyclophosphamide IV, thiotepa IV, and carboplatin IV continuously on days -7 to -4, followed by a 2 day rest period. CD34+ selected PBSC are reinfused. Beginning 4 hours after reinfusion, patients receive G-CSF subcutaneously daily until hematopoietic recovery. Patients may then receive radiation therapy to sites of prior bulk disease at the discretion of the investigator. Within 30 days of hematopoietic recovery or immediately following post transplant radiation therapy, patients receive oral anastrazole daily until disease progression. Patients are followed monthly for 6 months, every 3 months for 1 year, every 4-6 months for 5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically confirmed epithelial carcinoma of the breast metastatic to any organ except brain, including ipsilateral supraclavicular (not axillary) lymph nodes and chest wall No apocrine, adenocystic, squamous cell carcinoma, sarcoma, or lymphoma Measurable or evaluable disease No stage IV disease rendered nonassessable by surgery No symptomatic CNS disease Hormone receptor status: Must have biological and/or immunocytochemical receptor assays for estrogen and progesterone reported PATIENT CHARACTERISTICS: Age: 18 to 65 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 3.0 mg/dL SGOT no greater than 6 times upper limit of normal Renal: Not specified Cardiovascular: Ejection fraction at least 40% by MUGA No angina pectoris requiring active nitrate therapy No myocardial infarction within the past 6 months No uncontrolled congestive heart failure, uncontrolled hypertension, or major ventricular arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active infection or medical condition that would preclude administration of high dose therapy No other prior malignancy within the past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix No uncompensated endocrine dysfunction HIV negative Hepatitis B negative PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior course of adjuvant therapy No other prior chemotherapy for metastatic breast cancer At least 6 months since prior adjuvant therapy No cumulative doxorubicin equivalent dose or greater than 360 mg/m2 in the adjuvant setting Endocrine therapy: Prior hormonal therapy for metastatic disease allowed Radiotherapy: Not specified Surgery: See Disease Characteristics
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center, Northwestern University in Google Maps