Breast Cancer Metastatic
A Phase II Multi-Institution 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
Objectives:
1. To assess the toxicity and response rates to sequential high dose chemotherapy without induction chemotherapy in metastatic breast cancer patients.
2. To determine the hematopoietic recovery rate after infusion of blood derived
CD 34+ progenitors isolated using a CD 34+ affinity device.
3. To compare response rates and duration of responses between metastatic breast cancer patients treated in this trial without conventional dose induction chemotherapy to patients treated in a previous trial using the same sequential high dose chemotherapy with induction conventional dose chemotherapy.
Treatment:
1. Mobilization phase:
* Cyclophosphamide
* Etoposide
* Cisplatin
* GCSF
2. Stamp V phase:
* Cyclophosphamide
* Thiotepa
* Carboplatin
* GCSF
Eligibility:
INITIAL INCLUSION / EXCLUSION:
1. Females >= 18 and <= 65 years old.
2. Patients with histologically documented epithelial carcinoma of the breast metastatic to any organ (except Brain), including ipsilateral supraclavicular
(not axillary) lymph nodes and chest wall.
3. Must have biological and / or immunocytochemical receptor assays for estrogen and progesterone reported.
4. ECOG performance status of 0, 1, or 2.
5. WBC > 3000/ul, platelet count > 100,000/ul, serum total bilirubin < 3.0 mg/dl,
and SGOT <= 6 x upper limit of normal.
6. Ejection fraction by radionuclide cardiac scan (MUGA) >= 40%.
7. No active infection or medical condition which would preclude administration of high dose therapy.
8. Must have evaluable (bone only) or measureable disease on exam or radiologic studies.
9. Patients may have received a course of prior adjuvant therapy but not within 6 months of entry onto study. Patients may also have received prior hormone therapy for metastatic disease.
|