Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Related Publications
Trial Contact Information
Registry Information

Alternate Title

Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Metastatic Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 to 65	NCI	NU-HAC98B2 NCI-G00-1689, NCT00004900

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.

Entry 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

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

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

Expected Enrollment

A total of 50 patients will be accrued for this study.

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.

Pecora AL, Lazarus HM, Stadtmauer EA, et al.: Effect of induction chemotherapy and tandem cycles of high-dose chemotherapy on outcomes in autologous stem cell transplant for metastatic breast cancer. Bone Marrow Transplant 27 (12): 1245-53, 2001.[PUBMED Abstract]

Pecora A, Lazarus H, Stadtmauer E, et al.: Induction chemotherapy prior to sequential high dose chemotherapy compared to no induction increases the rate of complete response and duration of progression free survival in women with metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 18: A-467, 1999.

Pecora AL, Lazarus L, Kramer L, et al.: Phase II multi-institution trial of induction docetaxel and doxorubicin followed by sequential high dose chemotherapy for women with metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 17: A-634, 1998.

Trial Contact Information

Trial Lead Organizations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Andrew Pecora, MD, FACP, Protocol chair		Ph: 201-996-5814 Email: APecora@humed.com

Registry Information
Official Title		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
Trial Start Date		1999-10-28
Registered in ClinicalTrials.gov		NCT00004900
Date Submitted to PDQ		2000-01-13
Information Last Verified		2007-10-24