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

NCT00004900 | Completed Phase 2

• 3 other identifiers: NU-HAC98B2CDR0000067579NCI-G00-1689
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus peripheral stem cell transplantation in treating women who have metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer; stage IIIB breast cancer

Interventions

filgrastim BIOLOGICAL

anastrozole DRUG

carboplatin DRUG

cisplatin DRUG

cyclophosphamide DRUG

etoposide DRUG

thiotepa DRUG

peripheral blood stem cell transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (3)

• Pecora AL, Lazarus HM, Stadtmauer EA, Winter J, Van Vliet A, Berry D, Gray R, Jennis A, Goldberg S, Cooper BW, Preti R. 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. 2001 Jun;27(12):1245-53. doi: 10.1038/sj.bmt.1703066.

  PMID: 11548842 BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; Anastrozole; Carboplatin; Cisplatin; Cyclophosphamide; Etoposide; Thiotepa; Peripheral Blood Stem Cell Transplantation; 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; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Triethylenephosphoramide; Aziridines; Azirines; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Andrew L. Pecora, MD, FACP

  Hackensack University Medical Center Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: August 20, 2004
• Study Start: October 1, 1999
• Study Completion: August 1, 2004
• Last Updated: May 30, 2013

Record last verified: 2007-10

Locations

US (1)