NCT00002942

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 autologous bone marrow transplantation or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Randomized phase III trial to compare bone marrow transplantation with peripheral stem cell transplantation following carboplatin in treating patients with breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at below P25 for phase_3 breast-cancer

Timeline
Completed

Started Jun 1996

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1996

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2000

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 3, 2004

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

3.6 years

First QC Date

November 1, 1999

Last Update Submit

August 8, 2018

Conditions

Breast Cancer

Keywords

stage II breast cancerstage IV breast cancerstage IIIA breast cancerstage IIIB breast cancer

Study Arms (2)

Peripheral Blood Progenitor Cells

ACTIVE COMPARATOR
Procedure: peripheral blood stem cell transplantation

Autologous Bone Marrow Collection

EXPERIMENTAL
Procedure: autologous bone marrow transplantation

Interventions

autologous bone marrow transplantationPROCEDURE
Autologous Bone Marrow Collection
peripheral blood stem cell transplantationPROCEDURE
Peripheral Blood Progenitor Cells

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: Histologically confirmed Stage IIIB and IV adenocarcinoma of the breast Stage II-IIIA adenocarcinoma of the breast with poor risk features (including poorly differentiated histology, high mitotic rate, hormone receptor negative, high S phase) with at least three involved axillary lymph nodes, estimated five year relapse free survival rate less than 50%, and does not qualify for higher priority protocol treatments No central nervous system involvement PATIENT CHARACTERISTICS: Age: 18 to 60 Performance status: Karnofsky 80-100% Life expectancy: Greater than 2 months Hematopoietic: Platelet count greater than 75,000/mm3 Neutrophils greater than 1500/mm3 Hepatic: Serum bilirubin, alkaline phosphatase, and SGOT or SGPT less than 3 times upper limit of normal, unless due to disease Renal: Serum creatinine less than 1.5 times upper limit of normal Creatinine clearance at least 60 mL.min Cardiovascular: Ventricular ejection fraction at least 45% No uncontrolled or severe cardiovascular disease, including recent myocardial infarction, congestive heart failure, angina, life threatening arrhythmia, or hypertension Pulmonary: DLCO and spirometry at least 50% of predicted Other: Not HIV positive Not HBsAG positive Not pregnant Must have functioning central venous catheter No active infection No uncontrolled diabetes mellitus No other prior malignancy except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for at least 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: No prior hematopoietic progenitor cell support Chemotherapy: No prior dose intensive therapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157-1082, United States

Location

Related Publications (1)

  • Acostamadiedo J, Case D, Perry J, et al.: Randomized trial of G-CSF primed (G') autologous bone marrow (ABM) vs. G' peripheral blood stem cells (PBSC) as hematopoietic support after high-dose cyclophosphamide (C) thiotepa (T), and carboplatin (CB) (CTCB) in poor prognosis breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 19: A215, 56a, 2000.

    RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • David D. Hurd, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

September 3, 2004

Study Start

June 1, 1996

Primary Completion

January 1, 2000

Study Completion

December 1, 2003

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(1)