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Standard Chemotherapy Compared With High-Dose Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00002755
Recruitment Status : Completed
First Posted : August 24, 2004
Last Update Posted : November 6, 2013
Sponsor:
Information provided by:

Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow doctors to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which treatment regimen is more effective for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of standard cyclophosphamide, methotrexate, and fluorouracil with that of high-dose combination chemotherapy plus peripheral stem cell transplantation in treating women who have stage II or stage IIIA breast cancer.


Condition or disease Intervention/treatment Phase
Breast Cancer Biological: filgrastim Drug: CMF regimen Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: fluorouracil Drug: methotrexate Drug: tamoxifen citrate Drug: thiotepa Procedure: autologous bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy Phase 3

Detailed Description:

OBJECTIVES: I. Compare the efficacy of high dose cyclophosphamide and thiotepa with peripheral blood stem cell support vs conventional cyclophosphamide, methotrexate, and fluorouracil (CMF), both following doxorubicin induction, in women with high risk breast cancer.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by the number of positive axillary nodes (4-9 vs at least 10) and by center. Patients are randomized to one of two treatment arms. Arm I: Patients receive induction therapy consisting of doxorubicin IV every 3 weeks for 4 courses followed by consolidation therapy consisting of cyclophosphamide IV, methotrexate IV, and fluorouracil IV every 3 weeks for 8 courses. At week 4 of consolidation therapy, patients receive radiotherapy to the breast, chest wall, and axilla over 3-5 weeks or as appropriate. Following recovery from consolidation therapy, patients receive maintenance therapy consisting of oral tamoxifen daily for 5 years. Arm II: Patients receive induction therapy as in arm I followed by consolidation therapy consisting of stem cell mobilization with high dose cyclophosphamide IV over 2 hours and filgrastim (G-CSF) subcutaneously beginning 24 hours after cyclophosphamide and continuing until blood counts recover. At 13-28 days following peripheral blood stem cell (PBSC) collection and/or autologous bone marrow collection, patients undergo chemoablation consisting of thiotepa IV and cyclophosphamide IV continuously over 4 days followed 72 hours later by PBSC infusion with or without autologous bone marrow. Following hematologic recovery, patients receive radiotherapy and maintenance therapy as in arm I. Patients are followed every 6 months for 2 years, then annually.

PROJECTED ACCRUAL: More than 600 patients will be accrued for this study over 5 years.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: PROSPECTIVE RANDOMISED EVALUATION OF HIGH-INTENSITY CHEMOTHERAPY WITH PERIPHERAL BLOOD PROGENITOR SUPPORT IN PATIENTS WITH HIGH RISK BREAST CANCER
Study Start Date : November 1995
Study Completion Date : June 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage II or IIIA breast cancer with at least 4 positive axillary nodes Definitive resection required, preferably within 4 weeks prior to entry No overt residual axillary nodal carcinoma after surgery Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Not specified Performance status: ECOG 0 or 1 Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 9 g/dL PT and aPTT normal Hepatic: Bilirubin normal (unless benign congenital hyperbilirubinemia) Normal liver biopsy required in patients with active hepatitis B or C Renal: Creatinine normal Cardiovascular: No active heart disease Normal wall motion on MUGA or echocardiogram Other: Adequate nutritional status (i.e., more than 1,000 calories/day orally) HIV negative No serious medical or psychiatric disease No second malignancy except: Basal cell skin cancer Carinoma in situ of the cervix Not pregnant Negative pregnancy test

PRIOR CONCURRENT THERAPY: At least 2 weeks since major surgery

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00002755


Locations
Ireland
St. Vincent's Hospital
Dublin, Ireland, 4
United Kingdom
Addenbrooke's NHS Trust
Cambridge, England, United Kingdom, CB2 2QQ
Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Royal Free Hospital
Hampstead, London, England, United Kingdom, NW3 2QG
Northwick Park Hospital
Harrow, England, United Kingdom, HA1 3UJ
Huddersfield Royal Infirmary
Huddersfield, West Yorks, England, United Kingdom, HD3 3EA
St. James's Hospital
Leeds, England, United Kingdom, LS9 7TF
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Middlesex Hospital- Meyerstein Institute
London, England, United Kingdom, W1N 8AA
Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom, NG5 1PB
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Weston Park Hospital
Sheffield, England, United Kingdom, S1O 2SJ
Royal South Hants Hospital
Southampton, England, United Kingdom, SO14 0YG
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Royal Infirmary
Edinburgh, Scotland, United Kingdom, EH3 9YW
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 9NQ
Beatson Oncology Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Royal Infirmary
Glasgow, Scotland, United Kingdom, G4 0SF
Velindre Hospital
Cardiff, Wales, United Kingdom, CF4 7XL
Sponsors and Collaborators
Scottish Cancer Therapy Network
Investigators
Study Chair: Robert C.F. Leonard, MD, BS, MB Edinburgh Cancer Centre at Western General Hospital
More Information

ClinicalTrials.gov Identifier: NCT00002755     History of Changes
Other Study ID Numbers: CDR0000064692
SCTN-BR9405
EU-95048
First Posted: August 24, 2004    Key Record Dates
Last Update Posted: November 6, 2013
Last Verified: May 2007

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Methotrexate
Fluorouracil
Thiotepa
Liposomal doxorubicin
Doxorubicin
Tamoxifen
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antimetabolites