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High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer Clinical research trials and High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer. High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "H" Clinical Trials Conditions > High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer  High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
For Condition: stage 4 breast cancer,Quality of Life,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): Federation Nationale des Centres de Lutte Contre le Cancer ,
Synopsis: 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 to kill more tumor cells. It is not yet known if high dose chemotherapy plus peripheral stem cell transplantation is more effective than standard therapy for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of high dose chemotherapy plus peripheral stem cell transplantation with that of standard therapy in treating women who have locally recurrent or metastatic breast cancer.
Details: OBJECTIVES: I. Evaluate the effect on 3-year survival of intensive chemotherapy with cyclophosphamide/thiotepa with peripheral blood stem cell rescue in patients with locally recurrent or metastatic breast cancer who respond to induction therapy with epirubicin/fluorouracil/cyclophosphamide. II. Evaluate the effects of this intensive treatment on patient quality of life. III. Evaluate tumor response and progression-free survival after intensification. PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by clinical/therapeutic hormone sensitivity and participating institution. All patients receive induction therapy with epirubicin, fluorouracil, and cyclophosphamide (FEC 100) every 3 weeks for up to 4 courses, with response evaluated after at least 2 courses. Patients with a complete response or at least a 50% partial response are randomized either to no further therapy or to receive intensification chemotherapy. Patients randomized to intensification undergo peripheral blood stem cell (PBSC) harvest with G-CSF mobilization after the third or fourth induction course. Three to 6 weeks after induction, patients receive intensification chemotherapy with cyclophosphamide/thiotepa followed by PBSC. Post-transplant G-CSF is given for hematopoietic support. No concurrent hormonal therapy is permitted during induction; local irradiation of multifocal tumors is allowed provided response is still evaluable. Local therapy (excision of single metastasis, radiotherapy to metastatic site) is permitted after completion of protocol therapy. Treatment of relapsed disease is at the discretion of the investigator. Patients are followed every 3 months for 3 years or until relapse, then every 6 months. PROJECTED ACCRUAL: A total of 180 patients will be accrued over 3 years in this multicenter study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /59 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically proven glandular breast cancer - Metastatic or locoregionally relapsed disease for which curative surgery and/or radiotherapy is not feasible; Histologic/cytologic confirmation of metastasis as feasible - Progression required within the month prior to entry, whether or not it occurs on hormonal therapy - No clinically detectable cerebral or meningeal involvement - Measurable lesion required, including soft tissue site, lymphadenopathy, or visceral site The following are not considered measurable: Bony sites of involvement; Ascites; Pulmonary lymphangitic carcinomatosis; Skin lesions; Pathologic CEA or CA 15.3 levels; Laboratory changes; Pleural effusion - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior palliative chemotherapy; At least 1 year since adjuvant chemotherapy; Maximum prior cumulative anthracycline doses as follows: Epirubicin no greater than 450 mg per square meter; Doxorubicin no greater than 300 mg per square meter; Pirarubicin no greater than 300 mg per square meter; Mitoxantrone no greater than 60 mg per square meter - Endocrine therapy: Prior hormonal therapy allowed; See Disease Characteristics - Radiotherapy: At least 6 weeks since radiotherapy to more than one third of hematopoietic regions - Surgery: Not specified --Patient Characteristics-- - Age: Under 60 - Sex: Women only - Menopausal status: Not specified - Performance status: WHO 0-2 - Life expectancy: Greater than 3 months - Hematopoietic: ANC at least 2,000; Platelets at least 100,000 - Hepatic: Bilirubin no greater than 2.0 mg/dL (35 micromoles/L) - Renal: Creatinine no greater than 1.3 mg/dL (130 micromoles/L) - Cardiovascular: No congestive heart failure, even if stable; No coronary artery disease No myocardial infarction within 6 months; Ventricular ejection fraction (resting) normal by isotopic scan or echocardiogram; No evidence of cardiac disease on EKG - Other: No active infection; No second malignancy except: In situ cervical carcinoma; Basal cell skin carcinoma; No pregnant women; No psychological, familial, social, or geographical contraindication to regular follow-up
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PierreBiron, Study Chair, Federation Nationale des Centres de Lutte Contre le Cancer
Hopitaux Universitaire de Strasbourg
Strasbourg, , 67091
France
Institut J. Paoli and I. Calmettes
Marseille, , 13273
France
Centre Eugene Marquis
Rennes, , 35062
France
Hopital Sainte Blandine
Metz, , 57045
France
Centre de Lute Contre le Cancer,Georges-Francois Leclerc
Dijon, , 21079
France
Institut Jean Godinot
Reims, , 51056
France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, , 34298
France
Hopital Haut Leveque
Pessac, , 33604
France
Centre Hospitalier General
Brive, ,
France
CHR de Besancon - Hopital Jean Minjoz
Besancon, , 25030
France
Institut Claudius Regaud
Toulouse, , 31052
France
Hopital Jean Bernard
Poitiers, , 86021
France
C.H.U. de Brest
Brest, , 29200
France
Clinique Saint Vincent
Besancon, , 25044
France
Federation Nationale des Centres de Lutte Contre le Cancer
Paris, , 75654
France
Centre Jean Perrin
Clermont-Ferrand, , 63011
France
Centre Antoine Lacassagne
Nice, , 06189
France
Hopital Saint-Louis
Paris, , 75475
France
C.H. Bourg En Bresse
Bourg-en-Bresse, , 01012
France
Hopital Tenon
Paris, , 75970
France
Institut Bergonie
Bordeaux, , 33076
France
C.H.U. Saint Etienne Hospital Nord
Saint-Etienne, , 42055
France
Centre Paul Papin
Angers, , 49036
France
Centre Leon Berard
Lyon, , 69373
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, , 54511
France
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, , 37044
France
CHRU de Nancy - Hopitaux de Brabois
Vandoeuvre-les-Nancy, , 54511
France
Institut Prive de Cancerologie
Grenoble, , 38100
France
Centre Regional Francois Baclesse
Caen, , 14076
France
Hopital Louis Pasteur
Colmar, , 68024
France
Hopital Notre-Dame de Bon Secours
Metz, , 55038
France
Centre Oscar Lambret
Lille, , 59020
France
Additional Information:
Study ID Numbers: CDR0000065151; FRE-FNCLCC-PEGASE03,EU-96032
Study Start Date: December 1994
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002870
Other Recurrent Breast Cancer Studies:
1. Trastuzumab and Flavopiridol in Treating Patients With Metastatic Breast Cancer
2. Pyrazoloacridine in Treating Women With Refractory Metastatic Breast Cancer
3. Trastuzumab Plus Interleukin-2 in Treating Patients With Metastatic Breast Cancer
4. Rebeccamycin Analogue in Treating Women With Stage IIIB or Stage IV Breast Cancer
5. Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer
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High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
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