Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002784
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
1999-11-01
Brief Title:
High-Dose Combination Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Combination Chemotherapy in Treating Women With High-Risk Breast Cancer
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
Randomized Trial of High-dose Epirubicin and Cyclophosphamide x 3 Supported by Peripheral Blood Progenitor Cells Versus Anthracycline and Cyclophosphamide x 4 Followed by Cyclophosphamide Methotrexate and 5-fluorouracil x 3 as Adjuvant Treatment for High Risk Operable Stage ii and Stage Iii Breast Cancer in Premenopausal and Young Postmenopausal Less Than or Equal to 65 Yrs Patients
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
15-95
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 It is not yet known if high-dose combination chemotherapy plus peripheral stem cell transplantation is more effective than standard combination chemotherapy for breast cancer
PURPOSE Randomized phase III trial to compare high-dose combination chemotherapy plus peripheral stem cell transplantation with standard combination chemotherapy in treating women with stage II or stage III breast cancer
PURPOSE Randomized phase III trial to compare high-dose combination chemotherapy plus peripheral stem cell transplantation with standard combination chemotherapy in treating women with stage II or stage III breast cancer
Detailed Description:
OBJECTIVES I Compare the survival disease-free survival and systemic disease-free survival of women with high-risk operable stage IIIII breast cancer treated with three courses of dose-intensive epirubicincyclophosphamide EC supported by granulocyte colony-stimulating factor G-CSF and G-CSF-mobilized peripheral blood stem cells vs standard EC followed by cyclophosphamidemethotrexatefluorouracil II Compare the toxicity duration of quality-adjusted time without symptoms and toxicity and quality of life associated with these two treatments III Evaluate the cost effectiveness of these two treatments
OUTLINE This is a randomized study Patients are stratified by estrogen receptor status and menopausal status Within 6 weeks of surgery patients in the first group receive epirubicin preferred or doxorubicin plus cyclophosphamide every 3 weeks for 4 courses followed by conventional cyclophosphamide methotrexate and fluorouracil CMF every 4 weeks for 3 courses Patients in the second group undergo stem cell mobilization and harvest with granulocyte colony-stimulating factor G-CSF followed within 10 weeks of surgery by high-dose chemotherapy with epirubicin and cyclophosphamide followed by peripheral blood stem cell rescue and G-CSF All patients receive adjuvant tamoxifen and patients who underwent lumpectomy prior to entry are required to receive adjuvant radiotherapy radiotherapy is optional for patients who underwent mastectomy prior to entry Patients are followed every 3 months for 2 years then q 6 months for 3 years then yearly
PROJECTED ACCRUAL 210 patients will be accrued over 4 years to provide 195 evaluable patients
OUTLINE This is a randomized study Patients are stratified by estrogen receptor status and menopausal status Within 6 weeks of surgery patients in the first group receive epirubicin preferred or doxorubicin plus cyclophosphamide every 3 weeks for 4 courses followed by conventional cyclophosphamide methotrexate and fluorouracil CMF every 4 weeks for 3 courses Patients in the second group undergo stem cell mobilization and harvest with granulocyte colony-stimulating factor G-CSF followed within 10 weeks of surgery by high-dose chemotherapy with epirubicin and cyclophosphamide followed by peripheral blood stem cell rescue and G-CSF All patients receive adjuvant tamoxifen and patients who underwent lumpectomy prior to entry are required to receive adjuvant radiotherapy radiotherapy is optional for patients who underwent mastectomy prior to entry Patients are followed every 3 months for 2 years then q 6 months for 3 years then yearly
PROJECTED ACCRUAL 210 patients will be accrued over 4 years to provide 195 evaluable patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-96021 | None | None | None |
| IBCSG-15-95 | None | None | None |