Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00403182
Status:
WITHDRAWN
Last Update Posted:
2012-06-01
First Post:
2006-11-21
Brief Title:
Chemotherapy and Hormone Therapy as First-Line Therapy in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
The CORE Study Chemotherapy OR Endocrine Treatment First A Randomized Study by the Scandinavian Breast Group CORE
Status:
WITHDRAWN
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study halted prematurely prior to enrollment of first participant
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Estrogen can cause the growth of breast cancer cells Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes It is not yet known whether giving chemotherapy before hormone therapy is more effective than giving hormone therapy before chemotherapy in treating breast cancer
PURPOSE This randomized phase III trial is studying chemotherapy to see how well it works when given before or after hormone therapy as first-line therapy in treating postmenopausal women with metastatic or locally advanced breast cancer
PURPOSE This randomized phase III trial is studying chemotherapy to see how well it works when given before or after hormone therapy as first-line therapy in treating postmenopausal women with metastatic or locally advanced breast cancer
Detailed Description:
OBJECTIVES
Determine the optimal sequence of chemotherapy and endocrine therapy as first-line therapy in postmenopausal women with metastatic or locally advanced breast cancer that is potentially sensitive to both modalities
OUTLINE This is an open-label randomized crossover multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I chemotherapy first Beginning within 4 weeks after randomization patients receive chemotherapy comprising either an anthracycline- or a taxane-based regimen or a combination of both drugs according to local institutional guidelines Treatment continues for 6 months or longer in the absence of disease progression or unacceptable toxicity After discontinuation of chemotherapy patients receive endocrine therapy comprising oral letrozole once daily in the absence of disease progression or unacceptable toxicity Patients with immediately life-threatening disease eg lymphangitis carcinomatosa or liver involvement exceeding 13 of the liver are recommended for second-line chemotherapy
NOTE Patients may receive chemotherapy on a separate clinical chemotherapy trial but must first undergo randomization in this study
Arm II endocrine therapy firstBeginning immediately after randomization patients receive oral letrozole once daily in the absence of disease progression or unacceptable toxicity Patients who demonstrate progressive disease then receive chemotherapy as in arm I
Quality of life and pain are assessed at baseline and then periodically for 5 years
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 1500 patients will be accrued for this study
Determine the optimal sequence of chemotherapy and endocrine therapy as first-line therapy in postmenopausal women with metastatic or locally advanced breast cancer that is potentially sensitive to both modalities
OUTLINE This is an open-label randomized crossover multicenter study Patients are stratified according to participating center Patients are randomized to 1 of 2 treatment arms
Arm I chemotherapy first Beginning within 4 weeks after randomization patients receive chemotherapy comprising either an anthracycline- or a taxane-based regimen or a combination of both drugs according to local institutional guidelines Treatment continues for 6 months or longer in the absence of disease progression or unacceptable toxicity After discontinuation of chemotherapy patients receive endocrine therapy comprising oral letrozole once daily in the absence of disease progression or unacceptable toxicity Patients with immediately life-threatening disease eg lymphangitis carcinomatosa or liver involvement exceeding 13 of the liver are recommended for second-line chemotherapy
NOTE Patients may receive chemotherapy on a separate clinical chemotherapy trial but must first undergo randomization in this study
Arm II endocrine therapy firstBeginning immediately after randomization patients receive oral letrozole once daily in the absence of disease progression or unacceptable toxicity Patients who demonstrate progressive disease then receive chemotherapy as in arm I
Quality of life and pain are assessed at baseline and then periodically for 5 years
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 1500 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KRDI-TUM-COR-259-PAE-0100-I | None | None | None |
| KRDI-TUM-CORE-GYN-040-380-2126 | None | None | None |
| EU-20660 | None | None | None |
| EUDRACT-2005-000986-20 | None | None | None |