Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00066807
Status:
TERMINATED
Last Update Posted:
2016-10-28
First Post:
2003-08-06
Brief Title:
Premenopausal Endocrine Responsive Chemotherapy Trial
Sponsor:
ETOP IBCSG Partners Foundation
Organization:
ETOP IBCSG Partners Foundation
Study Overview
Official Title:
A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women With Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy
Status:
TERMINATED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor accrual patients were followed until completion of 5 yrs treatment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PERCHE
Brief Summary:
The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years The use of chemotherapy was determined by randomization The method of ovarian function suppression GnRH analogue for five years surgical oophorectomy or ovarian irradiation and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial recommended option The trial was terminated early due to poor accrual
Detailed Description:
OBJECTIVES
Compare ovarian function suppression and tamoxifen or exemestane with vs without adjuvant chemotherapy in premenopausal women with endocrine-responsive resected breast cancer
Compare the disease-free and overall survival of patients treated with these regimens
Compare sites of first treatment failure in patients treated with these regimens
Compare the incidence of second nonbreast malignancies in patients treated with these regimens
Compare the quality of life including late side effects of early menopause of patients treated with these regimens
PLANNED OUTLINE
This is a randomized multicenter study Patients are stratified according to participating center number of positive axillary andor internal mammary lymph nodes 0 vs 1 or more method of ovarian function suppression triptorelin vs oophorectomy vs ovarian irradiation chemotherapy if randomized to arm II not containing vs containing an anthracycline or taxane and endocrine agent tamoxifen vs exemestane vs selected by subsequent randomization in the TEXT trial Treatment duration is five years
Quality of life is assessed at baseline every 6 months for 2 years and then annually for 4 years Patients are followed every 3 months for 1 year every 6 months for 5 years and then annually thereafter
NOTE Trial was terminated early due to poor accrual
Compare ovarian function suppression and tamoxifen or exemestane with vs without adjuvant chemotherapy in premenopausal women with endocrine-responsive resected breast cancer
Compare the disease-free and overall survival of patients treated with these regimens
Compare sites of first treatment failure in patients treated with these regimens
Compare the incidence of second nonbreast malignancies in patients treated with these regimens
Compare the quality of life including late side effects of early menopause of patients treated with these regimens
PLANNED OUTLINE
This is a randomized multicenter study Patients are stratified according to participating center number of positive axillary andor internal mammary lymph nodes 0 vs 1 or more method of ovarian function suppression triptorelin vs oophorectomy vs ovarian irradiation chemotherapy if randomized to arm II not containing vs containing an anthracycline or taxane and endocrine agent tamoxifen vs exemestane vs selected by subsequent randomization in the TEXT trial Treatment duration is five years
Quality of life is assessed at baseline every 6 months for 2 years and then annually for 4 years Patients are followed every 3 months for 1 year every 6 months for 5 years and then annually thereafter
NOTE Trial was terminated early due to poor accrual
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 |
|---|---|---|---|
| CDR0000318832 | REGISTRY | CTgov | None |
| NABCI-IBCSG-26-02 | None | None | None |
| EU-20401 | None | None | None |
| 2005-002626-59 | EUDRACT_NUMBER | None | None |