Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194792
Status:
TERMINATED
Last Update Posted:
2017-07-11
First Post:
2005-09-14
Brief Title:
Hormone Therapy and Combination Chemotherapy Before and After Surgery in Treating Patients With Stage I-IIIA Breast Cancer
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Neoadjuvant Complete Hormonal Blockade Followed by Neoadjuvant Chemotherapy for Resectable Hormone Receptor Positive HER-2Neu Negative Breast Cancer A Phase II Study
Status:
TERMINATED
Status Verified Date:
2017-06
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:
None
Brief Summary:
This phase II trial is studying how well giving hormone therapy together with combination chemotherapy before and after surgery works in treating patients with stage I-IIIA breast cancer Estrogen can cause the growth of breast cancer cells Hormone therapy using exemestane and triptorelin pamoate may fight breast cancer by lowering the amount of estrogen the body makes Drugs used in chemotherapy such as capecitabine methotrexate vinorelbine ditartrate and paclitaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving hormone therapy together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving these treatments after surgery may kill any tumor cells that remain after surgery
Detailed Description:
PRIMARY OBJECTIVES
I To assess the pathologic response rate in patients with operable breast cancer treated with a two part neoadjuvant regimen consisting of complete hormonal blockade CHB for 2 weeks followed by four three-week cycles of Xeloda Methotrexate and Navelbine with continuation of complete hormonal blockade
SECONDARY OBJECTIVES
I To assess the clinical response rate in patients with surgically resectable breast cancer treated with complete hormonal blockade and four three-week cycles of Xeloda Methotrexate and Navelbine
II To assess the toxicity associated with these regimens III To assess the relapse rate overall and disease-free survival in patients with operable breast cancer when treated with neoadjuvant CHB and XMN CHB followed by adjuvant treatment using XMN or Taxol
IV To assess whether the phenotype of breast cancer changes with treatment V To assess whether phenotypic changes in breast tumors predict outcome
OUTLINE
NEOADJUVANT CHB Patients receive exemestane orally PO daily for 14 weeks Premenopausal patients also receive triptorelin pamoate intramuscularly IM once monthly for 4 months beginning 2 weeks before the initiation of exemestane
NEOADJUVANT CHEMOTHERAPY Patients receive capecitabine PO twice daily BID on days 1-14 and methotrexate intravenously IV and vinorelbine ditartrate IV over 6-10 minutes on days 1 8 and 15 Treatment repeats every 21 days for 4 courses
SURGERY Patients then undergo definitive surgical resection with or without radiation therapy
ADJUVANT CHEMOTHERAPY Patients with microscopic complete response pCR or disease that has been down-staged to 1 cm with no positive nodes receive capecitabine PO BID on days 1-14 and methotrexate IV and vinorelbine ditartrate IV over 6-10 minutes on days 1 8 and 15 Treatment repeats every 21 days for 4 courses Patients with down-staged T and 0 or 1 positive node receive paclitaxel IV over 1 hour once weekly for 12 weeks
ADJUVANT HORMONAL THERAPY Patients receive hormonal therapy for 5 years
Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
I To assess the pathologic response rate in patients with operable breast cancer treated with a two part neoadjuvant regimen consisting of complete hormonal blockade CHB for 2 weeks followed by four three-week cycles of Xeloda Methotrexate and Navelbine with continuation of complete hormonal blockade
SECONDARY OBJECTIVES
I To assess the clinical response rate in patients with surgically resectable breast cancer treated with complete hormonal blockade and four three-week cycles of Xeloda Methotrexate and Navelbine
II To assess the toxicity associated with these regimens III To assess the relapse rate overall and disease-free survival in patients with operable breast cancer when treated with neoadjuvant CHB and XMN CHB followed by adjuvant treatment using XMN or Taxol
IV To assess whether the phenotype of breast cancer changes with treatment V To assess whether phenotypic changes in breast tumors predict outcome
OUTLINE
NEOADJUVANT CHB Patients receive exemestane orally PO daily for 14 weeks Premenopausal patients also receive triptorelin pamoate intramuscularly IM once monthly for 4 months beginning 2 weeks before the initiation of exemestane
NEOADJUVANT CHEMOTHERAPY Patients receive capecitabine PO twice daily BID on days 1-14 and methotrexate intravenously IV and vinorelbine ditartrate IV over 6-10 minutes on days 1 8 and 15 Treatment repeats every 21 days for 4 courses
SURGERY Patients then undergo definitive surgical resection with or without radiation therapy
ADJUVANT CHEMOTHERAPY Patients with microscopic complete response pCR or disease that has been down-staged to 1 cm with no positive nodes receive capecitabine PO BID on days 1-14 and methotrexate IV and vinorelbine ditartrate IV over 6-10 minutes on days 1 8 and 15 Treatment repeats every 21 days for 4 courses Patients with down-staged T and 0 or 1 positive node receive paclitaxel IV over 1 hour once weekly for 12 weeks
ADJUVANT HORMONAL THERAPY Patients receive hormonal therapy for 5 years
Treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months for 3 years every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| NCI-2010-00549 | REGISTRY | CTRP Clinical Trial Reporting Program | None |