Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00194779
Status:
COMPLETED
Last Update Posted:
2018-03-12
First Post:
2005-09-13
Brief Title:
Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
A Study of Weekly Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF Followed by Weekly Paclitaxel as Neoadjuvant Therapy for Resectable Hormone Receptor Negative or Hormone Receptor Positive HER-2Neu Positive Breast Cancer Followed by a Novel Regimen of Capecitabine Methotrexate and Vinorelbine for Patients Who Do Not Have Either a Macroscopic or Microscopic Pathologic Complete Response a Phase II Study
Status:
COMPLETED
Status Verified Date:
2018-02
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 studies how well giving combination chemotherapy and filgrastim together before surgery works in treating patients with human epidermal growth receptor 2 HER2-positive breast cancer that can be removed by surgery Drugs used in chemotherapy such as doxorubicin hydrochloride cyclophosphamide 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 combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy Giving doxorubicin hydrochloride cyclophosphamide and filgrastim together followed by paclitaxel before surgery may be an effective treatment for breast cancer
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 weekly doxorubicin doxorubicin hydrochloride and daily oral cyclophosphamide given with G-CSF filgrastim support for 12 weeks followed weekly paclitaxel for 12 weeks
SECONDARY OBJECTIVES
I To assess the clinical response rate in patients with surgically resectable breast cancer treated with weekly doxorubicin and daily oral cyclophosphamide given with G-CSF support for 12 weeks
II To assess the clinical response rate in patients with surgically resectable breast cancer treated with weekly paclitaxel for 12 weeks
III To assess the relapse rate overall and disease-free survival in patients with operable breast cancer treated with neoadjuvant chemotherapy consisting of weekly doxorubicin and daily oral cyclophosphamide given with G-CSF support for 12 weeks followed weekly paclitaxel for 12 weeks and adjuvant chemotherapy with Xeloda capecitabine Methotrexate and Navelbine vinorelbine tartrate XMN
IV To assess the toxicity associated with these regimens V To assess whether the phenotype of breast cancer changes with treatment VI To assess whether phenotypic changes in breast tumors predict outcome
OUTLINE
PART I Patients receive doxorubicin hydrochloride intravenously IV on day 1 of each week cyclophosphamide orally PO once daily QD and filgrastim subcutaneously SC QD on days 2-7 of each week Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity
PART II Patients receive paclitaxel IV over 1 hour on day 1 of each week Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity Patients then undergo definitive surgical resection by partial mastectomy lumpectomy or mastectomy after completion of neoadjuvant chemotherapy
PART III Patients unable to achieve complete pathologic response pCR or disease that has been down-staged to 1 cm with no positive nodes following surgery receive capecitabine PO twice daily BID on days 1-14 methotrexate IV on days 1 8 and 15 and vinorelbine tartrate IV over 6-10 minutes on days 1 8 and 15 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
NOTE Patients with HER2neu-positive disease also receive trastuzumab IV over 30-90 minutes once weekly or every 3 weeks for 1 year beginning in Part II
NOTE Patients with hormone receptor-positive disease also receive tamoxifen PO QD for 5 years premenopausal OR letozole PO QD or tamoxifen PO QD for 5 years postmenopausal beginning in Part III
After completion of study treatment patients are followed up 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 weekly doxorubicin doxorubicin hydrochloride and daily oral cyclophosphamide given with G-CSF filgrastim support for 12 weeks followed weekly paclitaxel for 12 weeks
SECONDARY OBJECTIVES
I To assess the clinical response rate in patients with surgically resectable breast cancer treated with weekly doxorubicin and daily oral cyclophosphamide given with G-CSF support for 12 weeks
II To assess the clinical response rate in patients with surgically resectable breast cancer treated with weekly paclitaxel for 12 weeks
III To assess the relapse rate overall and disease-free survival in patients with operable breast cancer treated with neoadjuvant chemotherapy consisting of weekly doxorubicin and daily oral cyclophosphamide given with G-CSF support for 12 weeks followed weekly paclitaxel for 12 weeks and adjuvant chemotherapy with Xeloda capecitabine Methotrexate and Navelbine vinorelbine tartrate XMN
IV To assess the toxicity associated with these regimens V To assess whether the phenotype of breast cancer changes with treatment VI To assess whether phenotypic changes in breast tumors predict outcome
OUTLINE
PART I Patients receive doxorubicin hydrochloride intravenously IV on day 1 of each week cyclophosphamide orally PO once daily QD and filgrastim subcutaneously SC QD on days 2-7 of each week Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity
PART II Patients receive paclitaxel IV over 1 hour on day 1 of each week Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity Patients then undergo definitive surgical resection by partial mastectomy lumpectomy or mastectomy after completion of neoadjuvant chemotherapy
PART III Patients unable to achieve complete pathologic response pCR or disease that has been down-staged to 1 cm with no positive nodes following surgery receive capecitabine PO twice daily BID on days 1-14 methotrexate IV on days 1 8 and 15 and vinorelbine tartrate IV over 6-10 minutes on days 1 8 and 15 Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity
NOTE Patients with HER2neu-positive disease also receive trastuzumab IV over 30-90 minutes once weekly or every 3 weeks for 1 year beginning in Part II
NOTE Patients with hormone receptor-positive disease also receive tamoxifen PO QD for 5 years premenopausal OR letozole PO QD or tamoxifen PO QD for 5 years postmenopausal beginning in Part III
After completion of study treatment patients are followed up 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-2011-00934 | REGISTRY | CTRP Clinical Trial Reporting Program | None |