Ignite Creation Date:
2024-05-04 @ 6:49 PM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003953
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
1999-11-01
Brief Title:
Chemotherapy Followed by Surgery in Treating Women With Stage II or Stage III Breast Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Phase II Study of Preoperative Dose-Dense Chemotherapy With Sequential Doxorubicin and Docetaxel for Initial Treatment of Operable and Inoperable Stage II-IIIB Breast Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of doxorubicin and docetaxel followed by surgery in treating women who have stage II or stage III breast cancer
PURPOSE Phase II trial to study the effectiveness of doxorubicin and docetaxel followed by surgery in treating women who have stage II or stage III breast cancer
Detailed Description:
OBJECTIVES I Determine the clinical and pathological response of women with stage II-IIIB primary breast cancer to preoperative high dose chemotherapy with sequential doxorubicin and docetaxel II Determine the safety and toxicity of this regimen in these patients III Determine the rate of breast conservation surgery in these patients on this regimen IV Determine the clinical response of these patients to docetaxel after 3 courses of doxorubicin V Correlate any circulating tumor cells shed at time of surgery with clinical response and pathological findings in these patients VI Determine whether tumor response correlates with HER2neu expression of the primary tumor
OUTLINE Patients receive doxorubicin IV on days 1 15 and 29 followed by docetaxel IV over 1 hour on days 43 57 and 71 Filgrastim G-CSF is administered subcutaneously on days 3-10 of each 2 week course Fourteen to 21 days following preoperative chemotherapy patients undergo a radical modified radical or breast sparing surgery plus axillary lymph node dissection Patients with disease progression or inoperable stage IIIB disease are removed from study Following surgery patients are stratified into one of three postoperative regimens Stratum I Patients with 0 lymph node metastases receive no further chemotherapy or receive cyclophosphamide methotrexate and fluorouracil CMF for 4 courses Stratum II Patients with 1-3 lymph node metastases receive CMF for 4 courses Stratum III Patients with at least 4 lymph node metastases or stage IIIB may receive high dose chemotherapy with stem cell support Two to 6 weeks after surgery patients undergoing breast sparing procedure receive adjuvant radiotherapy Patients undergoing mastectomy receive chest wall and supraclavicular radiotherapy if initial clinical stage is T3 T4 or N2 All other patients with N1 with greater than 4 lymph nodes and N3 should receive radiotherapy Radiotherapy is administered 5 days a week for 55 weeks Patients with positive estrogen or progesterone receptors receive oral tamoxifen daily for 5 years Patients are followed every 3 months for 3 years then every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL Approximately 27-35 patients will be accrued for this study
OUTLINE Patients receive doxorubicin IV on days 1 15 and 29 followed by docetaxel IV over 1 hour on days 43 57 and 71 Filgrastim G-CSF is administered subcutaneously on days 3-10 of each 2 week course Fourteen to 21 days following preoperative chemotherapy patients undergo a radical modified radical or breast sparing surgery plus axillary lymph node dissection Patients with disease progression or inoperable stage IIIB disease are removed from study Following surgery patients are stratified into one of three postoperative regimens Stratum I Patients with 0 lymph node metastases receive no further chemotherapy or receive cyclophosphamide methotrexate and fluorouracil CMF for 4 courses Stratum II Patients with 1-3 lymph node metastases receive CMF for 4 courses Stratum III Patients with at least 4 lymph node metastases or stage IIIB may receive high dose chemotherapy with stem cell support Two to 6 weeks after surgery patients undergoing breast sparing procedure receive adjuvant radiotherapy Patients undergoing mastectomy receive chest wall and supraclavicular radiotherapy if initial clinical stage is T3 T4 or N2 All other patients with N1 with greater than 4 lymph nodes and N3 should receive radiotherapy Radiotherapy is administered 5 days a week for 55 weeks Patients with positive estrogen or progesterone receptors receive oral tamoxifen daily for 5 years Patients are followed every 3 months for 3 years then every 6 months for 5 years and then annually thereafter
PROJECTED ACCRUAL Approximately 27-35 patients will be accrued for this study
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-G99-1537 | Other Identifier | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| CWRU-2198 | OTHER | None | None |
| P30CA043703 | NIH | None | None |