Neoadjuvant Treatment of Breast Cancer
- To measure the clinic response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2-4 cycles of biweekly doxorubicin, cyclophosphamide with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks).
- To measure the microscopic pathological response rate of this regimen.
- To measure toxicity and the delivered dose intensity of this regimen.
- To assess the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients.
- To determine whether the GM-CSF increases the post treatment dendritic cells (S100+) percentage in the tumor draining lymph node as compared to pretreatment S100+ cells.
- To determine whether the patients with a higher percent S100+ have a better clinical, pathological response, Disease Free Survival (DFS), and overall Survival (OS).
- To determine whether flow cytometry of dendritic cells performed post-treatment in blood sample shows an increase in dendritic cell population compared to pretreatment levels.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide With GMCSF Followed by Weekly Carboplatin/Nab-paclitaxel Plus or Minus Trastuzumab and Plus or Minus Bevacizumab in Treatment of Large or Inflammatory Breast Cancer-a Phase II Study|
- Overall Clinical Response to the Dose Dense Regimen [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: AC with GM-CSF and Carboplatin/Nab-Paclitaxel
Doxorubicin and cyclophosphamide (AC) administered intravenously every 14 days up to a total of 4 cycles, with GM-CSF on days 4-13, depending on tumor response.
Two weeks after the completion of AC, weekly doses of carboplatin/nab-paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. Subjects who receive 4 cycles of AC will receive 9 doses of nab-paclitaxel and subjects who receive 2 cycles of AC will receive 12 weeks of nab-paclitaxel. In addition, subjects will receive trastuzumab weekly (12-16) doses if they are Her-2 positive and bevacizumab (6-8) doses every 2 weeks if they are Her-2 negative. Each clinic visit will last approximately ½ hour.
60 mg/m2 IV, bolus once a day every 14 days x 2-4 cycles
Other Names:Drug: Cyclophosphamide
600 mg/m2 IV once a day every 14 days x 2-4 cycles
Other Names:Drug: Carboplatin
AUC 2 IV weekly for 9-12 doses beginning two weeks after completion of last AC dose
Other Names:Drug: Nab-paclitaxel
100 mg/m2 IV over 30 min weekly for 9-12 doses beginning two weeks after completion of last AC dose
Other Names:Drug: GM-CSF
250 μg/mL IV or on day 4-13 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide
Other Names:Drug: Trastuzumab
4mg/kg, and then2 mg/kg q wk IV weekly for 12-16 doses beginning two weeks after completion of last AC doseDrug: Bevacizumab
10mg/kg q 2 wks
Other Name: Avastin
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00254592
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Rita Mehta, M.D.||Chao Family Comprehensive Cancer Center|