Neoadjuvant Treatment of Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00254592|
Recruitment Status : Active, not recruiting
First Posted : November 16, 2005
Results First Posted : November 11, 2013
Last Update Posted : February 9, 2018
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Doxorubicin Drug: Cyclophosphamide Drug: Carboplatin Drug: Nab-paclitaxel Drug: GM-CSF Drug: Trastuzumab Drug: Bevacizumab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||October 2005|
|Actual Primary Completion Date :||September 4, 2013|
|Estimated Study Completion Date :||December 28, 2018|
U.S. FDA Resources
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
- Overall Clinical Response to the Dose Dense Regimen [ Time Frame: 3 years ]Measure clinical 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 GMCSF (day 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 learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|