Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00256243|
Recruitment Status : Completed
First Posted : November 21, 2005
Results First Posted : March 17, 2014
Last Update Posted : March 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Doxorubicin Drug: Cyclophosphamide Drug: Paclitaxel Drug: Carboplatin Drug: GM-CSF Drug: Trastuzumab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide (AC) With GMCSF Followed by Weekly Carboplatin/Paclitaxel With Plus or Minus Trastuzumab (TC ± H) in the Treatment of Breast Cancer|
|Study Start Date :||April 2004|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||July 2012|
Experimental: Chemotherapy with GM-CSF
Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)
This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
Patients who are her-2 overexpressors by FISH will also receive Trastuzumab with weekly carboplatin and paclitaxel as the combination has been found to be synergistic in advanced breast cancer with improved clinical outcome.
60 mg/m2 IV, bolus once every 14 days x 2-4 cycles
600 mg/m2 IV once every 14 days x 2-4 cycles
80 mg/m2 IV over 1 hour once weekly for 9-12 doses beginning two weeks after completion of last AC dose
Area under the concentration curve (AUC) 2 IV once weekly for 9-12 doses beginning two weeks after completion of last AC dose
250 μg/mL IV on day 5-14 of each subcutaneous cycle of doxorubicin and injection cyclophosphamide
AUC 2 IV weekly for 12-16 doses beginning two weeks after completion of last AC dose
- Clinical Response Rate [ Time Frame: 5 years ]Clinical response (CR): Normal breast on physical exam. No mass, no thickening, no erythema, no peau d'orange.
- Microscopic Pathological Response Rate [ Time Frame: 5 years ]pathological response rate: No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.
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): NCT00256243
|United States, California|
|Chao Family Comprehensive Cancer Center|
|Orange, California, United States, 92868|
|Principal Investigator:||Rita Mehta, MD||Chao Family Comprehensive Cancer Center|