Dose Dense TC + Pegfilgrastim Support for Breast Cancer (ddTC)
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|ClinicalTrials.gov Identifier: NCT01671319|
Recruitment Status : Completed
First Posted : August 23, 2012
Results First Posted : October 12, 2017
Last Update Posted : October 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Female Breast Cancer||Drug: docetaxel + cyclophosphamide + pegfilgrastim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Dose-Dense TC (Docetaxel + Cyclophosphamide) With Pegfilgrastim Support for Adjuvant Therapy of pN0, pN1 or Nx Breast Cancer|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Experimental: dose dense TC + pegfilgrastim
Docetaxel + Cyclophosphamide chemotherapy given every 2 weeks x 4 cycles plus pegfilgrastim given 24-48 hours post day 1 of each cycle
Drug: docetaxel + cyclophosphamide + pegfilgrastim
docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle
Other Name: Taxotere, Cytoxan, Neulasta
- Feasibility for Dose-dense TC Therapy: Number of Participants Receiving at Least 90% of Total Dose of Therapy [ Time Frame: 4 cycles each 2 weeks in length for a total of 8 weeks, up to 10 weeks ]Evaluate feasibility of delivering 4 cycles (1 cycle = 2 weeks) of docetaxel and cyclophosphamide (TC) on a dose-dense (q2week) schedule with pegfilgrastim support. This regimen will be referred to as dose-dense (dd)TC. Feasibility defined by at least 60% of patients receiving 90% of the total dose of therapy within 10 weeks.
- Incidence of Febrile Neutropenia [ Time Frame: Up to 10 weeks ]Neutropenic fever was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.
- Incidence of Neuropathy [ Time Frame: Up to 10 weeks ]Neuropathy was anticipated to be a clinically significant toxicity that would limit the maximal density of TC therapy.
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): NCT01671319
|United States, Wisconsin|
|University of Wisconsin Carbone Cancer Center|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Amye J Tevaarwerk, MD||University of Wisconsin, Madison|