Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients
|ClinicalTrials.gov Identifier: NCT00129376|
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : March 19, 2018
Treatment consists of 4 AC cycles followed by 2 weekly docetaxel cycles (12 infusions).
The pathological complete response rate obtained in previous studies is around 12%. The expected pathological complete response rate in this study is 25%. With an alpha error of 0.05 and a beta error of 0.2, and following Simon´s 2 phase test, 19 patients are needed initially. With 2 pathological complete responses, patient recruitment will continue until approximately 61 patients are recruited. Twelve pathological complete responses are needed to confirm the study hypothesis.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: docetaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||63 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter Phase II Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel (T) as Neoadjuvant Treatment for Operable Stage II and IIIA Breast Cancer Patients|
|Actual Study Start Date :||February 2003|
|Primary Completion Date :||July 2005|
|Study Completion Date :||February 2010|
Experimental: Doxorubicin+cyclophosphamide - Docetaxel
Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles. Later, docetaxel (36 mg/m2) was administered an intravenous infusion, weekly for six weeks followed by a 2-week resting period (8-week cycle).
- Pathological complete response [ Time Frame: up to 24 weeks ]Defined by the Miller & Payne criteria
- Clinical response rate [ Time Frame: up to 24 weeks ]The clinical response is measured according to the RECIST criteria.
- Toxicity [ Time Frame: up to 12 weeks ]Is measured according to the scale of the NCI version 2.0
- Disease-free survival [ Time Frame: From date of randomization until the date of first documented progression (if it is applicable), assessed up to 72 months ]Interval from the date of registration in the study to the date of local, regional or metastatic recurrence or the date on which the second primary cancer manifests or death occurs for any reason, depending on the circumstance that occurs first .
- Overall survival [ Time Frame: From date of randomization until the date of death from any cause, assessed up to 72 months ]Interval from the date of registration in the study to the date in which the death occurs for any reason.
- Molecular markers and correlation with response [ Time Frame: through study completion, an average of 2 years ]The predictive response markers will be determined by the usual techniques
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129376
|Hospital Universitario Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Corporació Sanitaria Parc Taulí|
|Sabadell, Barcelona, Spain, 08208|
|Hospital de la Ribera|
|Alcira, Valencia, Spain, 46600|
|Complejo Hospitalario Universitario A Coruña|
|A Coruña, Spain, 15006|
|Hospital General Universitario de Alicante|
|Alicante, Spain, 03010|
|Fundación Jiménez Díaz|
|Madrid, Spain, 28040|
|Study Director:||Study Director||Fundación Jiménez Díaz|
|Study Director:||Study Director||Hospital Universitario Marqués de Valdecilla|