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Spots Global Cancer Trial Database for Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients

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Trial Identification

Brief Title: Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Docetaxel as Neoadjuvant Treatment of Breast Cancer Patients

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

Study ID: NCT00129376

Conditions

Breast Cancer

Study Description

Brief Summary: 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.

Detailed Description: Patients received doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2), both in a short intravenous infusion, every three weeks for four cycles (days 1, 22, 43 and 64). Three weeks later, docetaxel (36 mg/m2) was administered as a 30-min intravenous infusion, weekly for six weeks (days 85, 92, 99, 106, 113 and 120) followed by a 2-week resting period (8-week cycle). After that, patients received a second docetaxel cycle (infusions on days 141, 148, 155, 162, 169 and 176). Adjuvant chemotherapy and radiotherapy were delivered according to the protocol of each participating center. Hormonal treatment was started after the last chemotherapy infusion in all patients with positive estrogen and/or progesterone receptor tumors and was continued for five years. Semiquantitative determination of three molecular markers was carried out by immunocytochemical methods. Tissue samples were taken prior to initiation of chemotherapy from the core of the primary tumors. Specimens were sent to a central laboratory for analysis of Topo II, survivin and p27.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain

Corporació Sanitaria Parc Taulí, Sabadell, Barcelona, Spain

Hospital de la Ribera, Alcira, Valencia, Spain

Complejo Hospitalario Universitario A Coruña, A Coruña, , Spain

Hospital General Universitario de Alicante, Alicante, , Spain

Fundación Jiménez Díaz, Madrid, , Spain

Contact Details

Name: Study Director

Affiliation: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Role: STUDY_DIRECTOR

Name: Study Director

Affiliation: Hospital Universitario Marqués de Valdecilla

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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