NCT00193115

Docetaxel Followed by Doxorubicin Plus Cyclophosphamide for Node Positive or High-Risk Primary Breast Cancer

Phase II Pilot Trial of Dose-Dense Docetaxel Followed by Doxorubicin Plus Cyclophosphamide (T-AC) Given as Adjuvant or Neoadjuvant Treatment for Women With Node Positive or High-Risk Primary Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (planned)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This protocol will evaluate the feasibility and toxicity of dose-dense docetaxel followed by doxorubicin and cyclophosphamide with support given as adjuvant or neoadjuvant treatment of women with node positive and high risk breast cancer

Detailed description

Upon determination of eligibility, patients will receive: Neoadjuvant Docetaxel + Doxorubicin + Cyclophosphamide + Surgery Adjuvant patients will enter the study after surgery and receive Docetaxel+ Doxorubicin + Cyclophosphamide. Patients treated with lumpectomy will undergo postoperative radiation therapy after completion of chemotherapy. Patients with positive estrogen and/or progesterone receptors will begin anti-estrogen therapy after the last course of chemotherapy.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Docetaxel
DRUG	Doxorubicin
DRUG	Cyclophosphamide

Timeline

• Start date: 2004-03-01
• Primary completion: 2005-06-01
• Completion: 2009-01-01
• First posted: 2005-09-19
• Last updated: 2010-08-04