Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
65

Summary

Conditions
  • Inflammatory Breast Cancer
  • Invasive Ductal Breast Carcinoma
  • Invasive Lobular Breast Carcinoma
  • Mucinous Ductal Breast Carcinoma
  • Papillary Ductal Breast Carcinoma
  • Stage II Breast Cancer
  • Stage IIIA Breast Cancer
  • Stage IIIB Breast Cancer
  • Stage IIIC Breast Cancer
  • Tubular Ductal Breast Carcinoma
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

PRIMARY OBJECTIVES: I. Freedom from local failure and freedom from regional failure. SECONDARY OBJECTIVES: I. Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when tr...

PRIMARY OBJECTIVES: I. Freedom from local failure and freedom from regional failure. SECONDARY OBJECTIVES: I. Acute toxicity and late toxicity using previously published toxicity scales. II. To identify co-variates responsible for poor cosmetic outcome in women with reconstructed chest walls when treated with accelerated, hypofractionated radiotherapy. III. To correlate toxicity, cosmesis, and local control with molecular markers. OUTLINE: Patients undergo hypofractionated accelerated RT over 11 weekdays (for 15 elapsed days) within 21-63 days after last surgery or last course of chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 2-8 weeks, every 3-6 months for 3 years, every 6-12 months for 2 years, and then annually thereafter.

Tracking Information

NCT #
NCT01417286
Collaborators
  • National Cancer Institute (NCI)
  • Rutgers Cancer Institute of New Jersey
Investigators
Principal Investigator: Bruce Haffty, MD Rutgers Cancer Institute of New Jersey