Home | | | Search | | | Browse | | | Resources | | | Help | | | What's New | | | About |
---|
Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole
This study is currently recruiting patients.
Sponsored by: | National Cancer Research Institute (NCRI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether radiation therapy after surgery is effective in preventing a recurrence of ductal carcinoma in situ.
PURPOSE: Randomized phase II trial to compare the effectiveness of adjuvant radiation therapy with that of observation after surgery in treating women who have estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.
Condition | Treatment or Intervention | Phase |
---|---|---|
intraductal breast carcinoma breast cancer in situ |
Drug: anastrozole Drug: tamoxifen Procedure: adjuvant therapy Procedure: antiestrogen therapy Procedure: aromatase inhibition Procedure: endocrine therapy Procedure: hormone therapy Procedure: radiation therapy |
Phase II |
MedlinePlus related topics: Breast Cancer; Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Randomized Study of Adjuvant Radiotherapy Versus Observation in Women With Completely Excised Low-Risk Estrogen Receptor- or Progesterone Receptor-Positive Ductal Carcinoma In Situ of the Breast Receiving Adjuvant Tamoxifen or Anastrozole
OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
All patients receive adjuvant tamoxifen or anastrozole for 5 years.
Patients are followed every 6 months for 1 year and then annually for up to 10 years.
PROJECTED ACCRUAL: A total of 2,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.
Eligibility
Ages Eligible for Study: 50 Years - 75 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
U.S. National Library of Medicine, Contact NLM Customer Service | ||||||||||||||
National Institutes of Health, Department of Health & Human Services | ||||||||||||||
Copyright, Privacy, Accessibility, Freedom of Information Act |