This trial is active, not recruiting.

Condition breast cancer
Treatments anastrozole, tamoxifen citrate, adjuvant therapy, radiation therapy
Phase phase 2
Sponsor Institute of Cancer Research, United Kingdom
Start date April 2004
End date September 2017
Trial size 2000 participants
Trial identifier NCT00077168, CDR0000349580, EU-20341, ICR-DCIS-II


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: This randomized phase II trial is studying adjuvant radiation therapy to see how well it works compared to observation after surgery in treating women with estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Local tumor control (invasive and in situ local recurrence)
time frame:

Secondary Outcomes

Mastectomy rate
time frame:
Pattern of relapse in the breast
time frame:
Contralateral primary
time frame:
Breast cancer metastases
time frame:
time frame:
Quality of life
time frame:
Molecular markers that predict ipsilateral tumor recurrence
time frame:

Eligibility Criteria

Female participants from 40 years up to 70 years old.

DISEASE CHARACTERISTICS: - Diagnosis of unifocal ductal carcinoma in situ of the breast without an invasive component - Microinvasion (defined as 1 or more foci of invasion each < 1 mm) allowed - Prior complete microscopic excision (within the past 6 months) with a minimum radial margin of 1 mm by specimen x-ray required - Maximum microscopic tumor diameter < 30 mm (< 15 mm if grade 3 tumor) - Planning to receive adjuvant tamoxifen or anastrozole for 5 years - Eligible patients may receive adjuvant endocrine therapy on ICR-IBIS-II - Hormone receptor status: - Estrogen receptor positive OR - Progesterone receptor positive - More than 10% tumor staining for receptor OR a cutpoint of ≥ 2 PATIENT CHARACTERISTICS: Sex - Female Menopausal status - Premenopausal, perimenopausal, or postmenopausal Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Cardiovascular - No prior deep vein thrombosis Pulmonary - No prior pulmonary embolus Other - No unexplained postmenopausal bleeding - No contraindication to full-dose radiotherapy to the breast - No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - See Disease Characteristics - No prior tamoxifen or raloxifene use for more than 3 months in duration Radiotherapy - Not specified Surgery - See Disease Characteristics - No prior mastectomy Other - No concurrent anticoagulants

Additional Information

Official title Randomised Trial Testing Observation (No Radiotherapy) Against Radiotherapy In Women With Low-Risk Completely Excised ER Positive Ductal Carcinoma In Situ (DCIS) Of The Breast On Adjuvant Endocrine Therapy
Description OBJECTIVES: Primary - Compare ipsilateral tumor relapse and breast cancer metastases 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 and treated with adjuvant radiotherapy vs observation alone. - Compare the quality of life of patients treated with these regimens. Secondary - Determine the minimal surgical margins required to minimize the local recurrence rate in patients treated with these regimens. - Identify molecular markers that predict ipsilateral tumor recurrence in patients treated with these regimens. 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. - Arm I: Patients undergo radiotherapy 5 days a week for 3 or 5 weeks. - Arm II: Patients undergo observation alone. Quality of life is assessed at baseline, at 6 months, and then at 1, 2, and 5 years. Patients are followed every 6 months for 1 year and then annually for up to 10 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 2,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).