Completed

Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast

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What is being tested

tamoxifen citrate

+ adjuvant therapy

+ tamoxifen citrate

DrugProcedureRadiation
Who is being recruted

Adenocarcinoma+11

+ Breast Diseases

+ Carcinoma

From 26 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: December 1999
See protocol details

Summary

Principal SponsorRadiation Therapy Oncology Group
Last updated: May 25, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1999

Actual date on which the first participant was enrolled.

OBJECTIVES: Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast. Compare distant disease-free survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years. Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.

NCT00003857
Principal SponsorRadiation Therapy Oncology Group
Last updated: May 25, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

636 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 26 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaBreast DiseasesCarcinomaCarcinoma in SituNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Ductal, Lobular, and MedullaryBreast Carcinoma In SituBreast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Criteria

DISEASE CHARACTERISTICS: Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis Unicentric Lesions ≤ 2.5 cm Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in < one third of the involved ducts Inked margins ≥ 3 mm Clinically node negative Non-palpable No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery No bloody nipple discharge No more than 12 weeks since prior final surgery (arm II only) Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 26 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing No active connective tissue disorders (e.g., lupus or scleroderma) No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills) Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
Observation +/- tamoxifen 20 mg per day for 5 years

Group II

Experimental
Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 369 locations

Mobile Infirmary Medical Center

Mobile, United StatesOpen Mobile Infirmary Medical Center in Google Maps

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital

Fairbanks, United States

Arizona Oncology Services Foundation

Phoenix, United States

Saint Joseph's Mercy Cancer Center

Hot Springs, United States
Completed369 Study Centers