Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: tamoxifen citrate; Procedure: adjuvant therapy; Radiation: radiation therapy

• Registration Number: NCT00003857
• Lead Sponsor: Radiation Therapy Oncology Group

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.

Detailed Description

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.

Study Timeline

• Study First Submitted: 1999-11-01
• Study Start: 1999-12
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-02
• Status Verified: 2022-05
• Study Completion: 2022-05-20
• Last Update Submitted: 2022-05-23
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 636

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiation therapy +/- tamoxifen for 5 years	tamoxifen citrate	Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
Observation +/- tamoxifen for 5 years	tamoxifen citrate	Observation +/- tamoxifen 20 mg per day for 5 years
Observation +/- tamoxifen for 5 years	adjuvant therapy	Observation +/- tamoxifen 20 mg per day for 5 years
Radiation therapy +/- tamoxifen for 5 years	adjuvant therapy	Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
Radiation therapy +/- tamoxifen for 5 years	radiation therapy	Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years

Primary Outcome Measures

Name	Time	Method
Local recurrence (e.g., invasive or noninvasive recurrence)	From randomization to date of local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.

Secondary Outcome Measures

Name	Time	Method
Overall survival	From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
Time to distant metastasis	From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
Invasive local recurrence	From randomization to date of invasive local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years.
Salvage mastectomy rate	Analysis occurs after all patients have been potentially followed for 5 years.

Trial Locations

Locations (369)

Mobile Infirmary Medical Center; 🇺🇸 Mobile, Alabama, United States

Fairbanks Cancer Treatment Center at Fairbanks Memorial Hospital; 🇺🇸 Fairbanks, Alaska, United States

Arizona Oncology Services Foundation; 🇺🇸 Phoenix, Arizona, United States

Saint Joseph's Mercy Cancer Center; 🇺🇸 Hot Springs, Arkansas, United States

Providence Saint Joseph Medical Center - Burbank; 🇺🇸 Burbank, California, United States

Enloe Cancer Center at Enloe Medical Center; 🇺🇸 Chico, California, United States

Mount Diablo Regional Cancer Center; 🇺🇸 Concord, California, United States

North Bay Cancer Center; 🇺🇸 Fairfield, California, United States

Washington Township Hospital; 🇺🇸 Fremont, California, United States

Saint Agnes Medical Center; 🇺🇸 Fresno, California, United States

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