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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00003857
First received: November 1, 1999
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:
  • Local recurrence (e.g., invasive or noninvasive recurrence) [ Time Frame: 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Time to distant metastasis [ Time Frame: From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]
  • Invasive local recurrence [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Salvage mastectomy rate [ Time Frame: Analysis occurs after all patients have been potentially followed for 5 years. ] [ Designated as safety issue: No ]

Enrollment: 636
Study Start Date: December 1999
Primary Completion Date: February 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Observation +/- tamoxifen for 5 years
Observation +/- tamoxifen 20 mg per day for 5 years
Drug: tamoxifen citrate Procedure: adjuvant therapy
Experimental: Radiation therapy +/- tamoxifen for 5 years
Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
Drug: tamoxifen citrate Procedure: adjuvant therapy Radiation: radiation therapy

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.

  Eligibility

Ages Eligible for Study:   26 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003857

  Show 369 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
Cancer and Leukemia Group B
NCIC Clinical Trials Group
Investigators
Study Chair: Beryl McCormick, MD Memorial Sloan-Kettering Cancer Center
Investigator: Clifford A. Hudis, MD Memorial Sloan-Kettering Cancer Center
Study Chair: Barbara L. Smith, MD, PhD Massachusetts General Hospital
Study Chair: Timothy J. Whelan, MD Margaret and Charles Juravinski Cancer Centre
Investigator: Eileen Rakovitch, MD Odette Cancer Centre at Sunnybrook
  More Information

Additional Information:
No publications provided

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00003857     History of Changes
Other Study ID Numbers: RTOG-98-04, CDR0000067020, CAN-NCIC-MA26, CALGB-49801, RTOG-DEV-1026
Study First Received: November 1, 1999
Last Updated: October 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
breast cancer in situ
ductal breast carcinoma in situ

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on April 17, 2014