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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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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

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.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
26 and older

Gender:
Female

Eligibility

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

Gender: Female
Steward Physician(s)
  • Beryl McCormick, MD
  • Clifford A. Hudis, MD
  • Barbara L. Smith, MD, PhD
  • Timothy J. Whelan, MD
  • Eileen Rakovitch, MD
Facilities
  • Norwood Hospital - Active, not recruiting
  • Saint Anne's Hospital - Active, not recruiting
Trial Interventions
Drug
  • tamoxifen citrate
Procedure
  • adjuvant therapy
Radiation
  • radiation therapy
Physician Researcher

Investigator Name:

  • Beryl McCormick, MD
  • Clifford A. Hudis, MD
  • Barbara L. Smith, MD, PhD
  • Timothy J. Whelan, MD
  • Eileen Rakovitch, MD

Other Information

Sponsor: Radiation Therapy Oncology Group
Phase: Phase 3
Trial ID: NCT00003857
Volunteers:  Not Accepting Healthy Volunteers

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