Breast Cancer Articles:

Phase III Randomized Study of Adjuvant Whole Breast Versus Partial Breast Irradiation in Women With Ductal Carcinoma In Situ or Stage I or II Breast Cancer
 

Courtesy of:  National Cancer Institute
January 24, 2005

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Projected Accrual
Outline
Disclaimer
 

ALTERNATE TITLE

Radiation Therapy in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer

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BASIC TRIAL INFORMATION

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SPECIAL CATEGORY:  CTSU TRIAL

OBJECTIVES

Primary

1. Compare local tumor control in women with ductal carcinoma in situ or stage I or II breast cancer treated with adjuvant whole breast vs partial breast irradiation.

Secondary

1. Compare overall survival, recurrence-free survival, and distant disease-free survival in patients treated with these regimens.
2. Compare the cosmetic result in patients treated with these regimens.
3. Compare fatigue and treatment-related symptoms in patients treated with these regimens.
4. Compare perceived convenience of care in patients treated with these regimens.
5. Compare acute and late toxic effects of these regimens in these patients.

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ENTRY CRITERIA

Disease Characteristics:

• Histologically confirmed ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast
  • Stage 0, I, or II disease
    • Stage II tumors must be ≤ 3 cm
  • Gross disease must be unifocal
    • Microscopic multifocality allowed provided total pathological tumor size is ≤ 3 cm
  • No proven multicentric carcinoma in more than 1 quadrant or separated by ≥ 4 cm
  • No non-epithelial breast malignancies (e.g., sarcoma or lymphoma)
     
• Prior axillary staging required for patients with invasive breast cancer, including one of the following:
  • Sentinel node biopsy alone (if sentinel node is negative)
  • Sentinel node biopsy followed by axillary dissection or sampling with ≥ 6 axillary nodes (if sentinel node is positive)
  • Axillary dissection alone with ≥ 6 axillary nodes
     
• No more than three positive axillary nodes
  • No axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension
  • No positive non-axillary sentinel nodes (intramammary nodes are staged as axillary nodes)
  • No palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor
     
• Must have undergone lumpectomy
  • Resected margins histologically free of tumor
  • Re-excision of surgical margins allowed
  • Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume ≤ 30% based on postoperative CT scan
  • Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days
     
• No suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign
   
• No Paget’s Disease of the nipple
   
• No history of invasive breast cancer or DCIS
  • Prior lobular carcinoma in situ treated by surgery alone allowed
     
• No synchronous bilateral invasive or non-invasive breast cancer
   
• Partial breast irradiation deemed technically deliverable by radiation oncologist
   
• Must have undergone a history and physical exam within the past four months AND a bilateral mammogram within the past six months
   
• Hormone receptor status:
  • Estrogen receptor (ER) status known
  • Progesterone status known if ER analysis is negative
  • Marginal or borderline results are considered positive
     

Prior/Concurrent Therapy

Biologic therapy

• No prior biologic therapy for this malignancy

Chemotherapy

• No prior chemotherapy for this malignancy
• No concurrent chemotherapy during study radiotherapy

Endocrine therapy

• No prior hormonal therapy for this malignancy unless total duration of hormonal therapy was no more than 28 days
• Concurrent hormonal therapy allowed provided it is not administered during chemotherapy
• No concurrent raloxifene, tamoxifen, or other selective estrogen receptor modulating drugs
• No concurrent hormone replacement therapy
• No concurrent Femring^®

Radiotherapy

• No prior radiotherapy for this malignancy
• No prior breast or thoracic radiotherapy
• No concurrent brachytherapy boosts
• No concurrent intensity modulated radiotherapy
• No concurrent regional nodal irradiation

Surgery

• See Disease Characteristics
• No prior breast implants
  • Patients who have had implants removed are eligible

Other

• No other concurrent anticancer therapy
   

Patient Characteristics

Age

• 18 and over

Sex

• Female

Menopausal status

• Pre-menopausal or post-menopausal

Performance status

• Not specified

Life expectancy

• At least ten years, excluding diagnosis of breast cancer

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective non-hormonal contraception
• No other malignancy within the past five years except previously treated carcinoma in situ of the cervix or colon, melanoma in situ, or basal cell or squamous cell skin cancer
  • Deemed to be at low risk for recurrence
• No collagen vascular disease, specifically dermatomyositis with a CPK level above normal
• No active skin rash
• No systemic lupus erythematosus
• No scleroderma
• No psychiatric or addictive disorder that would preclude study therapy

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PROJECTED ACCRUAL

A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within two years and five months.

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OUTLINE

This is a randomized, multicenter study. Patients are stratified according to disease stage (ductal carcinoma in situ only vs invasive and node negative vs invasive with one to three positive nodes), menopausal status (pre-menopausal vs postmenopausal), hormone receptor status (estrogen receptor [ER]-positive and/or progesterone receptor [PR]-positive vs ER-negative and PR-negative), intention to receive chemotherapy (yes vs no), and participating center. Patients are randomly prescribed to one of two treatment arms.

• Arm I: Patients undergo whole breast irradiation (WBI) once daily, five days a week for five to seven weeks.
   
• Arm II: Patients undergo partial breast irradiation (PBI) twice daily on five days over a period of five to ten days.

Patients in both arms may receive adjuvant chemotherapy at least two weeks prior to initiation of WBI OR at least two weeks after completion of PBI at the discretion of the treating physician. Patients with ER-positive or PR-positive tumors may also receive hormonal therapy, beginning 3 to 12 weeks after completion of adjuvant chemotherapy (or before, during, or after completion of WBI or PBI for patients not receiving adjuvant chemotherapy) and continuing for at least five years.

Patients are followed at one and six months, every six months for 4.5 years, and then annually thereafter.

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DISCLAIMER

The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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