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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00103181
• Date of registration: 07/02/2005
• Primary sponsor: National Surgical Adjuvant Breast and Bowel Project (NSABP)
• Public title: Radiation Therapy in Treating Women Who Have Undergone Surgery For Ductal Carcinoma In Situ or Stage I or Stage II Breast Cancer
• Scientific title: A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women With Stage 0, I, or II Breast Cancer
• Date of first enrolment: March 2005
• Target sample size: 4300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00103181
• Study type: Interventional
• Study design: Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada, Ireland, Israel, United States

Contacts

• Name: Douglas W. Arthur, MD
• Affiliation: Massey Cancer Center

• Name: Julia R. White, MD
• Affiliation: Medical College of Wisconsin

• Name: Rachel A. Rabinovitch, MD
• Affiliation: University of Colorado, Denver

• Name: Lori J. Pierce, MD
• Affiliation: University of Michigan Cancer Center

• Name: Robert R. Kuske, MD
• Affiliation: University of Wisconsin, Madison

• Name: Frank Vicini, MD, FACR
• Affiliation: William Beaumont Hospital - Royal Oak Campus

Key inclusion & exclusion 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) NOTE:
*Patients who are 50 years of age and over with DCIS regardless of hormone
receptor status AND patients with invasive breast cancer meeting all of the
following criteria: = 50 years of age, node-negative, and hormone-receptor
positive status will not be enrolled in study after 12/30/2006

- Prior axillary staging required for patients with invasive breast cancer, including 1
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 3 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 pre-randomization 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 at
a credentialed facility

- Must have undergone a history and physical exam within the past 4 months AND a
bilateral mammogram within the past 6 months

- Hormone receptor status:

- Estrogen receptor (ER) status known

- Progesterone status known if ER analysis is negative

- Marginal or borderline results are considered positive

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Female

Menopausal status

- Premenopausal or postmenopausal

Performance status

- Not specified

Life expectancy

- At least 10 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 5 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 (e.g., systemic lupus erythematosus or scleroderma),
specifically dermatomyositis with a CPK level above normal, or active skin rash

- No psychiatric or addictive disorder that would preclude study therapy

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 before randomization

- 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Radiation: 3-dimensional conformal accelerated partial breast irradiation

Radiation: brachytherapy

Radiation: whole breast irradiation

Primary Outcome(s)

In-breast tumor recurr. (IBTR) at event occurrence, every 6 mo. for 5 yrs; after 175 IBTR events are obs'd at approx. 10 yrs after study init.; after a spec. no. of events are observed at approx. 4.1 yrs after study init.; and annually thereafter [Time Frame: No]

Secondary Outcome(s)

Distant disease-free survival at event occurrence or every 6 months for 5 years and at recurrence or annually for 5 years [Time Frame: No]

Physician-reported cosmesis as assessed by physician cosmesis evaluation and digital photographs of treated and untreated breasts at baseline and 1 and 3 years after completion of study treatment [Time Frame: No]

Quality of life and patient-reported cosmesis by Breast Cancer Treatment Outcome Scale, MOS SF-36 Vitality, Convenience of Care scale, and symptoms at baseline, after completion of study tx, and 1 & 6 mo. and 1-3 years after completion of study tx [Time Frame: No]

Recurrence-free survival at event occurrence OR every 6 months for 5 years and annually thereafter [Time Frame: No]

Survival at event occurrence OR every 6 months for 5 years, and annually thereafter [Time Frame: No]

Toxicity as assessed by adverse events during treatment, and at 4 weeks, 6 months, 12 months, and annually after completion of study treatment [Time Frame: Yes]

Secondary ID(s)

CDR0000409590

NSABP-B-39

RTOG-0413

SWOG-NSABP-B-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Southwest Oncology Group