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NCT00103181 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
NA
Status at capture
COMPLETED
Registry last update
2022-04-14

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility 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 creatine phosphokinase (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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo whole breast irradiation (WBI) once daily, 5 days a week for 5-7 weeks.
    intervention Names
    1. Radiation: whole breast irradiation
    label
    Group 1: WBI
    type
    ACTIVE_COMPARATOR
  2. description
    Patients undergo partial-breast irradiation (PBI) twice daily on 5 days over a period of 5-10 days. This may be delivered by intracavitary brachytherapy, MammoSite or other single-entry intracavitary device, or 3-dimensional conformal accelerated partial breast irradiation.
    intervention Names
    1. Radiation: 3-dimensional conformal accelerated partial breast irradiation
    2. Radiation: brachytherapy
    3. Radiation: MammoSite or other single-entry intracavitary device
    label
    Group 2: PBI
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Group 2: PBI
    name
    3-dimensional conformal accelerated partial breast irradiation
    type
    RADIATION
  2. arm Group Labels
    1. Group 2: PBI
    name
    brachytherapy
    type
    RADIATION
  3. arm Group Labels
    1. Group 1: WBI
    description
    Patients undergo radiation therapy once daily (days 1-5) for up to 7 weeks
    name
    whole breast irradiation
    type
    RADIATION
  4. arm Group Labels
    1. Group 2: PBI
    name
    MammoSite or other single-entry intracavitary device
    type
    RADIATION
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
4216
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. measure
    In-breast tumor recurrence (IBTR)
    time Frame
    every 6 months for 5 years; annually thereafter for up to 10 years
secondary Outcomes
  1. measure
    Overall survival
    time Frame
    time from randomization to death due to any cause assessed up to 15 years
  2. measure
    Recurrence-free survival
    time Frame
    time from randomization to recurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years
  3. measure
    Distant disease-free survival
    time Frame
    time from randomization to event occurrence assessed every 6 months for 5 years and annually thereafter for up to 10 years
  4. measure
    Quality of life and patient-reported cosmesis by Breast Cancer Treatment Outcome Scale, MOS SF-36 Vitality, Convenience of Care scale, and symptoms
    time Frame
    measured at baseline, and 1 and 6 months and 1, 2, and 3 years after completion of study treatment
  5. measure
    Toxicity as assessed by adverse events during treatment
    time Frame
    at end of RT, and 4 weeks, 6 months, 12 months; every 6 months for years 2 through 5; and annually thereafter for up to 10 years
Full study description
brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill any tumor cells that remain after surgery. It is not yet known whether whole breast radiation therapy is more effective than partial breast radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial is studying whole breast radiation therapy to see how well it works compared to partial breast radiation therapy in treating women who have undergone surgery for ductal carcinoma in situ or stage I or stage II breast cancer.
detailed Description
OBJECTIVES: Primary * 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 following lumpectomy. Secondary * Compare overall survival, recurrence-free survival, and distant disease-free survival in patients treated with these regimens. * Compare the cosmetic result in patients treated with these regimens. * Compare fatigue and treatment-related symptoms in patients treated with these regimens. * Compare perceived convenience of care in patients treated with these regimens. * Compare acute and late toxic effects of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (ductal carcinoma in situ \[DCIS\] only vs invasive and node negative vs invasive with 1-3 positive nodes), menopausal status (premenopausal 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). Patients are randomized to 1 of 2 treatment arms. (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.) * Group 1: Patients undergo whole-breast irradiation (WBI) once daily, 5 days a week, for 5-7 weeks. * Group 2: Patients undergo partial-breast irradiation (PBI) twice daily on 5 days over a period of 5-10 days. This may be delivered by multi-catheter brachytherapy, single-entry intracavitary brachytherapy, or 3-D conformal radiotherapy. Patients in both arms may receive adjuvant chemotherapy at least 2 weeks prior to initiation of WBI OR at least 2 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 3-12 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 5 years. After completion of study treatment, patients are followed at 1 and 6 months, every 6 months for 4.5 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 4,300 patients (2,150 per treatment arm) will be accrued for this study within 4.6 years. Note: Accrual closed on April 16, 2013, following approval of the Data Monitoring Committee to reduce the sample size from 4,300 to 4,214 patients.
Source references
references
  1. citation
    Croshaw R, Kim Y, Lappinen E, Julian T, Trombetta M. Avoiding mastectomy: accelerated partial breast irradiation for breast cancer patients with pacemakers or defibrillators. Ann Surg Oncol. 2011 Nov;18(12):3500-5. doi: 10.1245/s10434-011-1784-2. Epub 2011 May 24.
    pmid
    21607774
    type
    BACKGROUND
  2. citation
    Hasan Y, Kim L, Wloch J, Chi Y, Liang J, Martinez A, Yan D, Vicini F. Comparison of planned versus actual dose delivered for external beam accelerated partial breast irradiation using cone-beam CT and deformable registration. Int J Radiat Oncol Biol Phys. 2011 Aug 1;80(5):1473-6. doi: 10.1016/j.ijrobp.2010.04.013. Epub 2010 Jul 23.
    pmid
    20656415
    type
    BACKGROUND
  3. citation
    Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22.
    pmid
    19395195
    type
    BACKGROUND
  4. citation
    Kainz K, White J, Herman J, Li XA. Investigation of helical tomotherapy for partial-breast irradiation of prone-positioned patients. Int J Radiat Oncol Biol Phys. 2009 May 1;74(1):275-82. doi: 10.1016/j.ijrobp.2008.11.028.
    pmid
    19362247
    type
    BACKGROUND
  5. citation
    Langen KM, Buchholz DJ, Burch DR, Burkavage R, Limaye AU, Meeks SL, Kupelian PA, Ruchala KJ, Haimerl J, Henderson D, Olivera GH. Investigation of accelerated partial breast patient alignment and treatment with helical tomotherapy unit. Int J Radiat Oncol Biol Phys. 2008 Mar 15;70(4):1272-80. doi: 10.1016/j.ijrobp.2007.11.019. Epub 2008 Jan 22.
    pmid
    18207666
    type
    BACKGROUND
  6. citation
    Wojcicka JB, Lasher DE, Malcom R, Fortier G. Clinical and dosimetric experience with MammoSite-based brachytherapy under the RTOG 0413 protocol. J Appl Clin Med Phys. 2007 Oct 24;8(4):176-184. doi: 10.1120/jacmp.v8i4.2654.
    pmid
    18449152
    type
    BACKGROUND
  7. citation
    Akbari M, Russo SA, Jacobson JS, et al.: Association of women's local treatment decisions with local recurrence risk and life expectancy. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2035, S228-9, 2006.
    type
    BACKGROUND
  8. citation
    Burch D, Langen KM, Buchholz D, et al.: Partial breast irradiation with helical tomotherapy using RTOG 0413 planning constraints. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-2047, S235-6, 2006.
    type
    BACKGROUND
  9. citation
    Hiatt JR, Evans SB, Price LL, Cardarelli GA, Dipetrillo TA, Wazer DE. Dose-modeling study to compare external beam techniques from protocol NSABP B-39/RTOG 0413 for patients with highly unfavorable cardiac anatomy. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1368-74. doi: 10.1016/j.ijrobp.2006.03.060.
    pmid
    16863924
    type
    BACKGROUND
  10. citation
    Bovi JA, Li XA, White J, et al.: Comparison of three partial breast irradiation techniques: treatment effectiveness based upon biological models. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-1061, S181, 2005.
    type
    BACKGROUND
  11. citation
    Dickler A. The MammoSite breast brachytherapy device: targeted delivery of breast brachytherapy. Future Oncol. 2005 Dec;1(6):799-804. doi: 10.2217/14796694.1.6.799.
    pmid
    16556059
    type
    BACKGROUND
  12. citation
    Sanghani M, Wazer DE. Patient selection for NSABP B-39/RTOG 0413: have we posed the right questions in the right way? Brachytherapy. 2007 Apr-Jun;6(2):119-22. doi: 10.1016/j.brachy.2007.01.002. No abstract available.
    pmid
    17434104
    type
    BACKGROUND
Source notices and limitations
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    Preserved source evidence · Not medical advice