Ductal Breast Carcinoma In SituPhase 2NCT01266642
Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer
A Phase 2 study testing External Beam Radiation Therapy, Hypofractionated Radiation Therapy and Laboratory Biomarker Analysis in people with Ductal Breast Carcinoma In Situ and Invasive Breast Carcinoma, run by M.D. Anderson Cancer Center at 7 sites in United States.
Trial summary
This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor cells. Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v6
- What is being tested?
- External Beam Radiation Therapy, Hypofractionated Radiation Therapy and Laboratory Biomarker Analysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 301 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Feb 2011to 30 Nov 2040
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed ductal carcinoma in situ of the breast or early invasive breast cancer defined as pathologic stage Tis, T1, or T2, N0, N1mic, or N1a (pathologic staging of the axilla is required for all patients with invasive disease but is not required for patients with ductal carcinoma in situ [DCIS] only); (upfront pathologic stage cannot be assigned to patients treated with neoadjuvant chemotherapy; for such patients, the criteria for pathologic stage shall be applied to the initial clinical stage)
- Treatment with breast conserving surgery
- Final surgical margins must be negative, defined as no evidence for ductal carcinoma in situ or invasive breast cancer touching the inked surgical margin; if the invasive or in situ breast cancer approaches within less than 1 mm of the final surgical margin, then a re-excision is strongly encouraged; lobular carcinoma in situ at the final surgical margin will be disregarded
- Age 40 years or older. This age cutoff is justified because breast cancers in women under the age of 40 are known to have a significantly higher risk of IBTR presumably due to underlying biologic differences.
- Female sex.
- Attending radiation oncologist declares intention to treat the whole breast only and that a third radiation field to treat regional lymph nodes is not planned (radiation of the undissected level I/II axilla with high tangents is allowed)
- If the patient has a history of a prior non-breast cancer, all treatment for this cancer must have been completed prior to study registration and the patient must have no evidence of disease for this prior non-breast cancer
- Patients must be enrolled on the trial within 12 weeks of the later of two dates: the final breast conserving surgical procedure or administration of the last cycle of concurrent cytotoxic chemotherapy
Who cannot join
- Pathologic or clinical evidence for a stage T3 or T4 breast cancer
- Pathologic evidence for involvement of 4 or more axillary lymph nodes, or imaging evidence of involvement of infraclavicular, supraclavicular, or internal mammary lymph nodes
- Clinical or pathologic evidence for distant metastases
- Any prior diagnosis of invasive or ductal carcinoma in situ breast cancer in either breast
- Current diagnosis of bilateral breast cancer
- History of therapeutic irradiation to the breast, lower neck, mediastinum or other area in which there could potentially be overlap with the affected breast
- Patients not fluent in English or Spanish (The BCTOS will be available in these two languages)
- Patient is pregnant
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
MD Anderson in The Woodlands
Conroe, Texas, 77384
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234
M D Anderson Cancer Center
Houston, Texas, 77030
MD Anderson West Houston
Houston, Texas, 77079
MD Anderson League City
League City, Texas, 77573
UF Cancer Center at Orlando Health
Orlando, Florida, 32806
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
About this study
Official title: Randomized Trial of Hypofractionated Whole Breast Irradiation Versus Conventionally Fractionated Whole Breast Irradiation for Ductal Carcinoma In Situ and Early Invasive Breast Cancer
This randomized phase II trial studies how well hypofractionated radiation therapy (RT) works compared to standard RT in treating patients with ductal breast carcinoma in situ (DCIS) or early invasive breast cancer. Radiation therapy (RT) uses high energy x-rays to kill tumor cells. Giving higher doses of RT over a shorter period of time may kill more tumor cells and have fewer side effects. It is not yet known if hypofractionated RT is more effective than standard RT in treating breast cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To compare patient-reported cosmetic outcome at 3 years using the Breast Cancer Treatment Outcomes Scale (BCTOS) for patients assigned to hypofractionated whole breast irradiation (HF-WBI) versus conventionally fractionated whole breast irradiation (CF-WBI).
SECONDARY OBJECTIVES:
- To determine patient-reported cosmetic outcome using the BCTOS at 6 months, 1, 2, 4, and 5 years.
II. To determine physician-rated cosmetic outcome at 6 months, 1, 2, 3, 4, and 5 years using the Radiation Therapy and Oncology Group (RTOG) scale for physician assessment.
III. To determine the level of agreement between patient-rated cosmetic outcome and physician-rated cosmetic outcome at the various time points assessed.
IV. To determine the 5-year and risk of pathologically-confirmed invasive and/or in situ ipsilateral breast tumor recurrence (IBTR) for patients with ductal carcinoma in situ (DCIS) and early invasive breast cancer.
- To determine patient-reported functional status and breast pain using the BCTOS at 6 months, 1, 2, 3, 4, and 5 years after treatment.
VI. To determine maximal acute (within 6 weeks of treatment) and late (more than 6 weeks after treatment) skin and soft tissue toxicities using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)4.0 scale.
VII. To determine the relationship between the volume of breast tissue receiving excessive dose (defined as greater than 105% of the prescription dose) and the risk of adverse cosmesis.
VIII. To determine the relationship between bra cup size and the risk of adverse cosmesis.
IX. To determine whether there is a statistical interaction between breast volume and volume of tissue receiving greater than 105% of the prescription dose in predicting adverse cosmesis.
- To determine in an exploratory analysis whether any other demographic, clinical, and pathologic factors correlate with risk of adverse cosmesis, quality of life, body image, image investment, and risk of IBTR.
XI. To determine if the C-509T variant allele of transforming growth factor-beta (TGF-beta) is associated with an increased risk of grade 2 or higher fibrosis (as determined by the Subjective, Objective, Medical Management, Analytic [SOMA] scale) three years after completion of radiation.
XII. To compare the cost of radiation for patients treated on the two treatment arms.
XIII. To compare patient quality of life, body image, and appearance investment for the two treatment arms using the Functional Assessment of Cancer Therapy-Breast (FACT-B), Appearance Schemas Inventory-Revised (ASI-R), and Body Image Scale, respectively.
XIV. To contribute additional blood samples to protocol LAB02-086 which is a case-control study investigating deoxyribonucleic acid (DNA) repair phenotypes and genotypes in breast cancer.
XV. To assess the psychometric profile of the Functional Assessment of Cancer Therapy-Breast (FACT-B) version 4 in collaboration with investigators from the Department of Medical Social Science, Northwestern University Feinberg School of Medicine.
XVI. To determine the influence of oncoplastic lumpectomy on the following outcomes: physician- and patient-reported cosmetic outcomes, other patient-reported health-related quality of life outcomes, and photographic measurements of breast cosmetic outcome.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo HF-WBI comprising external beam RT 5 days a week for approximately 3 weeks.
ARM II: Patients undergo CF-WBI comprising external beam RT 5 days a week for approximately 5 weeks.
After completion of study treatment, patients are followed up at 6 months and then annually for 5 years.
- Conditions
- Ductal Breast Carcinoma In Situ, Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v6, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7
- Being tested
- External Beam Radiation Therapy, Hypofractionated Radiation Therapy, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Questionnaire Administration
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Beam Radiation TherapyRadiation
Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy
Undergo HF-WBI
External Beam Radiation TherapyRadiation
Also called Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy
Undergo CF-WBI
Hypofractionated Radiation TherapyRadiation
Also called Hypofractionated Radiotherapy, hypofractionation
Undergo HF-WBI
Laboratory Biomarker AnalysisOther
Optional correlative studies
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
Whole Breast IrradiationRadiation
Undergo HF-WBI
Whole Breast IrradiationRadiation
Undergo CF-WBI
| Study group | Role | What they receive |
|---|---|---|
| Arm I (HF-WBI) | Experimental | Patients undergo HF-WBI comprising external beam RT 5 days a week for approximately 3 weeks. Receives: Radiation: External Beam Radiation Therapy; Radiation: Hypofractionated Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Whole Breast Irradiation |
| Arm II (CF-WBI) | Active comparator | Patients undergo CF-WBI comprising external beam RT 5 days a week for approximately 5 weeks. Receives: Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Whole Breast Irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Scores of Either <2.5 or >=2.5 on the Breast Cancer Treatment Outcome Scale (BCTOS) Cosmesis
BCTOS cosmesis score range from 1 to 4, and scores of 2.5 or more indicate adverse cosmetic outcomes.
Measured: 3 years after completing radiation therapy
Secondary outcomes (1)
Panel Physicians Rated Cosmesis
A group of three attending physicians blinded to the treatment scored the photographs using the Radiation Therapy and Oncology Group (RTOG) criteria. RTOG scale range from 1 (excellent), 2 (good), 3 (fair), and 4 (poor).
Measured: 3 years after completing radiation therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2010 (estimated)
- Study start8 Feb 2011
- Primary completion30 Nov 2020
- Study completion30 Nov 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ductal Breast Carcinoma In SituStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Benjamin D Smith, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01266642
- Sponsor's protocol ID
- 2010-0559
- Other IDs
- NCI-2011-00253, 2010-0559
- Status last verified
- Aug 2026
- First submitted
- 20 Dec 2010
- Last updated
- 17 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Weng JK, Lei X, Schlembach P, Bloom ES, Shaitelman SF, Arzu IY, Chronowski G, Dvorak T, Grade E, Hoffman K, Perkins G, Reed VK, Shah SJ, Stauder MC, Strom EA, Tereffe W, Woodward WA, Hortobagyi GN, Hunt KK, Buchholz TA, Smith BD. Five-Year Longitudinal Analysis of Patient-Reported Outcomes and Cosmesis in a Randomized Trial of Conventionally Fractionated Versus Hypofractionated Whole-Breast Irradiation. Int J Radiat Oncol Biol Phys. 2021 Oct 1;111(2):360-370. doi: 10.1016/j.ijrobp.2021.05.004. Epub 2021 May 13.
PubMed 33992718Grossberg AJ, Lei X, Xu T, Shaitelman SF, Hoffman KE, Bloom ES, Stauder MC, Tereffe W, Schlembach PJ, Woodward WA, Buchholz TA, Smith BD. Association of Transforming Growth Factor beta Polymorphism C-509T With Radiation-Induced Fibrosis Among Patients With Early-Stage Breast Cancer: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2018 Dec 1;4(12):1751-1757. doi: 10.1001/jamaoncol.2018.2583.
PubMed 30027292Shaitelman SF, Schlembach PJ, Arzu I, Ballo M, Bloom ES, Buchholz D, Chronowski GM, Dvorak T, Grade E, Hoffman KE, Kelly P, Ludwig M, Perkins GH, Reed V, Shah S, Stauder MC, Strom EA, Tereffe W, Woodward WA, Ensor J, Baumann D, Thompson AM, Amaya D, Davis T, Guerra W, Hamblin L, Hortobagyi G, Hunt KK, Buchholz TA, Smith BD. Acute and Short-term Toxic Effects of Conventionally Fractionated vs Hypofractionated Whole-Breast Irradiation: A Randomized Clinical Trial. JAMA Oncol. 2015 Oct;1(7):931-41. doi: 10.1001/jamaoncol.2015.2666.
PubMed 26247543