Hypofractionated Radiation Therapy or Standard Radiation Therapy in Treating Patients With Ductal Breast Carcinoma In Situ or Early Invasive Breast Cancer

NCT01266642 | Active Not Recruiting Phase 2 Results FDA Drug

• 2 other identifiers: 2010-0559NCI-2011-00253
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 7

Brief 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. 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.

Conditions

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; Stage IIA Breast Cancer AJCC v6 and v7; Stage IIB Breast Cancer AJCC v6 and v7; Ductal Breast Carcinoma In Situ

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years after completing radiation therapy

Secondary Outcomes (1)

• Panel Physicians Rated Cosmesis

  3 years after completing radiation therapy.

Study Arms (2)

Arm I (HF-WBI)

EXPERIMENTAL

Patients undergo HF-WBI comprising external beam RT 5 days a week for approximately 3 weeks.

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.

Radiation: External Beam Radiation Therapy; Other: Laboratory Biomarker Analysis; Other: Quality-of-Life Assessment; Other: Questionnaire Administration; Radiation: Whole Breast Irradiation

Interventions

External Beam Radiation Therapy RADIATION

Undergo HF-WBI

Also known as: Definitive Radiation Therapy, EBRT, External Beam Radiation, External Beam Radiotherapy, External Beam RT, external radiation, External Radiation Therapy, external-beam radiation, Radiation, External Beam

Arm I (HF-WBI)

Hypofractionated Radiation Therapy RADIATION

Undergo HF-WBI

Also known as: Hypofractionated Radiotherapy, hypofractionation

Arm I (HF-WBI)

Laboratory Biomarker Analysis OTHER

Optional correlative studies

Arm I (HF-WBI); Arm II (CF-WBI)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (HF-WBI); Arm II (CF-WBI)

Questionnaire Administration OTHER

Ancillary studies

Arm I (HF-WBI); Arm II (CF-WBI)

Whole Breast Irradiation RADIATION

Undergo HF-WBI

Arm I (HF-WBI)

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (7)

Banner MD Anderson Cancer Center

Gilbert, Arizona, 85234, United States

Location

UF Cancer Center at Orlando Health

Orlando, Florida, 32806, United States

Location

MD Anderson in The Woodlands

Conroe, Texas, 77384, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MD Anderson West Houston

Houston, Texas, 77079, United States

Location

MD Anderson League City

League City, Texas, 77573, United States

Location

MD Anderson in Sugar Land

Sugar Land, Texas, 77478, United States

Location

Related Publications (3)

• 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.

  PMID: 33992718 DERIVED

• Grossberg 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.

  PMID: 30027292 DERIVED

• Shaitelman 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.

  PMID: 26247543 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

Interventions

Radiation; Radiation Dose Hypofractionation

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Results Point of Contact

• Title: Dr. Benjamin Smith, Professor, Radiation Oncology Department
• Organization: UT MD Anderson Cancer Center

bsmith3@mdanderson.org

(713) 563-2380

Study Officials

• Benjamin D Smith

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: December 24, 2010
• Study Start: February 8, 2011
• Primary Completion: November 30, 2020
• Study Completion (Estimated): November 30, 2040
• Last Updated: March 11, 2026
• Results First Posted: November 19, 2021

Record last verified: 2026-02

Locations

US (7)