Radiation Therapy in Treating Patients With Stage 0-II Breast Cancer

NCT01245712 | Active Not Recruiting Phase 2

• 2 other identifiers: 2009-0818NCI-2011-01102
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies the side effects and how well radiation therapy works in treating patients with stage 0-II breast cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

Conditions

Breast Adenocarcinoma; Ductal Breast Carcinoma In Situ; Invasive Breast Carcinoma; Stage 0 Breast Cancer AJCC v6 and v7; Stage I Breast Cancer AJCC v7; 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

Outcome Measures

Primary Outcomes (1)

• Patient-Reported Cosmesis Score

  Patient-reported cosmesis score on the Breast Cancer Treatment Outcomes Scale (BCTOS) at 1 year. Cosmesis scores range from 1 (excellent) to 4 (poor), and scores of 3 (fair) or more indicate adverse cosmetic outcomes.

  1 year

Secondary Outcomes (2)

• Rate of CTCAE Grade 3+ Confluent Moist Desquamation

  Within 6 weeks of radiation therapy

• Percent of Patients with Local Failure

  10 years

Study Arms (1)

Treatment (APBI)

EXPERIMENTAL

Within 10 weeks of last breast cancer surgery, patients undergo APBI delivered with proton radiation BID for 5 days.

Radiation: Accelerated Partial Breast Irradiation; Radiation: Proton Beam Radiation Therapy; Other: Quality-of-Life Assessment

Interventions

Proton Beam Radiation Therapy RADIATION

Undergo APBI delivered with proton radiation

Also known as: PBRT, Proton Radiation Therapy

Treatment (APBI)

Accelerated Partial Breast Irradiation RADIATION

Undergo APBI delivered with proton radiation

Also known as: APBI

Treatment (APBI)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (APBI)

Eligibility Criteria

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

You may qualify if:

• Women who satisfy all of the following conditions are the only patients who will be eligible for this study.
• The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
• Patients must be \>/= 18 years old. (Adenocarcinoma of the breast is not seen in children)
• English and non-English speaking patient
• The patient must have stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
• On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
• Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive).
• Re-excision of surgical margins is permitted.
• Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)
• Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is not required for patients with DCIS.
• The target lumpectomy cavity must be clearly delineated and the target lumpectomy cavity/whole breast reference volume must be \< 30% based on the postoperative/pre-enrollment CT scan.
• Patients are eligible if, based on the postoperative CT scan, PBI is judged to be technically deliverable.
• Patients with a history of non-breast malignancies are eligible if they have been disease-free for 5 or more years prior to enrollment and are deemed by their physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.

You may not qualify if:

• Women with one or more of the following conditions also are ineligible for this study.
• Men are not eligible for this study.
• Individuals that are considered to be cognitively impaired.
• T2 (\> 3.0 cm), T3, stage III, or stage IV breast cancer.
• More than 3 histologically positive axillary nodes.
• Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.
• Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes at time of enrollment unless there is histologic confirmation that these nodes are negative for tumor.
• Suspicious microcalcifications, or densities (in the ipsilateral or contralateral breast as documented on mammogram or breast ultrasound) unless biopsied and found to be benign.
• Non-epithelial breast malignancies such as sarcoma or lymphoma.
• Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters.
• Paget's disease of the nipple.
• Synchronous bilateral invasive or non-invasive breast cancer.
• Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible.)
• Clear delineation of the extent of the target lumpectomy cavity not possible.
• Treatment plan that includes regional nodal irradiation.

Sponsors & Collaborators

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

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Carcinoma In Situ; Breast Neoplasms

Interventions

Proton Therapy; Protons

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Radiotherapy; Therapeutics; Cations, Monovalent; Cations; Ions; Electrolytes; Inorganic Chemicals; Hydrogen; Elements; Gases; Nucleons; Elementary Particles; Physical Phenomena

Study Officials

• Melissa Mitchell, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 22, 2010
• Study Start: November 15, 2010
• Primary Completion (Estimated): December 31, 2032
• Study Completion (Estimated): December 31, 2032
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

US (1)