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

  • End date
    Nov 1, 2022
  • participants needed
  • sponsor
    M.D. Anderson Cancer Center
Updated on 29 December 2021
ct scan
breast cancer
tumor cells
carcinoma in situ
carcinoma in situ of the cervix
invasive breast cancer
adenocarcinoma of the breast
ductal carcinoma in situ
axillary lymph node dissection
sentinel node
ductal carcinoma
sentinel lymph node biopsy
partial breast irradiation
breast irradiation


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.



I. To assess the cosmesis, acute toxicity and late toxicity in patients treated with accelerated partial breast irradiation delivered with proton radiation.


I. To evaluate the convenience of accelerated partial breast irradiation and quality of life during accelerated partial breast irradiation.

II. To estimate the in-breast tumor control rates in patients treated with accelerated partial breast irradiation delivered with proton radiation.

III. Compare dosimetry to alternate treatment modalities.


Within 10 weeks of last breast cancer surgery, patients undergo accelerated partial breast irradiation (APBI) delivered with proton radiation twice daily (BID) for 5 days.

After completion of study treatment, patients are followed up at 6 weeks, 6 months, 1 year, and 18 months, then annually for 10 years.

Condition Ductal Carcinoma In Situ, Ductal Carcinoma In Situ (DCIS), Breast Cancer, Breast Cancer, Invasive Breast Carcinoma, Invasive Breast Cancer, Adenocarcinoma of the Breast, Breast Adenocarcinoma, 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, Stage 0 Breast Cancer AJCC v6 and v7, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Ductal Carcinoma In Situ (DCIS), dcis, non-invasive breast carcinoma
Treatment quality-of-life assessment, Questionnaires, Proton Beam Radiation Therapy, Accelerated Partial Breast Irradiation (APBI), Proton Therapy System, Accelerated Partial Breast Irradiation
Clinical Study IdentifierNCT01245712
SponsorM.D. Anderson Cancer Center
Last Modified on29 December 2021


Yes No Not Sure

Inclusion Criteria

The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines
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 ductal carcinoma in situ (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); reexcision 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 less than or equal to 30% based on the postoperative/pre-enrollment computed tomography (CT) scan
Patients are eligible if, based on the postoperative CT scan, partial breast irradiation (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

Exclusion Criteria

Men are not eligible for this study
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 reexcision, the patient is eligible)
Clear delineation of the extent of the target lumpectomy cavity not possible
Treatment plan that includes regional nodal irradiation
Prior radiation to the index breast
Documented diagnosis of collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma
Pregnancy or lactation at enrollment
Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy
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