Proton beam radiation aims to spare healthy tissue in breast cancer treatment
NCT ID NCT01245712
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase II trial is testing a type of radiation called proton beam therapy for women with early-stage breast cancer (stage 0 to II). The goal is to see if this targeted approach can kill cancer cells while causing less damage to normal tissue, leading to fewer side effects and better cosmetic outcomes. About 200 women will receive the treatment and be followed for side effects and breast appearance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Proton beam radiation therapy
- What this could lead to
- If successful, this could offer a more precise radiation option for early breast cancer with fewer side effects and better cosmetic results.
- What could go wrong
- This is a phase II trial with 200 participants, so results are still preliminary. It may not prove better than standard radiation, and some skin reactions or other side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
200 people
The number who actually took part.
- Started
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Nov 2010
- Expected to finish
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Dec 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Women who satisfy all of the following conditions are the only patients who will be eligible for this study. 1. The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines. 2. Patients must be \>/= 18 years old. (Adenocarcinoma of the breast is not seen in children) 3. English and non-English speaking patient 4. The patient must have stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less. 5. On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast. 6. 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. 7. 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.) 8. 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. 9. 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. 10. Patients are eligible if, based on the postoperative CT scan, PBI is judged to be technically deliverable. 11. 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: Women with one or more of the following conditions also are ineligible for this study. 1. Men are not eligible for this study. 2. Individuals that are considered to be cognitively impaired. 3. T2 (\> 3.0 cm), T3, stage III, or stage IV breast cancer. 4. More than 3 histologically positive axillary nodes. 5. Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension. 6. 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. 7. Suspicious microcalcifications, or densities (in the ipsilateral or contralateral breast as documented on mammogram or breast ultrasound) unless biopsied and found to be benign. 8. Non-epithelial breast malignancies such as sarcoma or lymphoma. 9. Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters. 10. Paget's disease of the nipple. 11. Synchronous bilateral invasive or non-invasive breast cancer. 12. 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.) 13. Clear delineation of the extent of the target lumpectomy cavity not possible. 14. Treatment plan that includes regional nodal irradiation. 15. Prior radiation to the index breast 16. Documented diagnosis of collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma. 17. Pregnancy or lactation at enrollment. 18. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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