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Proton beam radiation aims to spare healthy tissue in breast cancer treatment

NCT ID NCT01245712

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Nov 2010

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Female participants only

Healthy volunteers

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

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

  • M D Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.