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Clinical Trial NCT01758445 for Breast Cancer, Breast Neoplasm, Breast Tumor, Cancer of the Breast is active, not recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Proton Radiation for Stage II/III Breast Cancer Phase 2 220

Active, not recruiting
Clinical Trial NCT01758445 is designed to study Treatment for Breast Cancer, Breast Neoplasm, Breast Tumor, Cancer of the Breast. It is a Phase 2 interventional study that is active, not recruiting, having started on 1 February 2013, with plans to enroll 220 participants. Led by Proton Collaborative Group, it is expected to complete by 1 January 2032. The latest data from ClinicalTrials.gov was last updated on 4 September 2025.
Brief Summary
The purpose of this study is to look at the rates of acute and long term adverse events of postoperative proton radiotherapy for complex loco-regional irradiation in women with loco-regionally advanced breast cancer. This study specifically includes longitudinal follow up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15 years following proton therapy(PT).
Detailed Description
The proposed Phase II study is seeking to build clinical data as a continuation of the original dosimetric analysis published by Ares et al. performed at Paul-Scherrer Institute (PSI). That comparison demonstrated a benefit form proton planning for patients with non-metastatic breast cancer requiring complex, loco-regional, postoperative radiotherapy.1 The advantages of PT were improved target coverage compared to st...Show More
Official Title

Phase II Study of Postoperative, Cardiac-Sparing Proton Radiotherapy for Patients With Stage II/III,Loco-Regional, Non-Metastatic Breast Cancer Requiring Whole Breast or Chest Wall Irradiation With Lymph Node Irradiation

Conditions
Breast CancerBreast NeoplasmBreast TumorCancer of the Breast
Other Study IDs
  • BRE008-12
NCT ID Number
NCT01758445
Start Date (Actual)
2013-02
Last Update Posted
2025-09-04
Completion Date (Estimated)
2032-01
Enrollment (Estimated)
220
Study Type
Interventional
PHASE
Phase 2
Status
Active, not recruiting
Keywords
Breast
Cancer
Radiation
Proton
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalProton Radiotherapy
Proton Radiotherapy
Proton Radiotherapy
Radiation therapy will be given once a day. Minimum of 28 treatments and may receive 6-9 additional treatments as determined by protocol \& physician.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment.
5 years
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Compare dosimetrically the dose volume histogram (DVH) of the PT plans with conventional external beam plans (either photon/electron intensity modulated radiotherapy(IMRT)plans, 3D-photon plans, or Tomotherapy plans).
On average at 9 weeks post start of treatment
Incidence rates of local control, regional control, metastatic status and disease free overall survival.
5 years
Compare the different DVH parameters for the targets (D2, Dmean, Dmin, D95, V95, V110) and different OARs (as described later) of the PT plans with the corresponding values of the 3D-conformal radiation therapy (CRT), IMRT and Tomotherapy plans.
On average at 9 weeks post start of treatment
Determine dose distribution of proton therapy to coronary arteries, heart, ipsilateral and contralateral lung, and contralateral breast.
On average at 9 weeks post start of treatment
Determine the incidence of clinically symptomatic coronary artery disease, cardiac morbidity and mortality in general and incidence of secondary malignancy, including contralateral breast cancer
5 years
Evaluate quality of life results.
5 years
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
  2. Must be > = 18 years of age.
  3. Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
  4. Must have pathology proven breast cancer. Pathology must be invasive ductal or lobular
  5. Must meet stage II - III group criteria per AJCC Staging manual 7th edition.
  6. Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted.
  7. Note: Multicentric breast cancer and Paget's disease of the nipple are permitted.

  1. Weight over 410 pounds.
  2. Non-epithelial breast malignancies such as sarcoma or lymphoma.
  3. 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).
  4. Breast size exceeding the technical limitation of daily set-up reproducibility. This may be center-specific and will be assessed at the discretion of the treating center.
  5. Women with post-surgical temporary breast expanders will require individual assessment. Depending on the manufacturing product and other treatment planning-specific details the patient may be eligible or may be deemed ineligible, as determined by treating investigator.
  6. Prior history of breast cancer.
  7. Prior radiation to the breast or thorax.
  8. Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
  9. Pregnancy or lactation at the time of proposed study entry. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy such as an intrauterine device or condom with spermicide. (Note: Women of childbearing potential must have a negative serum pregnancy test within 3 weeks of study registration).
  10. Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
  11. Prior history of non-breast malignancies unless they have been disease free for 5 or more years and are deemed by their physician to be at low risk for recurrence. Further, patients who have the following cancers treated within the prior 5 years are permitted: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, basal cell or squamous cell carcinoma of the skin.
Proton Collaborative Group logoProton Collaborative Group
No contact data.
5 Study Locations in 1 Countries

Illinois

Northwestern Medicine Chicago Proton Center, Warrenville, Illinois, 60555, United States

Maryland

Maryland Proton Treatment Center, Baltimore, Maryland, 21201, United States

New Jersey

Princeton ProCure Managment LLC, Somerset, New Jersey, 08873, United States

Oklahoma

Oklahoma Proton Center, Oklahoma City, Oklahoma, 73142, United States

Virginia

Hampton University Proton Therapy Institute, Hampton, Virginia, 23666, United States