Proton Radiation for Stage II/III Breast Cancer

NCT01758445 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: BRE008-12
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 5

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).

Conditions

Breast Cancer; Breast Neoplasm; Breast Tumor; Cancer of the Breast

Keywords

Breast; Cancer; Radiation; Proton

Outcome Measures

Primary Outcomes (1)

• Determination of the rates of acute and late toxicities (acute and late adverse events) resulting from proton therapy radiation treatment.

  5 years

Secondary Outcomes (6)

• 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

Study Arms (1)

Proton Radiotherapy

EXPERIMENTAL

Proton Radiotherapy

Radiation: Proton Radiotherapy

Interventions

Proton Radiotherapy RADIATION

Radiation therapy will be given once a day. Minimum of 28 treatments and may receive 6-9 additional treatments as determined by protocol \& physician.

Proton Radiotherapy

Eligibility Criteria

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

You may qualify if:

• 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.
• Must be \> = 18 years of age.
• Must have a life expectancy of at least 10 years based on age and comorbidities but excluding diagnosis of breast cancer.
• Must have pathology proven breast cancer. Pathology must be invasive ductal or lobular
• Must meet stage II - III group criteria per AJCC Staging manual 7th edition.
• Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted.
• Note: Multicentric breast cancer and Paget's disease of the nipple are permitted.

You may not qualify if:

• Weight over 410 pounds.
• Non-epithelial breast malignancies such as sarcoma or lymphoma.
• 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).
• 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.
• 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.
• Prior history of breast cancer.
• Prior radiation to the breast or thorax.
• Collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma.
• 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).
• Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
• 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.

Sponsors & Collaborators

• Proton Collaborative Group: lead

Study Sites (5)

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, 60555, United States

Location

Maryland Proton Treatment Center

Baltimore, Maryland, 21201, United States

Location

Princeton ProCure Managment LLC

Somerset, New Jersey, 08873, United States

Location

Oklahoma Proton Center

Oklahoma City, Oklahoma, 73142, United States

Location

Hampton University Proton Therapy Institute

Hampton, Virginia, 23666, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Eugen Hug, MD

  Proton Collaborative Group

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: January 1, 2013
• Study Start: February 1, 2013
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2032
• Last Updated: September 4, 2025

Record last verified: 2025-09

Locations

US (5)