Clinical Trials /

Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

NCT01766297

Description:

The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy. This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
  • Official Title: Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: BRE007-12
  • NCT ID: NCT01766297

Conditions

  • Breast Cancer
  • Breast Neoplasm
  • Breast Tumor
  • Cancer of the Breast

Purpose

The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy. This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.

Detailed Description

      Current standard of care for early stage breast cancer is mastectomy or breast conserving
      therapy with whole breast irradiation following lumpectomy. However, studies of breast cancer
      recurrence have demonstrated the majority of tumors to recur in or adjacent to the original
      tumor site. The question has thus been raised as to whether radiation to the whole breast is
      necessary or justified. Limiting radiation to the area of the original tumor may reduce acute
      and long-term skin and organ toxicities while making radiation therapy more convenient and
      less expensive. Several clinical trials are underway comparing partial breast irradiation
      (PBI) to whole breast irradiation. Numerous centers are offering partial breast irradiation
      outside of clinical trials as well, despite the lack of long-term safety and efficacy data on
      PBI.

      Available PBI methods include brachytherapy, in which catheters or balloons are surgically
      inserted to deliver radiation therapy to the lumpectomy cavity, and conventional external
      beam radiation therapy, or EBRT. External beam photon therapy is attractive for its
      non-invasive nature and ability to deliver a more homogenous dose distribution compared to
      brachytherapy, however it also delivers a greater radiation dose to surrounding normal breast
      tissue.Proton therapy has the capacity to provide the same advantages as photon EBRT while
      minimizing dose to normal surrounding tissue. Clinical data on PBI with protons is minimal,
      however, leaving many questions unanswered. The impetus behind this protocol is to address
      these gaps by further investigating the feasibility, safety, and efficacy of proton therapy
      for partial breast irradiation.
    

Trial Arms

NameTypeDescriptionInterventions
Proton RadiotherapyExperimentalProton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose

    Eligibility Criteria

            Inclusion Criteria:
    
              -  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 female.
    
              -  Must be > = 50 years of age.
    
              -  Must have a life expectancy of at least 5 years based on age and co-morbidities.
    
              -  Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or
                 ductal carcinoma in situ (DCIS).
    
              -  One of the following criteria must be met: (a) Tumors that are microscopically
                 multifocal must be 3.0 cm or less in total aggregate size and encompassed within a
                 single scar (b) Patient does not have microscopically multifocal tumor.
    
              -  For tumors that are invasive, if in the presence of extensive intraductal component
                 (EIC), the entire pathologic tumor size (including both the intraductal and invasive
                 component) must be 3.0 cm or less.
    
              -  Must be Stage 0, I, II (Tis, T1, or T2, N0, M0 per AJCC criteria 7th and/or 8th Ed.).
                 If stage II, the tumor size must be < = 3.0 cm. A patient with invasive histology must
                 have nodal stage pN0 by H&E stains on sentinel node biopsy or axillary lymph node
                 dissection.
    
              -  Must have ER positive disease with ER/PR report available.
    
              -  For tumors that are invasive, HER2 must be performed (positive or negative is
                 acceptable).
    
              -  Must have a lumpectomy performed, with documented negative surgical margins by 0.2 cm
                 or more. If re-excision results in negative surgical margins 0.2 cm or more, patient
                 is eligible.
    
              -  If image guidance with daily cone beam CT with direct physician visual assessment is
                 used for treatment positioning, the presence of markers or clips in the surgical bed
                 is recommended but not required. If cone beam CT imaging will NOT be used for image
                 guidance, then the patient must be prepared to have 2 fiducial markers minimum, 3
                 preferred, placed prior to treatment (if not previously done).
    
                   -  If markers or clips were placed at the time of surgery, patient must be able to
                      start treatment within 12 weeks after lumpectomy or re-excision for adequate
                      margins.
    
                   -  If markers were not placed at the time of surgery and are needed, patient must
                      have markers placed within 6 weeks after surgery.
    
                   -  If systemic chemotherapy was given, patient must have had clips or markers placed
                      at the time of surgery (if they are needed) and patient must have simulation
                      scans within 6 weeks of the completion of the chemotherapy.
    
              -  Must be able to start treatment within 12 weeks of surgery or 8 weeks of finalization
                 of chemotherapy.
    
            Exclusion Criteria:
    
              -  Previous history of ipsilateral invasive breast cancer or DCIS.
    
              -  Any clinical or radiographically suspicious nodes, unless biopsy proven benign.
    
              -  Non-epithelial malignancies such as sarcoma or lymphoma.
    
              -  Suspicious residual microcalcifications on mammography of either breast, unless
                 negative for malignancy on pathology.
    
              -  Multicentric or bilateral disease unless biopsy of the clinical abnormalities are
                 performed and result is negative.
    
              -  Lymphovascular space invasion (LVSI) on pathology specimen.
    
              -  Any previously treated breast carcinoma or synchronous breast carcinoma in ipsilateral
                 breast.
    
              -  Prior radiation therapy to the ipsilateral breast or thorax.
    
              -  Paget's disease of the nipple.
    
              -  Histologic examination showing invasive lobular histology.
    
              -  Skin involvement.
    
              -  Breasts technically unsatisfactory for radiation treatment upon the discretion of the
                 treating physician.
    
              -  Significant infection or other co-existing medical condition that would preclude
                 protocol therapy such as pregnancy, HIV/AIDS or collagen vascular diseases
                 specifically systemic lupus erythematosus, scleroderma, or dermatomyositis.
    
              -  Known BRCA 1 or BRCA 2 mutation.
    
              -  Pregnant or lactating.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:To assess events of freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor.
    Time Frame:At 3 years
    Safety Issue:
    Description:Freedom from failure (FFF): The events for FFF will be the first ipsilateral breast cancer recurrence. It is expected that less than 3% of patients will experience an ipsilateral breast cancer recurrence (FFF ≥ 97%). A recurrence rate of ≥ 10% (FFF ≤ 90%) is considered unacceptable. Therefore, the null hypothesis is the FFF of ipsilateral breast cancer recurrence is 90% or lower and the alternative hypothesis is that FFF of ipsilateral breast cancer is 97% or higher.

    Secondary Outcome Measures

    Measure:Assess number and severity of acute and long-term toxicity of partial breast irradiation using proton therapy for the treatment of early stage breast cancer.
    Time Frame:On average every 6 months for life
    Safety Issue:
    Description:
    Measure:To assess relationship between breast size and partial breast dosimetry.
    Time Frame:Average every 6 months for 3 years
    Safety Issue:
    Description:
    Measure:Determine quality of life results.
    Time Frame:Average every 6 months for 3 years
    Safety Issue:
    Description:
    Measure:To determine overall survival rate of patients with breast cancer treated with proton radiation.
    Time Frame:At 3 years
    Safety Issue:
    Description:
    Measure:To determine recurrence pattern of patients with breast cancer treated with proton partial breast irradiation.
    Time Frame:At 3 years
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Proton Collaborative Group

    Trial Keywords

    • Breast Cancer
    • Proton
    • Radiation

    Last Updated

    January 16, 2018