Clinical Trials /

Single Fraction High-Gradient Partial Breast Irradiation in Treating Patients With Low-Risk Stage 0-I Breast Cancer

NCT02076074

Description:

This phase I/II clinical trial studies the side effects of delivering radiation therapy in a single session instead of multiple treatments over several weeks and to see how well it works in treating patients with low-risk stage 0-I breast cancer. Partial-breast irradiation, a type of radiation therapy focused only to the part of the breast that has cancer in it, given at a lower dose than standard whole-breast radiation therapy. Single fraction high-gradient partial-breast irradiation may cause fewer side effects, help prevent breast cancer from coming back, and improve the appearance of the breast and quality of life of patients with breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Single Fraction High-Gradient Partial Breast Irradiation in Treating Patients With Low-Risk Stage 0-I Breast Cancer
  • Official Title: Evaluation of Single Fraction High-Gradient Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-Risk Stage 0 and I Breast Carcinoma

Clinical Trial IDs

  • ORG STUDY ID: 201401160
  • NCT ID: NCT02076074

Conditions

  • Breast Neoplasms

Purpose

This phase I/II clinical trial studies the side effects of delivering radiation therapy in a single session instead of multiple treatments over several weeks and to see how well it works in treating patients with low-risk stage 0-I breast cancer. Partial-breast irradiation, a type of radiation therapy focused only to the part of the breast that has cancer in it, given at a lower dose than standard whole-breast radiation therapy. Single fraction high-gradient partial-breast irradiation may cause fewer side effects, help prevent breast cancer from coming back, and improve the appearance of the breast and quality of life of patients with breast cancer.

Detailed Description

      This is a phase I/II study which will evaluate the complication rates, local control,
      cosmetic results, and quality of life of single fraction high gradient partial breast
      irradiation (HG-PBI) when used as the sole method of radiation therapy for patients with
      pathologic stage 0 (=< 2 cm) or I carcinoma of the breast treated with partial mastectomy
      with histologically assessed negative surgical margins.
    

Trial Arms

NameTypeDescriptionInterventions
Treatment (HG-PBI)ExperimentalPatients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed
                 carcinoma of the breast, treated with partial mastectomy. Axillary sampling is
                 required only for cases of invasive cancers. Tumor size is determined by the
                 pathologist. Clinical size may be used if the pathologic size is indeterminate.
                 Patients with invasive cancer must have no positive axillary lymph nodes with at least
                 6 axillary lymph nodes sampled or a negative sentinel node.
    
              -  Negative histologic margins of partial mastectomy or re-excision specimen. Margins
                 generally are positive if there is invasive or noninvasive tumor at the inked
                 resection margin, close but negative if the tumor is within 2 mm of the inked margin
                 and negative if the tumor is at least 2 mm away from the inked edge.
    
              -  Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular
                 histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen or progesterone
                 receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma
                 in situ (lesions ≤ 2 cm).
    
              -  Systemic therapy, if planned, must be adjuvant in nature and not be scheduled to begin
                 for at least 4 weeks after completion of HG-PBI.
    
              -  Good candidate for treatment per protocol in the judgment of the PI and/or treating
                 physician following simulation.
    
              -  Postmenopausal status.
    
              -  Age ≥ 50 years at diagnosis.
    
              -  Able to understand and willing to sign IRB-approved written informed consent document.
    
              -  English speaker.
    
            Exclusion Criteria:
    
              -  Presence of distant metastases.
    
              -  In situ lobular carcinoma or nonepithelial breast malignancies such as sarcoma or
                 lymphoma.
    
              -  Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors
                 separated by at least 4 cm) with other clinically or radiographically suspicious areas
                 in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
    
              -  Premenopausal status.
    
              -  Histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable
                 or radiographically suspicious contralateral axillary, supraclavicular,
                 infraclavicular, or internal mammary nodes, unless there is histologic confirmation
                 that these nodes are negative for tumor.
    
              -  Prior non-hormonal therapy for the present breast cancer, including radiation therapy
                 or chemotherapy.
    
              -  Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.
    
              -  Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years.
    
              -  Diagnosis of psychiatric or addictive disorders that would preclude obtaining informed
                 consent.
    
              -  History of other malignancy ≤ 5 years previous with the exception of basal cell or
                 squamous cell carcinoma of the skin which were treated with local resection only or
                 carcinoma in situ of the cervix.
    
              -  Paget's disease of the nipple.
    
              -  Skin involvement, regardless of tumor size.
    
              -  Unsatisfactory breast for HG-PBI as determined by the treating physician. For example,
                 if there is little breast tissue remaining between the skin and pectoralis muscle
                 after surgery, treatment with HG-PBI is technically problematic.
    
              -  Partial mastectomy so extensive that the cosmetic result is fair or poor prior to
                 HG-PBI as determined by the treating physician.
    
              -  Surgical margins which cannot be microscopically assessed or are positive at
                 pathological evaluation.
    
              -  Time between final definitive breast procedure to HG-PBI simulation is greater than 8
                 weeks.
    
            Inclusion of Women and Minorities
    
            -Women and members of all races and ethnic groups are eligible for this trial. Because
            breast cancer occurs rarely in men, men will not be recruited for participation.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Proportion of patients who are free of serious treatment related toxicity
    Time Frame:Up to 5 years
    Safety Issue:
    Description:Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity per CTCAE, version 4.0

    Secondary Outcome Measures

    Measure:Proportion of patients who are free of breast cancer in the regional lymph nodes
    Time Frame:Up to 5 years
    Safety Issue:
    Description:Ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups. Calculated with a 95% confidence interval.
    Measure:Proportion of patients who are free from distant metastases
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Quality of life
    Time Frame:Up to 5 years
    Safety Issue:
    Description:Measured by the EORTC QLQ-C30, QLQ-BR23, and the Visual Analog Scale for Pain. Each of the subscales will be tabulated and presented graphically over the assessment times. Mixed repeated measures models will be generated to describe the nature of change in quality of life over time.
    Measure:Cosmesis as measured quantitatively
    Time Frame:Up to 5 years
    Safety Issue:
    Description:BRA and pBRA scores are calculated. pBRA scores will be plotted at the assessment time points and presented graphically.
    Measure:Cosmesis as measured qualitatively
    Time Frame:Up to 5 years
    Safety Issue:
    Description:Using the Aronson modified Harris scale. Assessed by patients and physicians. The two sets of scores will be plotted using histograms. Kappa statistics with 95% confidence intervals will be calculated to assess the agreement between patient and physician scores before treatment, at 4-6 months at 1 year, and at subsequent visits.
    Measure:Proportion of patients surviving
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Presence of complications using CTCAE v. 4.0
    Time Frame:Up to 5 years
    Safety Issue:
    Description:Complications will be tabulated and frequencies presented graphically.
    Measure:Frequency of any grade 3-4 toxicities using CTCAE v4.0
    Time Frame:Up to 5 years
    Safety Issue:
    Description:
    Measure:Proportion of patients undergoing mastectomy
    Time Frame:Up to 5 years
    Safety Issue:
    Description:The rate of mastectomy within five years of HG-PBI treatment will be calculated with a 95% confidence interval.

    Details

    Phase:Phase 1/Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Washington University School of Medicine

    Last Updated

    July 18, 2017