Clinical Trials /

MRI-Based Preoperative Accelerated Partial Breast Irradiation

NCT02728076

Description:

This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks after completion of the APBI, the cancer will be surgically removed.

Related Conditions:
  • Breast Invasive Ductal Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: MRI-Based Preoperative Accelerated Partial Breast Irradiation
  • Official Title: Phase II Study of MRI-Based Preoperative Accelerated Partial Breast Irradiation

Clinical Trial IDs

  • ORG STUDY ID: PRO26847
  • NCT ID: NCT02728076

Conditions

  • Breast Cancer

Purpose

This study examines the feasibility to deliver accelerated partial breast irradiation (APBI) before a lumpectomy is performed. By administering the APBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The APBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an X-ray beam to deliver the radiation dose. Traditionally, CT imaging is used to plan treatment. In this study, an MRI will be used. Approximately five to eight weeks after completion of the APBI, the cancer will be surgically removed.

Detailed Description

      This study will examine the feasibility, complication rates, cosmetic results and local
      control rate of 3D conformal radiation therapy (CRT) confined to the region of the lumpectomy
      cavity for patients with Stage I and IIa (less than or equal to 3 cm) carcinoma of the breast
      (non-lobular histology) treated with APBI using 3D-CRT before lumpectomy. This study also
      will test the feasibility of MRI-based treatment planning for preoperative accelerated
      partial breast irradiation and compare dosimetric data from treatment planning with patients
      treated on a previous institutional post-op APBI protocol. It will also look at overall
      survival rates. Correlative studies include measuring the changes in tumor gene expression
      and immune response to radiation therapy and correlate this with pathologic response.
    

Trial Arms

NameTypeDescriptionInterventions
Radiation Therapy followed by LumpectomExperimentalPhase II-Preoperative MRI-BasedRadiation followed by Lumpectomy

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.
    
              -  Female
    
              -  Age ≥40 years
    
              -  Estrogen receptor positive
    
              -  Patients with both her2 positive and her2 negative tumors are eligible
    
              -  Unifocal disease
    
              -  Invasive ductal carcinoma diagnosed by core needle biopsy
    
              -  Clinically node negative both by physical exam and by ultrasound. All enlarged or
                 abnormal appearing lymph nodes must be biopsied.
    
              -  Zubrod performance status 0-2
    
              -  Study entry must be within 120 days from initial diagnosis of breast cancer.
    
              -  Complete blood count (CBC) /differential obtained within 14 days prior to study entry,
                 with adequate bone marrow function defined as follows: Absolute neutrophil count ≥
                 1,800 cells/mm^3; Platelets ≥ 75,000 cells/mm^3; Hemoglobin ≥8.0g/dl.
    
              -  Not pregnant or lactating; willing to use acceptable forms of contraception during
                 radiation therapy.
    
              -  Prior breast augmentation, including breast implants, is allowed.
    
              -  Patients with a prior history of contralateral breast cancer will be considered
                 eligible if they completed all treatment (including anti-endocrine therapy) more than
                 five years prior to registration.
    
              -  Patients must not have a prior treatment of malignancy diagnosed or treated within the
                 past five years, with the exception of non-melanomatous skin cancer, carcinoma in situ
                 of the cervix and contralateral breast cancer.
    
              -  Interested patients must meet with a medical oncologist prior to study entry to
                 determine if Oncotype testing is recommended. If recommended and patient is amenable
                 to the possibility of receiving chemotherapy, there must be adequate biopsy tissue for
                 testing. If adequate tissue is not available for the Oncotype testing, patients who
                 are very interested in participation may undergo additional biopsies. If a patient
                 plans to refuse chemotherapy regardless of a high Oncotype results and elects to forgo
                 the test, they will still be eligible for enrollment.
    
              -  Patients must have had estrogen and progesterone receptor analysis performed on the
                 biopsy specimen prior to study entry according to current American Society of Clinical
                 Oncology (ASCO) / College of American Pathologists (CAP) Guideline Recommendations for
                 hormone receptor testing. Testing for her2 neu expression must also be performed and
                 recorded prior to study entry.
    
              -  Appropriate stage and pre-treatment evaluation for protocol entry, including no
                 clinical evidence for distant metastases, based upon the following minimum diagnostic
                 workup:
    
                   -  History/Physical examination, including breast exam (inspection and palpation of
                      the breasts) with documentation of weight and Zubrod Performance Status of 0-2
                      within 28 days prior to study entry.
    
                   -  Right and left mammography within 60 days of diagnostic biopsy establishing
                      diagnosis.
    
                   -  Evaluation of the axilla by ultrasound and biopsy of all enlarged or abnormal
                      appearing lymph nodes within 28 days prior to study entry.
    
                   -  Clip placed within the biopsy proven breast cancer, with verification of
                      placement by mammogram.
    
            Exclusion Criteria:
    
              -  American Joint Committee on Cancer (AJCC) clinical T3, N1-3, M1, stage IIB, stage III
                 or stage IV breast cancer
    
              -  Prior invasive non-breast malignancy (exceptions include non-melanomatous skin cancer,
                 carcinoma in situ of the cervix, or prior contralateral breast cancer as described in
                 3.1.11) unless disease free and off treatment for a minimum of five years prior to
                 study entry.
    
              -  Multifocal breast cancer
    
              -  Modified Bloom-Richardson grade 3 disease
    
              -  Estrogen receptor negative disease
    
              -  Lymphovascular space invasion noted on biopsy
    
              -  Invasive lobular carcinoma
    
              -  Purely non-invasive breast cancer (i.e. ductal carcinoma in situ, lobular carcinoma in
                 situ)
    
              -  Non-epithelial breast malignancies such as sarcoma or lymphoma
    
              -  Paget's disease of the nipple
    
              -  Male breast cancer
    
              -  Prior history of radiation therapy to the chest in the region of the ipsilateral
                 breast that would result in overlap of radiation fields.
    
              -  Patients having received or having planned neoadjuvant chemotherapy or concurrent
                 chemotherapy. A recommendation for adjuvant chemotherapy will not preclude
                 eligibility. However, if a patient has an Oncotype score that would lead to a
                 recommendation for systemic chemotherapy, and chemotherapy is planned to be given in
                 the neoadjuvant setting, the patient would then be ineligible for enrollment.
    
              -  Patients who are unable to undergo magnetic resonance imaging (MRI). This could
                 include patients with a severe allergy to gadolinium contrast or patients with renal
                 function insufficient to receive contrast (GFR less than 30). Patients who have a
                 minor allergy (for example, skin rash or hives) to gadolinium contrast may still be
                 considered for enrollment. These patients would have to receive prophylactic
                 prednisone and diphenhydramine per Medical College of Wisconsin Department of
                 Radiology protocol. Such cases should be reviewed with the principal investigator and
                 radiology co-chair prior to enrollment.
    
              -  History of connective tissue disorder, including lupus, dermatomyositis and
                 scleroderma.
    
              -  Zubrod performance status of 3 or greater
    
              -  Known breast cancer gene (BRCA) mutation
    
              -  Medical, psychiatric or other condition that would prevent the patient from receiving
                 the protocol therapy or providing informed consent.
    
              -  Patients, who under the best estimates of the treating radiation oncologist, have a
                 life expectancy of 10 years or less.
    
              -  Patients who are pregnant.
    
              -  Severe, active co-morbidity, defined as follows:
    
                   -  Unstable angina and/or congestive heart failure requiring hospitalization within
                      the last six months;
    
                   -  Transmural myocardial infarction within the last six months;
    
                   -  Acute bacterial or fungal infection requiring intravenous antibiotics at the time
                      of registration;
    
                   -  Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness
                      requiring hospitalization or precluding study therapy within 30 days before
                      registration;
    
                   -  Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects;
                      note, however, that laboratory tests for liver function and coagulation
                      parameters are not required for entry into this protocol
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:40 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Postoperative complications following
    Time Frame:3 Months
    Safety Issue:
    Description:The number of subjects with one or more postoperative complications following preoperative accelerated partial breast irradiation within three months of surgery.

    Secondary Outcome Measures

    Measure:Re-excision of tumor.
    Time Frame:5 Years
    Safety Issue:
    Description:Number of subjects with re-excision following surgery.
    Measure:Overall Survival
    Time Frame:5 Years
    Safety Issue:
    Description:The number of patients alive at five years.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Active, not recruiting
    Lead Sponsor:Medical College of Wisconsin

    Trial Keywords

    • Breast Cancer
    • Accelerated Partial Breast Irradiation

    Last Updated

    July 21, 2021