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MRI-Based Preoperative Accelerated Partial Breast Irradiation

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ClinicalTrials.gov Identifier: NCT02728076
Recruitment Status : Recruiting
First Posted : April 5, 2016
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Adam Currey, Medical College of Wisconsin

Tracking Information
First Submitted Date  ICMJE March 30, 2016
First Posted Date  ICMJE April 5, 2016
Last Update Posted Date November 8, 2019
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
Postoperative Complication Rates following Preoperative APBI [ Time Frame: 4 Months ]
Postoperative complications (the primary endpoint of the study) will be defined as any complication occurring within three months of surgery. These will be measured by CTCAE. The complication rate measured on this study will be compared to a historical control of 32% of patients. This will be measured on an individual patient level. A surgical complication rate that exceeds 31% will be considered unacceptable and result in a negative study. A postoperative complication rate of 14% or less will be considered a successful demonstration of the safety of this treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02728076 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • Cosmetic Outcomes [ Time Frame: 5 Years ]
    Cosmesis will be judged by the patient, radiation oncologist and/or surgeon, at stated follow-up intervals. Cosmetic assessments will be assessed using a 4-point scale.
  • Measure Rates of Fibrosis and Pain [ Time Frame: 5 Years ]
    Patient reported average and worst pain in the treated breast. Radiation Therapy Oncology Group (RTOG) Late Radiation Morbidity Scoring Scheme, rate of Grade 2+ subcutaneous fibrosis. (Statistics: Kaplan-Meier survival estimates or estimate of the cumulative incidence rate will be used where censoring or competing risks occur (local control, cosmetic outcomes, fibrosis, and pain).)
  • Rates of Re-excision [ Time Frame: 5 Years ]
    The need for surgical re-excision after the initial lumpectomy because of close or positive margins will be determined by the treating surgeon and radiation oncologist. For any patient with a positive margin, re-excision is required unless technically not possible (i.e. poor anesthesia risk for the patient, inability to resect additional breast tissue at the site of the positive margin). The re-excision rate and rate of partial/complete response with be estimated with exact confidence intervals, and compared to historical controls using Chi-Square or Fisher's exact tests.
  • Overall Survival [ Time Frame: 5 Years ]
    A final analysis will occur when all patients have been followed up for five years. Record long term outcomes of local recurrence rates and overall survival of patients treated with this modality.
  • Feasibility of MRI-based Treatment Planning [ Time Frame: 5 Years ]
    Demonstrate the feasibility of MRI-based treatment planning for preoperative APBI and compare dosimetric data from treatment planning with patients treated on a previous institutional post-op APBI protocol.
  • Local Control [ Time Frame: 5 Years ]
    Local tumor control defined as reappearance of the tumor in the ipsilateral breast.
  • Radiologic and Pathologic Response [ Time Frame: 5 Years ]
    Tumor response will be assessed using the RECIST and mRECIST criteria.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MRI-Based Preoperative Accelerated Partial Breast Irradiation
Official Title  ICMJE Phase II Study of MRI-Based Preoperative Accelerated Partial Breast Irradiation
Brief Summary This study examines the feasibility to deliver accelerated partial breast irradiaiton (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-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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Radiation: Phase II - Preoperative Radiation followed by Lumpectomy.
Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.
Study Arms  ICMJE Experimental: Radiation Therapy followed by Lumpectom
Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy
Intervention: Radiation: Phase II - Preoperative Radiation followed by Lumpectomy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 30, 2016)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II.
  • Female
  • Age ≥50 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.
  • CBC/differential obtained within 14 days prior to study entry, with adequate bone marrow function defined as follows: Absolute neutrophil count ≥ 1,800 cells/mm3; Platelets ≥ 75,000 cells/mm3; 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 ASCO/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:

  • 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 (see section 3.1.13), 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 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 MCW 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 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 6 months;
    • Transmural myocardial infarction within the last 6 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Medical College of Wisconsin Cancer Center 414-805-8900 cccto@mcw.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02728076
Other Study ID Numbers  ICMJE PRO26847
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adam Currey, Medical College of Wisconsin
Study Sponsor  ICMJE Medical College of Wisconsin
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adam Currey, MD Medical College of Wisconsin
PRS Account Medical College of Wisconsin
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP