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A Study of Accelerated 3 Fraction Photon,Proton or Brachytherapy for Early Invasive and Noninvasive Breast Ca

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Robert Mutter, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02453737
First received: May 21, 2015
Last updated: December 8, 2016
Last verified: December 2016
  Purpose
This is an open label phase II study to determine the safety and efficacy of a novel 3 fraction daily dosing regimen for accelerated partial breast irradiation (APBI) for early invasive and noninvasive breast cancer. The three techniques utilized are recognized as standard options for the delivery of APBI, and there is no evidence that either technique is superior or inferior to any other. The APBI technique utilized will be at the physician's discretion and will be based on technical considerations, availability at the treating radiation facility, insurance coverage, as well as patient preference.

Condition Intervention Phase
Breast Cancer
Radiation: Brachytherapy APBI
Radiation: 3D-CRT (photon) APBI
Radiation: Proton APBI
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Accelerated 3 Fraction Photon and Proton Partial Breast External Beam Radiotherapy and Partial Breast Brachytherapy for Early Invasive and Noninvasive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Change in the rate of adverse cosmesis (defined as fair or poor cosmesis) compared to baseline [ Time Frame: Baseline, 3 years ]

Estimated Enrollment: 168
Study Start Date: June 2015
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Catheter-based brachytherapy APBI
7 Gy x 3 fractions
Radiation: Brachytherapy APBI
3D-CRT APBI
7.3 Gy x 3 fractions
Radiation: 3D-CRT (photon) APBI
Proton APBI
7.3 Gy x 3 fractions
Radiation: Proton APBI

  Eligibility

Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female Age ≥ 50 years at diagnosis
  • Grade 1-3 invasive ductal, mucinous, tubular, colloidal, or pure ductal carcinoma in situ (DCIS) measuring ≤ 2cm (clinical stage T1).
  • Estrogen Receptor (ER)+ (ER- DCIS meeting other eligibility criteria are eligible)
  • Unicentric: Patients with microscopic multifocality are eligible as long as the total pathologic tumor size is <2cm.
  • Surgical treatment of the breast must have been lumpectomy.
  • The final margins of the resected specimen must be histologically free of tumor.
  • Pathologically node negative Note: For patients with T1a, T1b, T1c invasive breast cancer (except T1mi), an axillary staging procedure should be performed (either sentinel lymph node biopsy alone or axillary dissection and the axillary node must be pathologically negative). Patients with N0 (i+) tumors on sentinel lymph node mapping or dissection (i.e., if the tumor deposit is 0.2mm or less as determined by immunohistochemistry or hematoxylin and eosin staining) will also be eligible.
  • ECOG Performance Status of 0 or 1
  • Negative pregnancy test done ≤7 days prior to registration, for women of childbearing potential only.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Ability to elect radiotherapy care in conjunction with their physician
  • Able and willing to provide written informed consent
  • Willingness to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willing to provide tissue and blood samples for correlative research purposes
  • Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136

Exclusion Criteria:

  • Any of the following because this study involves therapy that has known genotoxic, mutagenic and teratogenic effects:

    • Pregnant women
    • Nursing women
    • Women of childbearing potential who are unwilling to employ adequate contraception
  • Neoadjuvant chemotherapy
  • Prior history of ipsilateral breast cancer
  • Prior radiation therapy to the ipsilateral breast or thorax
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Active collagen-vascular disease that, in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient.
  • Paget's disease of the breast
  • Proven multicentric carcinoma (DCIS or invasive) in more than one quadrant or separated by 4 or more centimeters or diffuse (>1 quadrant) suspicious calcifications
  • Histologic evidence of angiolympatic invasion (ALI). Note: Cases termed focally suspicious for ALI but where no definitive ALI is found are eligible.
  • Surgical margins that cannot be microscopically assessed or that are positive
  • Pathologic tumor >2cm in size
  • Metastatic disease
  • Patients for whom the delivery of APBI is not feasible or any of the dosimetric treatment criteria in section 9.7 have not been met.
  • BRCA 1/2 mutation Note: Patients are not required to undergo BRCA1 and BRCA2 or other genetic mutation tests in order to enroll on the study. However, in the event a patient is tested and is found to be a mutation carrier, she would be excluded from the study.
  • Breast implants (patients who have had implants removed are eligible).
  • Extensive intraductal component
  • Active connective tissue disease
  • Reduction mammoplasty if 3DCRT or proton APBI are planned
  • Last surgery >10 weeks from enrollment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02453737

Contacts
Contact: Clinical Trials Referral Office 855-776-0015
Contact: Stephanie Gunderson 507-293-0171

Locations
United States, Arizona
Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States, 32224
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Clinical Trials Referral Office    855-776-0015      
Principal Investigator: Robert Mutter, MD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Robert Mutter, MD Mayo Clinic
  More Information

Responsible Party: Robert Mutter, Assistant Professor of Radiation Oncology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02453737     History of Changes
Other Study ID Numbers: 14-002566 
Study First Received: May 21, 2015
Last Updated: December 8, 2016

Keywords provided by Mayo Clinic:
Proton
Brachytherapy
Partial Breast Irradiation
3D Conformal Photon

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on February 20, 2017