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Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02685332
Recruitment Status : Active, not recruiting
First Posted : February 18, 2016
Last Update Posted : March 12, 2021
Information provided by (Responsible Party):
Asal Rahimi, University of Texas Southwestern Medical Center

Brief Summary:
Radiation, Stereotactic Body Radiation Therapy.

Condition or disease Intervention/treatment Phase
Early Stage Breast Cancer Radiation: Stereotactic Radiation Phase 1

Detailed Description:
In this protocol, we plan to use the uniqueness of the Cyberknife system to deliver an adjuvant single fraction radiation dose. We anticipate that this radiation deliver system will reduce toxicity and improve cosmesis. Extrapolating from an intra-operative body of work, this Phase I study will attempt to achieve a non-invasive low toxicity profile and maintain good to excellent cosmesis. In this effort, the Cyberknife system will be used to achieve high conformality and dose gradient.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Dose Escalation Trial of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation (SB-PBI) For Early Stage Breast Cancer
Actual Study Start Date : March 31, 2016
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Stereotactic Radiation
Single Fraction Stereotactic Radiation. Cohort 1: 22.5 Gy Cohort 2: 25 Gy Cohort 3: 27.5 Gy Cohort 4: 30 Gy
Radiation: Stereotactic Radiation
Stereotactic Body Partial Breast irradiation Cohort 1: 22.5 Gy Cohort 2: 25 Gy Cohort 3: 27.5 Gy Cohort 4: 30 Gy
Other Name: SB-PBI

Primary Outcome Measures :
  1. maximum tolerated dose [ Time Frame: 3 years ]
    maximum tolerated radiation dose

Secondary Outcome Measures :
  1. dose-limiting toxicity [ Time Frame: 90 days ]
    dose-limiting toxicity for each dose level

  2. cosmesis [ Time Frame: follow up at month 3, 6, 12, 24, 36, 48, and 60 ]
    as evaluated by an independent panel judging from serial photography

Other Outcome Measures:
  1. breast recurrence rate [ Time Frame: 5 years ]
  2. distant disease-free interval [ Time Frame: 5 years ]
    the time from registration to first diagnosis of distant disease

  3. recurrence free survival [ Time Frame: 5 years ]
    time from registration to first diagnosis of a local, regional, or distant recurrence

  4. overall survival [ Time Frame: 5 years ]
    time from registration to death due to any cause

  5. treatment related fibrosis [ Time Frame: follow up at month 6, 12, 18, and 24 ]
    Strain elastography, an imaging modality, which will be utilized to determine different degrees of treatment related fibrosis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ductal carcinoma in situ (DCIS) or invasive epithelial (ductal, medullary, papillary, mucinous (colloid), or tubular histologies
  • Willing and able to provide consent
  • Age >=18 years.
  • Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
  • Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
  • Appropriate staging studies identifying as American Joint Committee on Cancer (AJCC) stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
  • Surgical treatment of the breast with lumpectomy Clinical Target Volume (CTV) margin up to 5 cm in maximum dimension with histologically confirmed margins free of tumor (negative margins defined as no tumor on ink in all directions). Re-excision of surgical margins is permitted.
  • Gross disease within the breast must be unifocal. (Patients with microscopic multifocality are eligible as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension 3 cm or less)
  • Patients with invasive disease are required to have axillary staging including: sentinel node biopsy alone if sentinel node is negative, sentinel node biopsy followed by axillary dissection with a minimum of 6 axillary nodes sampled if sentinel node is positive, or axillary dissection alone (with a minimum of 6 axillary nodes). Patients with DCIS are not required to have axillary staging.
  • Patients with a history of non-breast invasive malignancies are eligible if they have been disease-free for 3 or more years prior to entry into the study

Exclusion Criteria:

  • T2 (>3.0 cm), T3, stage III, or stage IV breast cancer
  • More than 3 histologically positive axillary lymph nodes or axillary lymph nodes with microscopic or macroscopic extracapsular extension.
  • Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor.
  • Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign.
  • Non epithelial breast malignancies such as sarcoma or lymphoma.
  • Multicentric gross breast carcinoma (either DCIS or invasive cancer) or microscopic breast carcinoma occupying a volume with maximum dimensions of more than 3 centimeters.
  • Synchronous bilateral invasive or non-invasive breast cancer.
  • Paget's disease of the nipple.
  • Previous breast radiation on ipsilateral side or thoracic radiation on the ipsilateral side.
  • Treatment plan that includes regional nodal irradiation.
  • Any prior treatment with radiation therapy or chemotherapy for the currently diagnosed breast cancer prior to registration. Endocrine therapy may be given but not within 28 days prior to study entry and must be stopped if the patient will be receiving chemotherapy until completion of chemotherapy. Patients must discontinue any hormonal agents such as raloxifene, tamoxifen, or other selective estrogen receptor modulators prior to registration.
  • Patients with collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or active skin rash, systemic lupus erythematosis, or scleroderma.
  • Pregnancy or lactation at the time of registration. For women of childbearing age, they must agree to use effective contraceptive methods such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills.
  • Patients with severe co-extensive comorbidities or significant psychiatric illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02685332

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United States, New York
NYU Winthrop Hospital
Mineola, New York, United States, 11501
United States, Texas
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
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Principal Investigator: Asal Rahimi, MD UTSW Medical Center
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Responsible Party: Asal Rahimi, ASSOC PROFESSOR, University of Texas Southwestern Medical Center Identifier: NCT02685332    
Other Study ID Numbers: STU 062015-085
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases