Clinical Trials /

Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer

NCT03137693

Description:

This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR). The purpose of this study is to evaluate the effects, good and/or bad, of pre-operative SABR specifically focusing on its ability to reduce the chances that additional breast surgery will be needed, reducing the amount of breast/heart/lung tissue that is irradiated, and to study the tumor-tissue effects of SABR. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer
  • Official Title: A Phase II Study of Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer: Introduction of a Novel Form of Accelerated Partial Breast Radiotherapy

Clinical Trial IDs

  • ORG STUDY ID: MCC-18596
  • NCT ID: NCT03137693

Conditions

  • Breast Cancer
  • Breast Cancer Female
  • Breast Adenocarcinoma

Purpose

This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR). The purpose of this study is to evaluate the effects, good and/or bad, of pre-operative SABR specifically focusing on its ability to reduce the chances that additional breast surgery will be needed, reducing the amount of breast/heart/lung tissue that is irradiated, and to study the tumor-tissue effects of SABR. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.

Trial Arms

NameTypeDescriptionInterventions
Change in Procedure SchedulingOtherPre-Surgery SABR: Treatment with Stereotactic Ablative Body Radiation Therapy (SABR) followed by breast-conserving surgery. The usual treatment for patients with early-stage breast cancer who have breast-conserving treatment (BCT) is to receive radiotherapy AFTER surgery, targeting either the whole breast or part of the breast.

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Understand and voluntarily sign an informed consent document prior to conducting any
                 study related assessments or procedures.
    
              -  Histologically proven invasive adenocarcinoma of breast.
    
              -  Must have marker clip indicating location of target tumor in breast.
    
              -  Unifocal tumor less than or equal to 2 cm based on contrast-enhanced prone-breast MRI.
    
              -  Must be clinically and radiographically node negative (N0) to participate on this
                 protocol. Clinically suspicious regional nodes by imaging or physical exam require
                 biopsy evaluation to exclude disease involvement.
    
              -  Appropriate candidate for breast-conserving surgery based on multi-disciplinary
                 assessment.
    
              -  Females age ≥ 50 years.
    
              -  Able to tolerate prone body positioning during radiation therapy.
    
              -  No prior breast or thoracic radiotherapy.
    
              -  As defined on MRI, target lesion must be at least 10 mm distance from skin (defined as
                 volume encompassing first 3 mm from breast surface).
    
              -  Must be estrogen receptor (ER) and progesterone receptor (PR) positive.
    
              -  Must be negative for Her-2 amplification. (Either 1+ on semi-quantitative evaluation
                 of immunostain or negative by fluorescent in-situ hybridization).
    
              -  No implanted hardware or other material that would prohibit appropriate treatment
                 planning or treatment delivery in the investigator's opinion.
    
              -  No history of an invasive malignancy (other than this breast cancer, or non-metastatic
                 basal or squamous skin cancers) in the last 5 years.
    
              -  Must not have received nor be planned for neoadjuvant chemotherapy prior to SABR or
                 surgery.
    
              -  ECOG performance status less than 2.
    
              -  Females of childbearing potential must have a negative urine pregnancy test prior to
                 simulation and within seven days of SABR start.
    
            Exclusion Criteria:
    
              -  Have invasive lobular carcinoma.
    
              -  Have a Tumor > 2 cm as measured on prone contrast-enhanced breast MRI.
    
              -  Have presence of histologically proven lymph node disease.
    
              -  Are not a candidate for breast conserving surgery.
    
              -  Have had prior breast or thoracic radiotherapy.
    
              -  History of scleroderma or lupus erythematosus with either cutaneous manifestation or
                 requiring active treatment.
    
              -  An MRI defined target tumor that is within 10 mm of skin (defined as volume
                 encompassing first 3 mm from skin surface).
    
              -  Have amplification of Her-2 (Either 3+ by semi-quantitative immunostain or positive by
                 Fluorescent in-situ hybridization (FISH)).
    
              -  Have implanted hardware or other material that would prohibit appropriate treatment
                 planning or treatment delivery in the investigator's opinion.
    
              -  History of an invasive malignancy (other than this breast cancer, or non-metastatic
                 basal or squamous skin cancers) in the last 5 years.
    
              -  Have received or plan to receive neoadjuvant chemotherapy either before radiotherapy
                 or before surgery.
    
              -  A known carrier of BRCA1 or BRCA2 gene mutation.
    
              -  Pregnant or unwilling to undergo pregnancy screening.
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:50 Years
    Eligible Gender:Female
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Rate of Pathologic Complete Response (pCR)
    Time Frame:6 weeks post SABR
    Safety Issue:
    Description:Rate of pathologic complete response following pre-operative SABR for early-stage breast carcinoma. pCR: The absence of residual invasive disease in the breast and in the axillary lymph nodes at the completion of the neoadjuvant treatment.

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

    Trial Keywords

    • histologically proven
    • invasive adenocarcinoma of breast
    • node negative (N0)
    • breast-conserving surgery
    • negative for Her-2 amplification
    • estrogen receptor (ER) positive
    • progesterone receptor (PR) positive

    Last Updated

    October 4, 2017