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

February 21, 2023 updated by: H. Lee Moffitt Cancer Center and Research Institute

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 ipsilateral-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) 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 ipsilateral-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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Change in Procedure Scheduling
Pre-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.
Other: Standard of Care Schedule Variation: SABR
SABR will be delivered over 3 days, prior to surgery.
Other Names:
  • radiotherapy
  • Stereotactic Ablative Body Radiation Therapy (SABR)
Procedure: Breast-conserving Surgery
Breast-conserving surgery will be scheduled for 6-8 weeks after SABR and will be conducted by a Moffitt breast surgeon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Pathologic Complete Response (pCR)
Time Frame: 6 weeks post SABR
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.
6 weeks post SABR

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Investigators

  • Principal Investigator: Michael Montejo, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 29, 2017

Primary Completion (Actual)

November 1, 2019

Study Completion (Actual)

January 27, 2020

Study Registration Dates

First Submitted

April 28, 2017

First Submitted That Met QC Criteria

April 28, 2017

First Posted (Actual)

May 3, 2017

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-18596

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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