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

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ClinicalTrials.gov Identifier: NCT03137693
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Cancer Female Breast Adenocarcinoma Other: Standard of Care Schedule Variation: SABR Procedure: Breast-conserving Surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 28, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT03137693


Contacts
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Contact: Mia Aoki 813-745-4377 mia.aoki@moffitt.org
Contact: Michael Montejo, M.D. 813-745-7030 michael.montejo@moffitt.org

Locations
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United States, Florida
H. Lee Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Principal Investigator: Michael Montejo, M.D.         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
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Principal Investigator: Michael Montejo H. Lee Moffitt Cancer Center and Research Institute

Additional Information:
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT03137693     History of Changes
Other Study ID Numbers: MCC-18596
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
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

Additional relevant MeSH terms:
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Breast Neoplasms
Adenocarcinoma
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type