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TerminatedNCT03137693Updated Feb 23, 2023Results posted

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

An interventional study of Standard of Care Schedule Variation: SABR and Breast-conserving Surgery in Breast Cancer, Breast Cancer Female and Breast Adenocarcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Terminated at 1 site in United States. Open to female participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-02-23.

Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Not applicable, Interventional, and Treatment

Why this study was terminated
no responders/lack of efficacy
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
50 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer
  • Breast Cancer Female
  • Breast Adenocarcinoma

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
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In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 20 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.

Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • 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 · Procedure: Breast-conserving Surgery

Interventions

  • OtherStandard of Care Schedule Variation: SABR

    SABR will be delivered over 3 days, prior to surgery.

    Also known as: radiotherapy, Stereotactic Ablative Body Radiation Therapy (SABR)

  • ProcedureBreast-conserving Surgery

    Breast-conserving surgery will be scheduled for 6-8 weeks after SABR and will be conducted by a Moffitt breast surgeon.

06

What researchers measure

Primary outcomes

  1. Rate of Pathologic Complete Response (pCR)

    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.

    Time frame: 6 weeks post SABR

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Results

Posted Dec 28, 2020

Participant flow

Participant flow — Overall Study
MilestoneAll Participants
Started20
Completed20
Not completed0

Outcome measures

PrimaryRate of Pathologic Complete Response (pCR)

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.

Time frame:
6 weeks post SABR
Reported as:
Number · percentage of participants
Rate of Pathologic Complete Response (pCR)
percentage of participantsAll Participants
Rate of Pathologic Complete Response (pCR)0

Adverse events

Collected over 1 year, 11 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
All Participants0/20 (0%)0/20 (0%)3/20 (15%)
Most frequent other events
Most frequent other events
EventAll Participants
PainGeneral disorders2/20
Dermatitis radiationInjury, poisoning and procedural complications1/20
Infections and Infestations - OtherInfections and infestations1/20

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)All Participants
<=18 years0
Between 18 and 65 years9
>=65 years11
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female20
Male0
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Participants
Hispanic or Latino3
Not Hispanic or Latino17
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Participants
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American0
White19
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)All Participants
United States20
08

Study locations

1 site
  • H. Lee Moffitt Cancer Center and Research Institute
    Tampa, Florida 33612, United States
09

References and documents

Publications

  • Weinfurtner RJ, Raghunand N, Stringfield O, Abdalah M, Niell BL, Ataya D, Williams A, Mooney B, Rosa M, Lee MC, Khakpour N, Laronga C, Czerniecki B, Diaz R, Ahmed K, Washington I, Montejo M. MRI Response to Pre-operative Stereotactic Ablative Body Radiotherapy (SABR) in Early Stage ER/PR+ HER2- Breast Cancer correlates with Surgical Pathology Tumor Bed Cellularity. Clin Breast Cancer. 2022 Feb;22(2):e214-e223. doi: 10.1016/j.clbc.2021.06.016. Epub 2021 Jul 20. PubMed 34384695 ↗

Study documents

  • Protocol and statistical analysis plan · Mar 30, 2020

Documents are hosted by the registry — open the source record to download them.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03137693
Lead sponsor
H. Lee Moffitt Cancer Center and Research Institute
Responsible party
Sponsor
First posted
May 3, 2017
Start date
Nov 29, 2017
Primary completion
Nov 1, 2019
Completion
Jan 27, 2020
Results posted
Dec 28, 2020
Last update
Feb 23, 2023

Study contacts

Michael Montejo
principal investigator · H. Lee Moffitt Cancer Center and Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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