Breast CancerNCT03137693
Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer
A study testing Breast-conserving Surgery in people with Breast Cancer and Breast Cancer Female, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female, Breast Adenocarcinoma
- What is being tested?
- Breast-conserving Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2017to 27 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 17Show fewer
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
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
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.
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Adenocarcinoma
- Being tested
- Standard of Care Schedule Variation: SABR, Breast-conserving Surgery
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Schedule Variation: SABROther
Also called radiotherapy, Stereotactic Ablative Body Radiation Therapy (SABR)
SABR will be delivered over 3 days, prior to surgery.
Breast-conserving SurgeryProcedure or surgery
Breast-conserving surgery will be scheduled for 6-8 weeks after SABR and will be conducted by a Moffitt breast surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Change in Procedure Scheduling | Other | 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. Receives: Other: Standard of Care Schedule Variation: SABR; Procedure: Breast-conserving Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 weeks post SABR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start29 Nov 2017
- Primary completion1 Nov 2019
- Study completion27 Jan 2020
Why it stopped: no responders/lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Montejo, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03137693
- Sponsor's protocol ID
- MCC-18596
- Status last verified
- Feb 2023
- First submitted
- 28 Apr 2017
- Last updated
- 23 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liveringhouse CL, Mills MN, Ahmed KA, Washington IR, Lee MC, Khakpour N, Laronga C, Czerniecki B, Soliman H, Weinfurtner RJ, Rosa M, Kim Y, Stringfield O, Abdalah M, Diaz R, Montejo M. Phase 2 Study of Preoperative SABR for Early-Stage Breast Cancer: Introduction of a Novel Form of Accelerated Partial Breast Radiation Therapy. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):611-616. doi: 10.1016/j.ijrobp.2022.12.036. Epub 2023 Feb 15. No abstract available.
PubMed 36796498Weinfurtner 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 at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03137693
- Acronym / sponsor ID
- MCC-18596
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no responders/lack of efficacy
- Enrolment
- 20 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 27 Jan 2020 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 28 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Change in Procedure Scheduling | Other | Other: Standard of Care Schedule Variation: SABR, Procedure: Breast-conserving SurgeryPre-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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care Schedule Variation: SABRAlso: radiotherapy, Stereotactic Ablative Body Radiation Therapy (SABR)SABR will be delivered over 3 days, prior to surgery. | Other | Change in Procedure Scheduling |
| Breast-conserving SurgeryBreast-conserving surgery will be scheduled for 6-8 weeks after SABR and will be conducted by a Moffitt breast surgeon. | Procedure or surgery | Change in Procedure Scheduling |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36796498Liveringhouse CL, Mills MN, Ahmed KA, Washington IR, Lee MC, Khakpour N, Laronga C, Czerniecki B, Soliman H, Weinfurtner RJ, Rosa M, Kim Y, Stringfield O, Abdalah M, Diaz R, Montejo M. Phase 2 Study of Preoperative SABR for Early-Stage Breast Cancer: Introduction of a Novel Form of Accelerated Partial Breast Radiation Therapy. Int J Radiat Oncol Biol Phys. 2023 Jul 1;116(3):611-616. doi: 10.1016/j.ijrobp.2022.12.036. Epub 2023 Feb 15. No abstract available.
- Derived from this study: PubMed 34384695Weinfurtner 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.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Montejo principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast-conserving Surgery in people with Breast Cancer and Breast Cancer Female, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Pathologic Complete Response (pCR) (time frame: 6 weeks post SABR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03137693, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.