Breast CancerPhase 2NCT03043794
Study of Stereotactic Radiotherapy for Breast Cancer
A Phase 2 study testing Stereotactic Body Radiation Therapy SBRT in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial summary
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer. Read more about this study
- Who is it for?
- Ages 50 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Stereotactic Body Radiation Therapy SBRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2017to 22 Oct 2023
- Phase
- Phase 2
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female sex
- Age > or = to 50 years of age
- Invasive ductal carcinoma
- Clinically and radiographically T1 tumor
- Clinically node negative
- Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior)
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- Planning breast conserving surgery including sentinel node biopsy
- ≥10% expression of ER and/or PR
- HER2- using the current College of American Pathologists guidelines
- Post-menopausal
- Willing and able to provide informed consent
Who cannot join
- Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma
- Pure DCIS without invasive cancer
- Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents
- Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment
- Positive pregnancy test
- Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
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- Unable to meet dosimetric constraints due to tumor location and/or patient anatomy
- Planning mastectomy
- Unable to tolerate prone positioning
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21231
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
About this study
Official title: A Phase II Study of Preoperative Single Fraction Stereotactic Body Radiotherapy to the Intact Breast in Early Stage Low Risk Breast Cancer: Analysis of Radiation Response
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
Read the detailed description
This is a single arm phase II study design, evaluating the pathologic response (primary endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to intact breast tumors in patients with hormone-receptor positive early stage breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Stereotactic Body Radiation Therapy SBRT
- Keywords
- early stage, low risk
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic Body Radiation Therapy SBRTRadiation
Stereotactic Body Radiation Therapy to the breast to 21 Gy
| Study group | Role | What they receive |
|---|---|---|
| SBRT to the breast then surgery | Experimental | Stereotactic Body Radiation Therapy (SBRT) of 21Gy followed by standard of care surgery Receives: Radiation: Stereotactic Body Radiation Therapy SBRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Response Measured by Residual Cancer Burden (RCB)
Number of participants with Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)), and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors.
Measured: 4-6 weeks
Secondary outcomes (5)
Number of Participants With Treatment-related Toxicity
The number of participants with severe acute toxicity, defined as any CTCAE v4 grade 3 or higher toxicity noted from RT delivery up to 90 days after completion of surgery, up to 4 months.
Measured: RT delivery up to 90 days after completion of surgery, up to 4 months
Cosmetic Outcome (Patients)
Number of patients who report poor cosmetic outcomes from patient perspective at 90 days after pre-operative SBRT to intact breast tumors using the Radiation therapy oncology group (RTOG) cosmesis scale and digital images.
RTOG Cosmesis Scale: 1 (excellent), 2 (good), 3 (fair), and 4 (poor)
Measured: 90 days
Local Recurrence
To measure local recurrence in participants
Measured: 1 year
Breast Cancer Treatment Outcomes Scale (BCTOS)
To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS). The BCTOS is a questionnaire that evaluates the aesthetic and functional outcomes of breast conserving surgery (BCS). Patients rate each item on the questionnaire using a four-point Likert scale, with 1 indicating no difference and 4 indicating a large difference between the treated and untreated breast. Score range 22-88. Higher scores indicate higher difference.
Measured: Pre and Post surgery (Up to 3 years)
Cosmetic Outcome (Provider)
Number of providers who report poor cosmetic outcomes from provider perspective at 90 days after pre-operative SBRT to intact breast tumors using the RTOG (Radiation therapy oncology group) cosmesis scale and digital images.
RTOG Cosmesis Scale: 1 (excellent), 2 (good), 3 (fair), and 4 (poor)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2017 (estimated)
- Study start1 Aug 2017
- Primary completion20 Oct 2021
- Study completion22 Oct 2023
Why it stopped: PI closed. Unable to enroll enough patients to collect and analyze data.
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.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- SBRT to the breast follow by standard of care surgery
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Robert L. Sloan Fund for Cancer Research
- Responsible party
- Sponsor
- Investigators
- Jean Wright, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03043794
- Sponsor's protocol ID
- J1741
- Other IDs
- IRB00128074
- Status last verified
- Aug 2024
- First submitted
- 2 Feb 2017
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Preoperative Single Fraction Stereotactic Body Radiotherapy to the Intact Breast in Early Stage Low Risk Breast Cancer: Analysis of Radiation Response
- ClinicalTrials.gov ID
- NCT03043794
- Acronym / sponsor ID
- J1741
- Conditions
- Breast Cancer
- Keywords
- early stage, low risk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI closed. Unable to enroll enough patients to collect and analyze data.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Robert L. Sloan Fund for Cancer Research
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 22 Oct 2023 (actual)
- First posted
- 6 Feb 2017 (estimated)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
Detailed description
This is a single arm phase II study design, evaluating the pathologic response (primary endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to intact breast tumors in patients with hormone-receptor positive early stage breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- SBRT to the breast follow by standard of care surgery
| Arm | Type | Receives |
|---|---|---|
| SBRT to the breast then surgery | Experimental | Radiation: Stereotactic Body Radiation Therapy SBRTStereotactic Body Radiation Therapy (SBRT) of 21Gy followed by standard of care surgery |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female sex
- Age > or = to 50 years of age
- Invasive ductal carcinoma
- Clinically and radiographically T1 tumor
- Clinically node negative
Key exclusion criteria (9 listed)
- Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma
- Pure DCIS without invasive cancer
- Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents
- Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment
- Positive pregnancy test
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 |
|---|---|---|
| Stereotactic Body Radiation Therapy SBRTStereotactic Body Radiation Therapy to the breast to 21 Gy | Radiation | SBRT to the breast then surgery |
Primary outcome
Treatment Response Measured by Residual Cancer Burden (RCB)
Time frame: 4-6 weeks
Number of participants with Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)), and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors.
5 secondary outcomes
Number of Participants With Treatment-related Toxicity
Time frame: RT delivery up to 90 days after completion of surgery, up to 4 months
Cosmetic Outcome (Patients)
Time frame: 90 days
Local Recurrence
Time frame: 1 year
Breast Cancer Treatment Outcomes Scale (BCTOS)
Time frame: Pre and Post surgery (Up to 3 years)
Cosmetic Outcome (Provider)
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Jean Wright, MD principal investigator
Johns Hopkins University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Stereotactic Body Radiation Therapy SBRT in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites 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 11 inclusion and 9 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). 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?
Treatment Response Measured by Residual Cancer Burden (RCB) (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.