Breast CancerNCT05037019
SIGNAL During a COVID-19 Pandemic
A study testing Radiation therapy in people with Breast Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
The standard treatment for early stage, estrogen-receptor positive breast cancer is lumpectomy and sentinel lymph node biopsy followed by 16-25 treatments of adjuvant whole-breast radiation therapy plus or minus hormone therapy. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Female sex
- Age ≥ 50 years old
- Postmenopausal
- Tumor size < 3cm on pre-treatment imaging
- Any grade of disease, estrogen receptor (ER) positive, HER2 negative
- Unicentric/unifocal disease
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- Invasive ductal carcinoma or other favorable subtypes of epithelial breast malignancy (lobular, medullary, papillary, colloid, mucinous, or tubular) .
- Clinically node-negative (based upon pre-treatment physical examination and/or axillary ultrasound).
- Surgical expectation that a > 2mm margin can be obtained.
- Lesion is 1 cm or greater from the skin surface.
- Able to lie comfortably in the prone position with arms raised above the head for extended periods of time.
Who cannot join
- Male sex
- Under 50 years of age
- Previous RT to the same breast
- HER2 positive disease
- Evidence of suspicious diffuse microcalcifications in the breast prior to the start of radiation.
- Local metastatic spread into ipsilateral axilla and/or supraclavicular region and/or neck nodes and/or internal mammary nodes diagnosed on clinical examination or any imaging assessment (unless such sites can be confirmed as negative following biopsy)
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- Distant metastases
- Involvement of contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes (unless there is histologic confirmation that these nodes are negative)
- Prior non-hormonal therapy or radiation therapy for the current breast cancer
- Patients with Paget's disease of the nipple.
- Skin involvement, regardless of tumor size.
- Patients with a breast technically unsatisfactory for radiation therapy.
- Inability to lie prone with arms raised above head for extended periods of time.
- Patients not appropriate for BCS due to expectation of poor cosmetic result, even without RT
- Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis)
- Inability or unwillingness to provide informed consent.
- Any other malignancy at any site (except non-melanomatous skin cancer) < 5 years prior to study enrollment
- Patients who are pregnant or lactating
About this study
Official title: Single Fraction Preoperative Radiation as a Strategy for Local Control of Breast Cancer During a COVID-19 Pandemic
The standard treatment for early stage, estrogen-receptor positive breast cancer is lumpectomy and sentinel lymph node biopsy followed by 16-25 treatments of adjuvant whole-breast radiation therapy plus or minus hormone therapy. However, the COVID-19 pandemic has necessitated changes in the way breast cancer is treated in order to reduce contact between individuals, reduce spread of the novel coronavirus, and lessen the impact on health care resources. As elective surgeries are being cancelled, current pandemic guidelines recommend that patients be started on hormone treatment while waiting for surgeries to be re-instated. Only after this surgery occurs will patients receive radiation treatment, dramatically extending the time between diagnosis and end of treatment. Emergency pandemic guidelines in the UK and other countries recommend 5 fractions of pre-operative radiation therapy where appropriate. Based on previous work in the SIGNAL 1.0 and SIGNAL 2.0 clinical trials, the investigators are proposing treating patients with early stage breast cancers with one single fraction of stereotactic neoadjuvant radiation during the pre-operative waiting period. This will allow patients to complete radiation therapy upfront while reducing the number of patient visits to hospital. This will also allow investigators to evaluate the ability of single-fraction targeted radiation to induce a pathologic complete response.
- Conditions
- Breast Cancer
- Being tested
- Radiation therapy
- Keywords
- radiation therapy, radiotherapy, breast cancer, SBRT, neoadjuvant radiation, hypofractionation, stereotactic, preoperative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapyProcedure or surgery
Also called Radiotherapy, Stereotactic body radiation therapy (SBRT)
Women diagnosed with early stage breast cancer are given a single dose of stereotactic body radiation therapy (SBRT) prior to any other treatment in the context of delayed lumpectomy due to the COVID-19 pandemic.
| Study group | Role | What they receive |
|---|---|---|
| Single fraction radiotherapy | Experimental | Single fraction of 21 Gy stereotactic radiation therapy delivered to a single malignant lesion of the breast prior to any other treatment for breast cancer. Receives: Procedure: Radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic complete response (pCR)
To evaluate whether a pathologic complete response can be achieved when radiotherapy is delivered in a single 21 Gy fraction, establishing whether tumour response has a linear function with time in the context of delayed surgery. Pathologic complete response will be treated as a dichotomous variable (yes/no). Results will be stratified based on whether patients were also placed on neoadjuvant hormone treatment.
Measured: 1 year
Feasibility of SBRT during a pandemic
To demonstrate feasibility of treating early stage breast cancer patients with a single 21 Gy fraction during the COVID-19 pandemic. This will be measured by accrual rate and the number of patients that can be treated during this pandemic.
Measured: 1 year
Secondary outcomes (2)
Radiation toxicity
A secondary objective is to evaluate toxicity resulting from delivering radiation therapy in this manner. Toxicity will be evaluated using the CTCAE grading system.
Measured: 1.5 years
Cosmesis
A secondary objective is to evaluate breast cosmesis resulting from delivery of radiation therapy in this manner. Cosmesis will be evaluated using the Modified Harvard-Harris Scale.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study startMay 2020 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2022 (estimated)
Why it stopped: Surgery wait times during the COVID-19 pandemic were eventually reduced to pre-pandemic wait times. This study became irrelevant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muriel Brackstone, MD, PhD, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05037019
- Sponsor's protocol ID
- 115858
- Status last verified
- Sep 2021
- First submitted
- 5 May 2020
- Last updated
- 16 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Fraction Preoperative Radiation as a Strategy for Local Control of Breast Cancer During a COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT05037019
- Acronym / sponsor ID
- 115858
- Conditions
- Breast Cancer
- Keywords
- radiation therapy, radiotherapy, breast cancer, SBRT, neoadjuvant radiation, hypofractionation, stereotactic, preoperative
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Surgery wait times during the COVID-19 pandemic were eventually reduced to pre-pandemic wait times. This study became irrelevant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- May 2020 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2022 (estimated)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The standard treatment for early stage, estrogen-receptor positive breast cancer is lumpectomy and sentinel lymph node biopsy followed by 16-25 treatments of adjuvant whole-breast radiation therapy plus or minus hormone therapy. However, the COVID-19 pandemic has necessitated changes in the way breast cancer is treated in order to reduce contact between individuals, reduce spread of the novel coronavirus, and lessen the impact on health care resources. As elective surgeries are being cancelled, current pandemic guidelines recommend that patients be started on hormone treatment while waiting for surgeries to be re-instated. Only after this surgery occurs will patients receive radiation treatment, dramatically extending the time between diagnosis and end of treatment. Emergency pandemic guidelines in the UK and other countries recommend 5 fractions of pre-operative radiation therapy where appropriate. Based on previous work in the SIGNAL 1.0 and SIGNAL 2.0 clinical trials, the investigators are proposing treating patients with early stage breast cancers with one single fraction of stereotactic neoadjuvant radiation during the pre-operative waiting period. This will allow patients to complete radiation therapy upfront while reducing the number of patient visits to hospital. This will also allow investigators to evaluate the ability of single-fraction targeted radiation to induce a pathologic complete response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single fraction radiotherapy | Experimental | Procedure: Radiation therapySingle fraction of 21 Gy stereotactic radiation therapy delivered to a single malignant lesion of the breast prior to any other treatment for breast cancer. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Female sex
- Age ≥ 50 years old
- Postmenopausal
- Tumor size < 3cm on pre-treatment imaging
- Any grade of disease, estrogen receptor (ER) positive, HER2 negative
Key exclusion criteria (18 listed)
- Male sex
- Under 50 years of age
- Previous RT to the same breast
- HER2 positive disease
- Evidence of suspicious diffuse microcalcifications in the breast prior to the start of radiation.
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 |
|---|---|---|
| Radiation therapyAlso: Radiotherapy, Stereotactic body radiation therapy (SBRT)Women diagnosed with early stage breast cancer are given a single dose of stereotactic body radiation therapy (SBRT) prior to any other treatment in the context of delayed lumpectomy due to the COVID-19 pandemic. | Procedure or surgery | Single fraction radiotherapy |
Primary outcome
Pathologic complete response (pCR)
Time frame: 1 year
To evaluate whether a pathologic complete response can be achieved when radiotherapy is delivered in a single 21 Gy fraction, establishing whether tumour response has a linear function with time in the context of delayed surgery. Pathologic complete response will be treated as a dichotomous variable (yes/no). Results will be stratified based on whether patients were also placed on neoadjuvant hormone treatment.
Feasibility of SBRT during a pandemic
Time frame: 1 year
To demonstrate feasibility of treating early stage breast cancer patients with a single 21 Gy fraction during the COVID-19 pandemic. This will be measured by accrual rate and the number of patients that can be treated during this pandemic.
2 secondary outcomes
Radiation toxicity
Time frame: 1.5 years
Cosmesis
Time frame: 1.5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2022.
- 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.
Muriel Brackstone, MD, PhD principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Questions about this trial
What is this clinical trial studying?
A study testing Radiation therapy in people with Breast Cancer, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 18 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: withdrawn, as of the sponsor's last update on 16 May 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Pathologic complete response (pCR) (time frame: 1 year). The study lists 2 primary outcomes in all. 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 16 May 2022.