Breast NeoplasmPhase 1ARTEMISNCT02065960
Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer
A Phase 1 study testing Stereotactic body radiotherapy (SBRT) in people with Breast Neoplasm, run by Juravinski Cancer Center at 1 site in Canada.
Trial summary
Most women with early breast cancer are treated with breast conserving therapy (BCT), consisting of breast conserving surgery (surgery to remove the cancer itself) followed by radiation to the breast. This treatment can take time and is associated with its own side effect profile. Read more about this study
- Who is it for?
- Ages 70 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- Stereotactic body radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Jun 2020
- Phase
- Phase 1
- 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 70 years and older
- Women only
- No healthy volunteers
- Older adult
Who may be able to join
- Women age ≥ 70 years;
- New histological diagnosis of invasive carcinoma of the breast, grade I or II, estrogen and progesterone receptor (ER and PR) positive, HER2 negative on needle biopsy and limited to Stage I (T1 N0 M0) on clinical and radiological assessment with MRI of the breasts and axillary ultrasound;
- Candidate for breast conserving surgery;
- Signed study consent form completed prior to study entry.
Who cannot join
- Breast cancer with disease within 5 mm from skin or chest wall;
- Previous or concomitant invasive malignancies treated within 5 years of study entry;
- Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus or scleroderma), which would preclude to definitive radiation therapy;
- Psychiatric disorders, which would preclude from obtaining informed consent
- Geographic inaccessibility for follow-up
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Juravinski Cancer Centre
Hamilton, Ontario, L8V 5C2
About this study
Official title: Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Cancer
Most women with early breast cancer are treated with breast conserving therapy (BCT), consisting of breast conserving surgery (surgery to remove the cancer itself) followed by radiation to the breast. This treatment can take time and is associated with its own side effect profile. An innovative radiation technique called stereotactic body radiotherapy (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been successfully used for a number of cancers and it is proposed that it could be used to eradicate breast cancer. This feasibility study will investigate the feasibility and safety of treatment using SBRT in women with early stage breast cancer.
Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5 treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast conserving surgery will be performed at 8-12 weeks after radiation to assess response to treatment. The primary outcome of the study will be feasibility, meaning the ability to deliver radiation treatment as planned. Secondary outcomes will include treatment related toxicity and pathological response.
If this study shows that SBRT can be used to treat patients primarily, it will lead to further evaluation of SBRT for early breast cancer.
- Conditions
- Breast Neoplasm
- Being tested
- Stereotactic body radiotherapy (SBRT)
- Keywords
- Feasibility study, Early breast cancer, Stereotactic body radiotherapy, Cyberknife, Pre-operative radiotherapy
- 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 radiotherapy (SBRT)Radiation
Also called Cyberknife
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiotherapy (SBRT) | Experimental | Radiotherapy with SBRT to a dose of 40 Gy in 5 fractions delivered every other day over a period of 10-12 days, followed by breast conserving surgery. Receives: Radiation: Stereotactic body radiotherapy (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
The primary outcome for this study will be successful delivery of SBRT as per protocol without a major deviation.
Measured: At time of radiation treatment delivery
Secondary outcomes (5)
Acute Radiation Toxicity
Measured: Within 3 months from radiation
Late Radiation Toxicity
Measured: 3 months or more after radiation
Pathological Response
Measured: At time of surgery (10-12 weeks post-radiation)
Ipsilateral Breast Tumour Recurrence
Measured: At 5 years post-registration
Disease Free Survival
Measured: At 5 years post-registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2016 (estimated)
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juravinski Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Juravinski Cancer Centre Foundation, Canadian Breast Cancer Foundation
- Responsible party
- Principal investigator, Julie Arsenault, Juravinski Cancer Center
- Investigators
- Julie Arsenault, MD, FRCPC, Principal investigator, Juravinski Cancer CentreDo-Hoon Kim, BASc, MD, MSc, FRCPC, Principal investigator, Juravinski Cancer CentreTimothy Whelan, BSc, BM,BCh, MSc, FRCPC, Principal investigator, Juravinski Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065960
- Sponsor's protocol ID
- 13-699
- Acronym
- ARTEMIS
- Status last verified
- Mar 2015
- First submitted
- 12 Feb 2014
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT02065960
- Acronym / sponsor ID
- ARTEMIS / 13-699
- Conditions
- Breast Neoplasm
- Keywords
- Feasibility study, Early breast cancer, Stereotactic body radiotherapy, Cyberknife, Pre-operative radiotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Juravinski Cancer CenterUniversity, hospital or other
- Collaborators
- Juravinski Cancer Centre Foundation, Canadian Breast Cancer Foundation
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2020 (estimated)
- First posted
- 19 Feb 2014 (estimated)
- 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.
Most women with early breast cancer are treated with breast conserving therapy (BCT), consisting of breast conserving surgery (surgery to remove the cancer itself) followed by radiation to the breast. This treatment can take time and is associated with its own side effect profile. An innovative radiation technique called stereotactic body radiotherapy (SBRT) can deliver large doses of radiation precisely to the tumour while avoiding critical organs, therefore destroying the cancer and avoiding surgery altogether. SBRT has been successfully used for a number of cancers and it is proposed that it could be used to eradicate breast cancer. This feasibility study will investigate the feasibility and safety of treatment using SBRT in women with early stage breast cancer.
Thirty-two women age 70 years or older with early breast cancer will be treated with SBRT (5 treatments) followed by breast conserving surgery and hormonal therapy. An MRI and breast conserving surgery will be performed at 8-12 weeks after radiation to assess response to treatment. The primary outcome of the study will be feasibility, meaning the ability to deliver radiation treatment as planned. Secondary outcomes will include treatment related toxicity and pathological response.
If this study shows that SBRT can be used to treat patients primarily, it will lead to further evaluation of SBRT for early breast cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiotherapy (SBRT) | Experimental | Radiation: Stereotactic body radiotherapy (SBRT)Radiotherapy with SBRT to a dose of 40 Gy in 5 fractions delivered every other day over a period of 10-12 days, followed by breast conserving surgery. |
Who may qualify
- Ages
- 70 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Women age ≥ 70 years;
- New histological diagnosis of invasive carcinoma of the breast, grade I or II, estrogen and progesterone receptor (ER and PR) positive, HER2 negative on needle biopsy and limited to Stage I (T1 N0 M0) on clinical and radiological assessment with MRI of the breasts and axillary ultrasound;
- Candidate for breast conserving surgery;
- Signed study consent form completed prior to study entry.
Key exclusion criteria (5 listed)
- Breast cancer with disease within 5 mm from skin or chest wall;
- Previous or concomitant invasive malignancies treated within 5 years of study entry;
- Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus or scleroderma), which would preclude to definitive radiation therapy;
- Psychiatric disorders, which would preclude from obtaining informed consent
- Geographic inaccessibility for follow-up
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 radiotherapy (SBRT)Also: Cyberknife | Radiation | Stereotactic body radiotherapy (SBRT) |
Primary outcome
Feasibility
Time frame: At time of radiation treatment delivery
The primary outcome for this study will be successful delivery of SBRT as per protocol without a major deviation.
5 secondary outcomes
Acute Radiation Toxicity
Time frame: Within 3 months from radiation
Late Radiation Toxicity
Time frame: 3 months or more after radiation
Pathological Response
Time frame: At time of surgery (10-12 weeks post-radiation)
Ipsilateral Breast Tumour Recurrence
Time frame: At 5 years post-registration
Disease Free Survival
Time frame: At 5 years post-registration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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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.
Julie Arsenault, MD, FRCPC principal investigator
Juravinski Cancer Centre
Do-Hoon Kim, BASc, MD, MSc, FRCPC principal investigator
Juravinski Cancer Centre
Timothy Whelan, BSc, BM,BCh, MSc, FRCPC principal investigator
Juravinski Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Stereotactic body radiotherapy (SBRT) in people with Breast Neoplasm, run by Juravinski Cancer Center at 1 site in Canada.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 31 Mar 2015. 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shelley Chambers, MA (905-387-9711 ext. 64510, shelley.chambers@jcc.hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: At time of radiation treatment delivery). 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 31 Mar 2015.