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Early Stage Breast CarcinomaSIGNAL 2NCT02212860

Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy

A study testing Stereotactic Body Radiation Then Surgery in people with Early Stage Breast Carcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Radiation therapy after surgery to remove breast cancer improves control of the breast cancer. Standard therapy after breast conservation surgery is five to six weeks of radiation to the entire breast. Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Early Stage Breast Carcinoma
What is being tested?
Stereotactic Body Radiation Then Surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
1 siteCanada
Study dates
27 Apr 2015to Apr 2024
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

  • Age ≥ 50 years and postmenopausal
  • Tumor size < 3cm on pre-treatment imaging
  • Any grade of disease, estrogen receptor (ER) positive
  • Unicentric/unifocal disease
  • 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).
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  • Surgical expectation that a > 2mm margin can be obtained.
  • Lesion is 1 cm or greater from the skin surface.
  • Able to have surgery within 14-20 days of radiation therapy.
  • Able to lie comfortably in the prone position with arms raised above the head for extended periods of time.

Who cannot join

  • Previous RT to the same breast
  • 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)
  • 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
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  • 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 breast conserving surgery 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • London Regional Cancer Program of the Lawson Health Research Institute

    London, Ontario, N6A 4L6

Other trials in Canada

About this study

Official title: Clinical Trial to Evaluate Single Dose Versus Three Doses of Stereotactic Radiation Therapy (SBRT) Prior to Surgery for Early Stage Breast Carcinoma: SIGNAL 2.0 (Stereotactic Image-Guided Neoadjuvant Ablative Radiation Then Lumpectomy) Trial

Radiation therapy after surgery to remove breast cancer improves control of the breast cancer. Standard therapy after breast conservation surgery is five to six weeks of radiation to the entire breast.

This clinical trial will evaluate the effectiveness of conformal radiation therapy delivered only to the area in the breast where the lumpectomy will be performed.

Read more

This study will determine if radiation therapy delivered in this manner will prevent the cancer from coming back and eliminate the need for five to six weeks of radiation. Eligible participants will be randomized to one of two arms; Arm 1 which is comprised of one neoadjuvant radiation treatment, or Arm 2 which is comprised of three neoadjuvant radiation treatments.

The study will also gather information about the safety and effects (good and bad) this radiation has, the immune priming effects of this radiation, and on patient satisfaction with the appearance of the breast.

Read the detailed description

Our proposal represents the convergence of several recent developments in the treatment of patients with low-risk carcinoma of the breast. For the selected subset of patients with low-risk disease, it appears that intra-operative radiotherapy with a single fraction leads to acceptable clinical outcomes in terms of local control, overall survival and toxicity. There have also been a few Phase I dose escalation trials demonstrating safety with single fraction breast radiation.

In this study, we propose the delivery of radiotherapy using stereotactic body radiation therapy in two different regimens; a single 21 Gy fraction, or 3 10Gy fractions. Radiation will be delivered using Volumetric-modulated arc therapy (VMAT), planned on coregistered MRI (with a subset having a 3T PET-MRI) and CT imaging, and delivered prone. Our approach will potentially have numerous benefits, including significantly shortened treatment time, convenience and potentially reduced health care costs. It would significantly improve the quality of life of many patients.

This study will also provide a unique opportunity for pathologic assessment of the impact of radiation at a microscopic level and on tumour and immune markers without the confounding impact of systemic treatments, comparing pre- to post-radiation biopsy specimens for imaging and histologic predictors of radiation sensitivity.

Being tested
Stereotactic Body Radiation Then Surgery
Keywords
neoadjuvant, radiation, breast, cancer, hypofractionation, stereotactic, preoperative
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Stereotactic Body Radiation Then SurgeryRadiation

    Also called Neoadjuvant radiation

    Stereotactic image-guided neoadjuvant ablative radiation (randomized to single dose of 21 Gy or three 10 Gy doses) followed by lumpectomy for early stage breast carcinoma

Study groups in NCT02212860
Study groupRoleWhat they receive
Single FractionExperimentalStereotactic neoadjuvant ablative radiation give in one single dose of 21 Gy. Lumpectomy to follow within 14-20 from radiation treatment date.
Receives: Radiation: Stereotactic Body Radiation Then Surgery
Three FractionsExperimentalStereotactic neoadjuvant ablative radiation give in three doses of 10 Gy (30 Gy given in 3 fractions, one treatment every second business day). Lumpectomy to follow within 14-20 days from last radiation treatment.
Receives: Radiation: Stereotactic Body Radiation Then Surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immune priming will be measured

    Immune priming effects of both treatment arms will be evaluated by quantifying tumour infiltrating lymphocytes (CD8) into tumour specimen, as well as the expression of immune markers (PDL1, Fox3) and immune panel in blood (CD4, CD8, neutrophil, and macrophage counts).

    Measured: 1.5 years

  2. Angiogenesis will be measured

    Angiogenesis will be examined using the CD31 or VEGF-a cell markers

    Measured: 1.5 years

  3. Proliferation markers will be measured

    Proliferation will be examined using the Ki67 marker, hypoxia will be examined using the Carbonic Anhydrase 9 (CAH IX), or HIF1/HIF2 markers, apoptosis will be examined using the Caspase-3, or Tunnel markers, invasion will be analyzed using the vimentin, or SDF1-a markers.

    Measured: 1.5 years

  4. Hypoxia markers will be measured

    Hypoxia will be examined using the Carbonic Anhydrase 9 (CAH IX), or HIF1/HIF2 markers, apoptosis will be examined using the Caspase-3, or Tunnel markers, invasion will be analyzed using the vimentin, or SDF1-a markers.

    Measured: 1.5 years

  5. Apoptosis markers will be measured

    Apoptosis will be examined using the Caspase-3, or Tunnel markers, invasion will be analyzed using the vimentin, or SDF1-a markers.

    Measured: 1.5 years

  6. Invasion markers will be measured

    Invasion will be analyzed using the vimentin, or SDF1-a markers.

    Measured: 1.5 years

  7. Toxicity resulting from radiation treatment

    Toxicity resulting from radiation treatment will be collected and graded according to the Common Terminology Criteria for Adverse Events, version 4.0

    Measured: 1.5 years

Secondary outcomes (4)

  1. Cosmesis of the treated breast

    cosmetic result of treated breast as judged by the patient, surgeon, and radiation oncologist. Patients will self-assess cosmesis using the Modified Harvard-Harris Cosmetic Scale. The surgeon and radiation oncologist will assess cosmesis using photographs and the Modified Harvard-Harris Cosmetic Scale.

    Measured: 1.5 years

  2. Disease-Free Survival

    Disease recurrences will be recorded. Any tumor recurrence or death is considered a treatment failure.

    Measured: 8.5 years

  3. Mastectomy-Free Survival

    All surgical interventions will be recorded. Mastectomy and death will be considered treatment failures.

    Measured: 8.5 years

  4. Overall Survival

    Death from any cause is considered a treatment failure.

    Measured: 8.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2014 (estimated)
  2. Study start27 Apr 2015
  3. Primary completion23 Apr 2021
  4. Study completionApr 2024

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
139 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02212860
Sponsor's protocol ID
SIGNAL
Acronym
SIGNAL 2
Status last verified
Feb 2026
First submitted
5 Aug 2014
Last updated
11 Feb 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Stereotactic Body Radiation Then Surgery in people with Early Stage Breast Carcinoma, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 10 inclusion and 15 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: finished, as of the sponsor's last update on 11 Feb 2026. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Immune priming will be measured (time frame: 1.5 years). The study lists 7 primary outcomes in all. 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 NCT02212860.

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 11 Feb 2026.

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