Clinical trial NCT02065960: Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer
Official title: Feasibility Study of the Role of Stereotactic Body Radiotherapy for the Treatment of Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Neoplasm
Keywords: Feasibility study
Early breast cancer
Stereotactic body radiotherapy
Cyberknife
Pre-operative radiotherapy
Lead sponsor: Juravinski Cancer Center
Sponsor class: OTHER
Collaborators: name: Juravinski Cancer Centre Foundation
name: Canadian Breast Cancer Foundation
First posted: 2014-02-19
Enrollment: 32
Sex: FEMALE
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Feasibility
timeFrame: At time of radiation treatment delivery
Secondary outcomes:
measure: Acute Radiation Toxicity
timeFrame: Within 3 months from radiation
measure: Late Radiation Toxicity
timeFrame: 3 months or more after radiation
measure: Pathological Response
timeFrame: At time of surgery (10-12 weeks post-radiation)
measure: Ipsilateral Breast Tumour Recurrence
timeFrame: At 5 years post-registration
measure: Disease Free Survival
timeFrame: At 5 years post-registration
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
Study officials:
affiliation: Juravinski Cancer Centre
name: Julie Arsenault, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Juravinski Cancer Centre
name: Do-Hoon Kim, BASc, MD, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Juravinski Cancer Centre
name: Timothy Whelan, BSc, BM,BCh, MSc, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: