Recruiting
Phase 1

Stereotactic Body Radiotherapy

Sponsor:

Juravinski Cancer Center

Code:

NCT02065960

Conditions

Breast Neoplasm

Eligibility Criteria

Sex: Female

Age: 70+

Healthy Volunteers: Not accepted

Interventions

Stereotactic body radiotherapy (SBRT)

Study Details

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.

Conditions

Breast Neoplasm

Study ID

NCT02065960

Start date

Feb, 2014

Status verified date

Mar, 2015

Completion date

Jun, 2020

Anticipated

Primary completion date

Jun, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

32 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Stereotactic body radiotherapy (SBRT)

Primary outcome measure

  • Feasibility [ Time Frame: At time of radiation treatment delivery ]

Central Contacts and Locations

Central contacts

Shelley Chambers, MA

905-387-9711shelley.chambers@jcc.hhsc.ca

Julie Arsenault, MD, FRCPC

905-387-9495julie.arsenault@jcc.hhsc.ca

Locations

Juravinski Cancer Centre

Recruiting

Hamilton, Ontario, Canada, L8V 5C2

More Information

Sponsor

Juravinski Cancer Center

Last update posted

Mar 31, 2015

Last verified

Mar, 2015

Keywords

  • Feasibility study
  • Early breast cancer
  • Stereotactic body radiotherapy
  • Cyberknife
  • Pre-operative radiotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Juravinski Cancer Center on 2015-03-31.