Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer

NCT ID: NCT02065960

Last Updated: 2015-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2020-06-30

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 Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Stereotactic body radiotherapy (SBRT)

Intervention Type: RADIATION

Interventions

Stereotactic body radiotherapy (SBRT)

Intervention Type: RADIATION

Other Intervention Names

Cyberknife

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Juravinski Cancer Centre Foundation

OTHER

Sponsor Role: collaborator

Canadian Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

Juravinski Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Julie Arsenault

MD, FRCPC, Clinical Research Fellow, Radiation Oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Julie Arsenault, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Juravinski Cancer Centre

Do-Hoon Kim, BASc, MD, MSc, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Juravinski Cancer Centre

Timothy Whelan, BSc, BM,BCh, MSc, FRCPC

Role: PRINCIPAL_INVESTIGATOR

Juravinski Cancer Centre

Locations

Juravinski Cancer Centre

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Shelley Chambers, MA

Role: CONTACT

shelley.chambers@jcc.hhsc.ca

905-387-9711 ext. 64510

Julie Arsenault, MD, FRCPC

Role: CONTACT

julie.arsenault@jcc.hhsc.ca

905-387-9495

Other Identifiers

13-699

Identifier Type: -

Identifier Source: org_study_id