Feasibility Study of Stereotactic Body Radiotherapy for Early Breast Cancer

NCT02065960 | Unknown Phase 1 DMC

• 1 other identifier: 13-699
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Feasibility

  The primary outcome for this study will be successful delivery of SBRT as per protocol without a major deviation.

  At time of radiation treatment delivery

Secondary Outcomes (5)

• Acute Radiation Toxicity

  Within 3 months from radiation

• Late Radiation Toxicity

  3 months or more after radiation

• Pathological Response

  At time of surgery (10-12 weeks post-radiation)

• Ipsilateral Breast Tumour Recurrence

  At 5 years post-registration

• Disease Free Survival

  At 5 years post-registration

Study Arms (1)

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.

Radiation: Stereotactic body radiotherapy (SBRT)

Interventions

Stereotactic body radiotherapy (SBRT) RADIATION

Also known as: Cyberknife

Stereotactic body radiotherapy (SBRT)

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Juravinski Cancer Center: lead
• Juravinski Cancer Centre Foundation: collaborator
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Julie Arsenault, MD, FRCPC

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

• Do-Hoon Kim, BASc, MD, MSc, FRCPC

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

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

  Juravinski Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelley Chambers, MA

CONTACT

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

Julie Arsenault, MD, FRCPC

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, FRCPC, Clinical Research Fellow, Radiation Oncology

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 19, 2014
• Study Start: February 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2020
• Last Updated: March 31, 2015

Record last verified: 2015-03

Locations

CA (1)