Study of Stereotactic Radiotherapy for Breast Cancer

Phase 2TerminatedNCT03043794

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins4 enrolled

Overview

This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.

This is a single arm phase II study design, evaluating the pathologic response (primary endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to intact breast tumors in patients with hormone-receptor positive early stage breast cancer.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Stereotactic Body Radiation Therapy SBRTRADIATION

Stereotactic Body Radiation Therapy to the breast to 21 Gy

Eligibility

Sex: FEMALEMin age: 50 YearsMax age: 100 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female sex * Age \> or = to 50 years of age * Invasive ductal carcinoma * Clinically and radiographically T1 tumor * Clinically node negative * Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior) * Planning breast conserving surgery including sentinel node biopsy * ≥10% expression of ER and/or PR * HER2- using the current College of American Pathologists guidelines * Post-menopausal * Willing and able to provide informed consent Exclusion Criteria: * Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma * Pure DCIS without invasive cancer * Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents * Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment * Positive pregnancy test * Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement. * Unable to meet dosimetric constraints due to tumor location and/or patient anatomy * Planning mastectomy * Unable to tolerate prone positioning

Locations (2)

Sibley Memorial Hospital

Washington D.C., District of Columbia, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Treatment Response Measured by Residual Cancer Burden (RCB)

Number of participants with Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)), and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors.

Time frame: 4-6 weeks

Secondary Outcomes

Number of Participants With Treatment-related Toxicity

The number of participants with severe acute toxicity, defined as any CTCAE v4 grade 3 or higher toxicity noted from RT delivery up to 90 days after completion of surgery, up to 4 months.

Time frame: RT delivery up to 90 days after completion of surgery, up to 4 months

Cosmetic Outcome (Patients)

Number of patients who report poor cosmetic outcomes from patient perspective at 90 days after pre-operative SBRT to intact breast tumors using the Radiation therapy oncology group (RTOG) cosmesis scale and digital images. RTOG Cosmesis Scale: 1 (excellent), 2 (good), 3 (fair), and 4 (poor)

Time frame: 90 days

Local Recurrence

To measure local recurrence in participants

Time frame: 1 year

Breast Cancer Treatment Outcomes Scale (BCTOS)

To assess patient reported satisfaction and quality of life with treatment using the Breast Cancer Treatment Outcomes Scale (BCTOS). The BCTOS is a questionnaire that evaluates the aesthetic and functional outcomes of breast conserving surgery (BCS). Patients rate each item on the questionnaire using a four-point Likert scale, with 1 indicating no difference and 4 indicating a large difference between the treated and untreated breast. Score range 22-88. Higher scores indicate higher difference.

Time frame: Pre and Post surgery (Up to 3 years)

Data from ClinicalTrials.gov

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