SIGNAL During a COVID-19 Pandemic

NCT05037019 | Withdrawn DMC

• 1 other identifier: 115858
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The standard treatment for early stage, estrogen-receptor positive breast cancer is lumpectomy and sentinel lymph node biopsy followed by 16-25 treatments of adjuvant whole-breast radiation therapy plus or minus hormone therapy. However, the COVID-19 pandemic has necessitated changes in the way breast cancer is treated in order to reduce contact between individuals, reduce spread of the novel coronavirus, and lessen the impact on health care resources. As elective surgeries are being cancelled, current pandemic guidelines recommend that patients be started on hormone treatment while waiting for surgeries to be re-instated. Only after this surgery occurs will patients receive radiation treatment, dramatically extending the time between diagnosis and end of treatment. Emergency pandemic guidelines in the UK and other countries recommend 5 fractions of pre-operative radiation therapy where appropriate. Based on previous work in the SIGNAL 1.0 and SIGNAL 2.0 clinical trials, the investigators are proposing treating patients with early stage breast cancers with one single fraction of stereotactic neoadjuvant radiation during the pre-operative waiting period. This will allow patients to complete radiation therapy upfront while reducing the number of patient visits to hospital. This will also allow investigators to evaluate the ability of single-fraction targeted radiation to induce a pathologic complete response.

Conditions

Breast Cancer

Keywords

radiation therapy; radiotherapy; breast cancer; SBRT; neoadjuvant radiation; hypofractionation; stereotactic; preoperative

Outcome Measures

Primary Outcomes (2)

• Pathologic complete response (pCR)

  To evaluate whether a pathologic complete response can be achieved when radiotherapy is delivered in a single 21 Gy fraction, establishing whether tumour response has a linear function with time in the context of delayed surgery. Pathologic complete response will be treated as a dichotomous variable (yes/no). Results will be stratified based on whether patients were also placed on neoadjuvant hormone treatment.

  1 year

• Feasibility of SBRT during a pandemic

  To demonstrate feasibility of treating early stage breast cancer patients with a single 21 Gy fraction during the COVID-19 pandemic. This will be measured by accrual rate and the number of patients that can be treated during this pandemic.

  1 year

Secondary Outcomes (2)

• Radiation toxicity

  1.5 years

• Cosmesis

  1.5 years

Study Arms (1)

Single fraction radiotherapy

EXPERIMENTAL

Single fraction of 21 Gy stereotactic radiation therapy delivered to a single malignant lesion of the breast prior to any other treatment for breast cancer.

Procedure: Radiation therapy

Interventions

Radiation therapy PROCEDURE

Women diagnosed with early stage breast cancer are given a single dose of stereotactic body radiation therapy (SBRT) prior to any other treatment in the context of delayed lumpectomy due to the COVID-19 pandemic.

Also known as: Radiotherapy, Stereotactic body radiation therapy (SBRT)

Single fraction radiotherapy

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female sex
• Age ≥ 50 years old
• Postmenopausal
• Tumor size \< 3cm on pre-treatment imaging
• Any grade of disease, estrogen receptor (ER) positive, HER2 negative
• Unicentric/unifocal disease
• Invasive ductal carcinoma or other favorable subtypes of epithelial breast malignancy (lobular, medullary, papillary, colloid, mucinous, or tubular) .
• Clinically node-negative (based upon pre-treatment physical examination and/or axillary ultrasound).
• Surgical expectation that a \> 2mm margin can be obtained.
• Lesion is 1 cm or greater from the skin surface.
• Able to lie comfortably in the prone position with arms raised above the head for extended periods of time.

You may not qualify if:

• Male sex
• Under 50 years of age
• Previous RT to the same breast
• HER2 positive disease
• Evidence of suspicious diffuse microcalcifications in the breast prior to the start of radiation.
• Local metastatic spread into ipsilateral axilla and/or supraclavicular region and/or neck nodes and/or internal mammary nodes diagnosed on clinical examination or any imaging assessment (unless such sites can be confirmed as negative following biopsy)
• Distant metastases
• Involvement of contralateral axillary, supraclavicular, infraclavicular or internal mammary nodes (unless there is histologic confirmation that these nodes are negative)
• Prior non-hormonal therapy or radiation therapy for the current breast cancer
• Patients with Paget's disease of the nipple.
• Skin involvement, regardless of tumor size.
• Patients with a breast technically unsatisfactory for radiation therapy.
• Inability to lie prone with arms raised above head for extended periods of time.
• Patients not appropriate for BCS due to expectation of poor cosmetic result, even without RT
• Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy; Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Muriel Brackstone, MD, PhD

  London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: September 8, 2021
• Study Start: May 1, 2020
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2022
• Last Updated: May 16, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share