Three Fraction Radiation to Induce Immuno-Oncologic Response

Plain-language summary

This study looks at whether three-fraction radiotherapy given before surgery (neoadjuvant) can trigger an immuno-oncologic response in patients with locally advanced breast cancer. It can enroll patients aged 18 and older with biopsy-proven Stage IIB-III breast cancer who are planned for neoadjuvant chemotherapy. It is a study without an assigned phase and is currently not recruiting but still ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Active, not recruiting

Sponsor

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

Intervention

Neoadjuvant radiotherapy

Start date

9/2/2020

Estimated completion

7/1/2026

Countries

Canada

Related genes

Locations

• London, Canada

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Any biopsy-proven locally advanced breast cancer patient defined as Stages IIB-III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2-positive breast cancers
2. Invasive mammary carcinoma of any subtype excluding lobular, sarcomatous, or metaplastic subtypes, or with lobular features
3. Plan to be treated with neoadjuvant chemotherapy
4. Able to fit in/have MRI
5. 18 years of age or older
6. Able to tolerate core needle biopsies
7. Able to provide informed consent
8. No evidence of metastatic disease

Exclusion Criteria:

1. Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery
2. Prior treatment for current breast cancer
3. Previous radiation therapy to the same breast
4. Inflammatory breast carcinoma
5. Invasive lobular carcinoma or invasive mammary carcinoma with lobular, sarcomatous, or metaplastic subtypes, or with lobular features
6. Recurrent breast cancer
7. Bilateral breast cancer
8. Evidence of distant metastatic disease
9. Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis, psoriatic arthritis)
10. Any other malignancy at any site (except non-melanomatous skin cancer) \<5 years prior to study enrollment
11. Inability to lay prone with arms above the head for extended periods of time
12. Inability to fit in/have an MRI
13. Inability to tolerate core needle biopsies
14. Pregnant or lactating
15. Under 18 years of age
16. Inability or unwillingness to provide informed consent