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Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer

ConditionsBreast CancerBreast Cancer Stage IIBreast Cancer Stage IIIBreast Cancer InvasiveBreast Cancer Triple Negative
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

About this trial

This study will evaluate the immune-priming effects of stereotactic body radiation therapy (SBRT) regimen coupled with two injections of pembrolizumab in high-risk primary breast carcinoma prior to neoadjuvant chemotherapy. Preliminary results from the investigators' local TRIO Trial suggest that SBRT prior to neoadjuvant chemotherapy (NAC) may result in improved response rates due to the combined effect of radiation therapy (RT) and chemotherapy. The investigators aim to augment this effect with the addition of pembrolizumab, a monoclonal antibody that binds to and blocks programmed cell death protein 1 (PD-1).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Invasive ductal carcinoma of any subtype (including invasive mammary carcinoma with lobular features), excluding sarcomatous, signet or metaplastic subtypes.

Invasive mammary carcinoma of stages IIB - III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2+ breast cancers.

Lesion palpable by treating physician.

Plan to be treated with neoadjuvant chemotherapy.

Disqualifiers

Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery (e.g., uncontrolled diabetes, serious heart condition, etc).

Prior treatment for current breast cancer.

Previous radiation therapy to the same breast.

Inflammatory breast carcinoma.

Trial design

Design model

Single group

Treatments tested in this trial

  • Radiation

    Radiation

    Stereotactic body radiation therapy to the breast

  • Pembrolizumab (KEYTRUDA®)

    Drug

    Two injections

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: SBRT with PembrolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Pathological Complete Response

Pathologic complete response rates after neoadjuvant radiotherapy, pembrolizumab and chemotherapy will be evaluated.

Time frame
Measured at time of surgery, typically 6 months after enrollment in trial.

Secondary outcomes

1

Immune priming

To evaluate the degree of immune priming in this regimen compared descriptively to TRIO Trial

Time frame
Measured 3 to 8 days after last dose of pembrolizumab. Which is Day 20-25, where blood and tissue will be collected.
2

Breast and skin tissue adverse events to evaluate toxicity of treatment

Toxicity to surrounding breast and skin tissue, defined by ≥ grade 2 fibrosis.

Time frame
Baseline, 3 weeks post-op, 6 months post-op, 1 year post-op
3

Treatment related adverse event

Adverse events relating to the interventional radiation or pembrolizumab defined by ≥ grade 3

Time frame
Measured at up to surgery, typically 6 months after enrolment in trial.
4

Local Recurrence Rates

Ipsilateral breast recurrence rate.

Time frame
Disease status will be evaluated at routine patient follow-up appointments, including yearly mammography. Will be recorded at Year 1, Year 2, Year 3, Year 4, Year 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov
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