Pelareorep + Chemotherapy + Avelumab for Breast Cancer

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Oncolytics Biotech

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy \[paclitaxel\] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 negative(HER2-) breast cancer, which is either locally advanced or has metastasized (cancer that has spread in your body). The study will investigate if pelareorep in combination with paclitaxel and avelumab is more effective than paclitaxel alone, or pelareorep and paclitaxel. The safety of the combination treatments will also be evaluated.

Research Team

Eligibility Criteria

This trial is for women over 18 with advanced or metastatic HR+/HER2- breast cancer that has worsened after hormone therapy and a CDK4/6 inhibitor. Participants must have good performance status, not be pregnant or breastfeeding, agree to use contraception if of childbearing potential, and cannot have other active cancers or certain health conditions.

Inclusion Criteria

My cancer progressed after hormone therapy including a CDK4/6 inhibitor.

I can carry out all my usual activities without help.

My recent tests show my organs are working well.

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Exclusion Criteria

I have not had radiation treatment in the last 14 days.

I do not have active brain metastases or related conditions.

I haven't taken any experimental cancer treatments in the last 30 days.

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Treatment Details

Interventions

Avelumab (PD-L1 Inhibitor)
Paclitaxel (Anti-microtubule agent)
Pelareorep (Virus Therapy)

Trial OverviewThe BRACELET-1 study tests the effectiveness of pelareorep combined with paclitaxel chemotherapy and avelumab immunotherapy against breast cancer compared to paclitaxel alone or with pelareorep. It aims to see if this combination can better control the spread of cancer.

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Cohort 3Experimental Treatment3 Interventions

Patients receive pelareorep + paclitaxel + avelumab.

Group II: Cohort 2Experimental Treatment2 Interventions

Patients receive pelareorep + paclitaxel.

Group III: Cohort 1Active Control1 Intervention

Patients receive paclitaxel alone.

Avelumab is already approved in Japan for the following indications: