AzTrials
AzTrials

Breast Cancer MetastaticPhase 2NCT04215146

A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study

A Phase 2 study testing Paclitaxel, Pelareorep and Avelumab in people with Breast Cancer Metastatic, run by Oncolytics Biotech at 18 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer Metastatic
What is being tested?
Paclitaxel, Pelareorep and Avelumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
18 sitesUnited States
Study dates
10 Jun 2020to Jun 2025
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female patients ≥ 18 years of age at the time of signing the informed consent form (ICF).
  • Must have a histological/cytological diagnosis of breast cancer. Disease must be:
  • Positive for estrogen receptor (ER) and/or progesterone receptor (PgR) as defined by
  • ≥ 1% tumor cell nuclei immunoreactive.
  • Negative for HER2 amplification / overexpression as defined per the American Society of Clinical Oncology - College of American Pathologists (ASCO-CAP) guidelines. However, patients with HER2 equivocal disease for whom HER2 targeted therapy isn't indicated are also eligible for enrollment.
  • ECOG performance status of 0-1
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  • Must have unresectable locally advanced or metastatic disease, for which no curative therapy exists and for which systemic chemotherapy is indicated.
  • Measurable disease as defined by RECIST Version 1.1
  • Prior Hormonal Therapy:
  • Patients must have progressed on at least 1 hormone-based therapy with a CDK4/6 inhibitor. Patients who received a CDK4/6 inhibitor in the adjuvant setting and progressed while on or within 6 months of discontinuation of CDK4/6 inhibitor therapy are eligible.
  • Prior mTOR inhibitor therapy is allowed but is not required.
  • Ability to understand and willingness to sign IRB-approved informed consent.
  • Willing to provide blood samples for research
  • Adequate organ function as measured by the following criteria, obtained ≤ 2 weeks prior to registration:
  • Hematology:
  • Neutrophils ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • Lymphocytes ≥ 0.8 x 10^9/L
  • INR < 1.5x ULN (Unless on therapeutic anticoagulation)
  • PTT < 1.5x ULN
  • Biochemistry:
  • Serum Creatinine ≤ 1.5x ULN
  • Total Bilirubin ≤ 1.0x ULN (unless due to Gilbert's Disease and direct bilirubin <ULN)
  • ALT and AST ≤ 3x ULN (Note: ≤ 5x ULN if documented liver metastasis)
  • Proteinuria ≤ Grade 2* (using spot testing; if Grade 3 repeat with mid-stream urine; if still Grade 3 then urine collection for 24 hours to confirm Grade 0, 1 or 2) *as per National Cancer Institute Common Terminology Criteria for Adverse (NCI-CTCAE)
  • Women must not be pregnant or breastfeeding since we do not know the effects of the study drugs on the fetus or breastfeeding child. All sexually active females of childbearing potential (not surgically sterilized and between menarche and 1 year post menopause) must have a blood test to rule out pregnancy within 2 weeks prior to registration.
  • Sexually active women of child-bearing potential with a non-sterilized male partner must agree to use 2 methods of adequate contraception (hormonal plus barrier or 2 barrier forms) OR abstinence prior to study entry, for the duration of study participation, and for 3 months following last dose of study drugs. Method of contraception must be documented. NOTE: If a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.

Who cannot join

  • No major surgery within 21 days prior to beginning study treatment. Major surgery >21 days prior to beginning study treatment is permitted provided that the patient has recovered adequately to receive systemic chemotherapy. NOTE: Placement of a vascular access device is not considered major surgery.
  • Patients who have received radiation treatment within 14 days of beginning study treatment are excluded. Patients who have received palliative radiation ≥ 14 days prior to beginning study treatment may enroll if they have recovered from all local and systemic side effects to ≤ Grade 1 (NCI-CTCAE).
  • No prior chemotherapy in the advanced/metastatic setting is allowed. Patients may have received chemotherapy in the (neo)adjuvant setting. Patients receiving (neo)adjuvant taxanes must have a disease-free interval of at least 12 months.
  • No known active, uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms,cerebral edema, and/or progressive growth. Patients with CNS metastases treated with radiation therapy (Whole-Brain Radiation Therapy [WBXRT] or Stereotactic Radiotherapy [SRS]) are eligible if, >28 days following completion of XRT, they show stable disease on post-treatment MRI/CT, are off corticosteroids, and are neurologically stable.
  • No known history of other malignancies, except for adequately treated non-melanoma skin cancer or solid tumors curatively treated with no evidence of disease for >3 years.
  • Not on chronic immunosuppressive therapy including, but not exclusively, steroids (≥ 10 mg prednisone a day or equivalent) or monoclonal antibodies, chronic methotrexate or cyclophosphamide, tacrolimus or sirolimus.
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  • No known HIV infection. Testing not required in absence of clinical suspicion.
  • No known active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection or undergoing anti-viral treatment. Testing for HBV/HCV is not required in absence of clinical suspicion.
  • No concurrent disease or condition that would interfere with study participation or safety,such as any of the following:
  • Active, clinically significant infection either Grade >2 by CTCAE V5.0 or requiring the use of parenteral anti-microbial agents within 14 days before registration.
  • No active or history of any autoimmune disease (patients with diabetes Type 1, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.
  • Patients may not have evidence of uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, symptomatic congestive heart failure (New York Heart Association [NYHA] Class III or higher), unstable angina, or myocardial infarction within the past 6 months prior to registration. NOTE: Patients with asymptomatic rate-controlled atrial fibrillation may participate.
  • Patients may not have other significant diseases (for example, inflammatory bowel disease), which, in the opinion of the Investigator, might impair the patient's tolerance of trial treatment.
  • Patients with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible.
  • Patients who have contraindications to treatment with paclitaxel and/or neuropathy >Grade 2 are not eligible.
  • Patients who have not recovered from clinically significant acute toxicities of previous therapy are not eligible, except treatment-related alopecia or stable sensory neuropathy ≤ Grade 2.
  • No prior therapy with any investigational anti-cancer therapy within 30 days. Prior immunotherapies are prohibited.
  • No prior therapy with checkpoint inhibitors (e.g., anti-PD-1/PD-L1 antibodies), checkpoint agonist agents (e.g., anti-GITR, anti-OX40 antibodies) and/or another active immunotherapy in breast cancer such as cancer vaccines or oncolytic virsus.
  • Patients with any serious medical or psychiatric illness that could, in the Investigator's opinion, potentially interfere with the completion of the treatment according to the protocol, are not eligible.
  • Patients with legal incapacity or limited legal capacity are not eligible.
  • Patients with known alcohol or drug abuse are not eligible.
  • Patients may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial, throughout the duration of this study.
  • Patients may not have any vaccine, including against SARS-COV-2 (COVID-19) <14 days prior to Cycle 1 Day 1 nor in the first cycle of study treatment. Inactivated vaccines (including against COVID-19 or seasonal influenza) are permitted after the first cycle of study treatment is complete.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • Roswell Park

    Buffalo, New York, 14263

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

  • University of Miami Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital, Sidney Kimmel Cancer Center

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • VCU/Massey Cancer Center

    Richmond, Virginia, 23298

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Montefiore Medical Park

    The Bronx, New York, 10461

  • Carle Cancer Center

    Urbana, Illinois, 61801

Other trials in United States

About this study

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.

Read the detailed description

This is an open-label randomized Phase 2, 3-cohort study to evaluate the safety and efficacy of pelareorep, paclitaxel and avelumab in Hormone Receptor+ (HR+)/Human Epidermal Growth Factor Receptor 2 negative (HER2-) with endocrine-refractory metastatic breast cancer.

Patients will be randomized to one of three treatment cohorts: paclitaxel alone, pelareorep + paclitaxel, or pelareorep + paclitaxel + avelumab. A three patient safety run-in will be conducted in the cohort for pelareorep + paclitaxel + avelumab prior to beginning randomization into all three cohorts.

Patients will give mandatory blood samples and optional tumor biopsies, which will be analyzed for biomarkers to determine the immunological changes within the tumor microenvironment and peripheral blood in patients treated with paclitaxel alone, in combination with pelareorep, and in combination with pelareorep and avelumab.

Being tested
Paclitaxel, Pelareorep, Avelumab
Keywords
Breast, Breast Cancer, Breast Cancer Metastatic, Locally Advanced Breast Cancer, Pelareorep, Avelumab, Paclitaxel, Reovirus, Oncolytic virus, HR+ breast cancer, HER2- breast cancer, Breast malignancy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Paclitaxel 80 mg/m^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.

  • PelareorepBiological

    Pelareorep 4.5 x 10^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.

  • AvelumabDrug

    Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.

Study groups in NCT04215146
Study groupRoleWhat they receive
Cohort 1Active comparatorPatients receive paclitaxel alone.
Receives: Drug: Paclitaxel
Cohort 2ExperimentalPatients receive pelareorep + paclitaxel.
Receives: Drug: Paclitaxel; Biological: Pelareorep
Cohort 3ExperimentalPatients receive pelareorep + paclitaxel + avelumab.
Receives: Drug: Paclitaxel; Biological: Pelareorep; Drug: Avelumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Response Rate

    Overall response rate at week 16 according to RECIST V1.1

    Measured: at week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2020
  2. Study start10 Jun 2020
  3. Primary completion1 Aug 2022
  4. Study completionJun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04215146
Sponsor's protocol ID
REO 028
Other IDs
PrE0113
Status last verified
Jan 2025
First submitted
24 Dec 2019
Last updated
16 Jan 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Pelareorep and Avelumab in people with Breast Cancer Metastatic, run by Oncolytics Biotech at 18 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: at week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04215146.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.

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