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PD-L1 Inhibitor

Pelareorep + Chemotherapy + Avelumab for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Oncolytics Biotech
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0-1
Must have a histological/cytological diagnosis of breast cancer that is positive for estrogen receptor (ER) and/or progesterone receptor (PgR) as defined by ≥ 1% tumor cell nuclei immunoreactive
Must not have
Radiation treatment within 14 days of beginning study treatment
Known active, uncontrolled or symptomatic Central Nervous System (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years of study treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the possible anti-cancer effect of pelareorep in combination with chemotherapy and avelumab in treating HR+/HER2- breast cancer.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects include typical reactions from chemotherapy like nausea, fatigue, hair loss; immune-related issues such as inflammation from avelumab; and flu-like symptoms possibly caused by pelareorep.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can carry out all my usual activities without help.
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My breast cancer is positive for estrogen or progesterone receptors.
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My cancer cannot be surgically removed, has spread, and needs chemotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had radiation treatment in the last 14 days.
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I do not have active brain metastases or related conditions.
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I haven't taken any experimental cancer treatments in the last 30 days.
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I cannot take paclitaxel or have severe nerve pain or damage.
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I have received chemotherapy for cancer that has spread.
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I am legally unable to make my own decisions.
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I have or had an autoimmune disease or immunodeficiency.
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I have heart problems that are not well-managed.
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I have previously received immunotherapy for breast cancer.
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I have an active hepatitis B or C infection or am receiving treatment for it.
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I am on long-term medication to suppress my immune system.
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I am HIV positive.
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I have not been vaccinated within 14 days before starting the treatment cycle.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years of study treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To describe the safety and tolerability of the combinations of pelareorep, paclitaxel and avelumab as graded by the NCI CTCAE v. 5.0.
Other study objectives
Changes in the peripheral and tumor T cell clonality.
Overall Survival
Overall response rate

Side effects data

From 2020 Phase 2 trial • 108 Patients • NCT01199263
90%
Anemia
83%
Fatigue
73%
Nausea
73%
White Blood Cell Decreased
73%
Alopecia
63%
Peripheral Sensory Neuropathy
58%
Constipation
52%
Neutrophil Count Decreased
50%
Dyspnea
48%
Abdominal Pain
46%
Anorexia
44%
Hypoalbuminemia
42%
Diarrhea
42%
Vomiting
38%
Edema Limbs
38%
Depression
35%
Hyperglycemia
33%
Hypocalcemia
31%
Hyponatremia
31%
Hypertension
27%
Urinary Tract Infection
27%
Creatinine Increased
25%
Arthralgia
25%
Cough
23%
Platelet Count Decreased
23%
Aspartate Aminotransferase Increased
23%
Hypomagnesemia
23%
Headache
23%
Insomnia
21%
Bloating
21%
Mucositis Oral
21%
Hypokalemia
21%
Anxiety
21%
Rash Maculo-Papular
21%
Hot Flashes
19%
Pain
19%
Alkaline Phosphatase Increased
19%
Dehydration
19%
Generalized Muscle Weakness
19%
Dizziness
17%
Urinary Frequency
17%
Bone Pain
17%
Back Pain
15%
Blurred Vision
15%
Abdominal Distension
15%
Fever
15%
Alanine Aminotransferase Increased
15%
Nasal Congestion
13%
Small Intestinal Obstruction
13%
Tinnitus
13%
Dyspepsia
13%
Non-Cardiac Chest Pain
13%
Lymphocyte Count Decreased
13%
Pain In Extremity
13%
Pruritus
13%
Hypotension
10%
Ascites
10%
Localized Edema
10%
Urinary Urgency
10%
Urinary Tract Pain
10%
Sore Throat
10%
Postnasal Drip
10%
Allergic Rhinitis
10%
Nail Discoloration
8%
Urinary Incontinence
8%
Ear Pain
8%
Chills
8%
Weight Loss
8%
Weight Gain
8%
Activated Partial Thromboplastin Time Prolonged
8%
Hypernatremia
8%
Chest Wall Pain
8%
Dysgeusia
8%
Nail Loss
8%
Thromboembolic Event
8%
Flushing
6%
Palpitations
6%
Hearing Impaired
6%
Fall
6%
Blood Bilirubin Increased
6%
Hypophosphatemia
6%
Hypoglycemia
6%
Hyperkalemia
6%
Myalgia
6%
Proteinuria
4%
Chest Pain - Cardiac
4%
Eye Pain
4%
Cognitive Disturbance
4%
Sinus Tachycardia
4%
Cataract
4%
Dry Mouth
4%
Rectal Hemorrhage
4%
Gastroesophageal Reflux Disease
4%
Toothache
4%
Esophagitis
4%
Gastritis
4%
Esophageal Pain
4%
Flu Like Symptoms
4%
Allergic Reaction
4%
Upper Respiratory Infection
4%
Skin Infection
4%
Sinusitis
4%
Sepsis
4%
Bruising
4%
Inr Increased
4%
Hypermagnesemia
4%
Hypertriglyceridemia
4%
Tremor
4%
Flank Pain
4%
Arthritis
4%
Peripheral Motor Neuropathy
4%
Memory Impairment
4%
Dysphasia
4%
Restlessness
4%
Confusion
4%
Urinary Retention
4%
Hematuria
4%
Vaginal Hemorrhage
4%
Pleural Effusion
4%
Dry Skin
4%
Rash Acneiform
2%
Extraocular Muscle Paresis
2%
Floaters
2%
Akathisia
2%
Vaginal Discharge
2%
Colonic Perforation
2%
Stoma Site Infection
2%
Lung Infection
2%
Neoplasms Benign, Malignant And Unspecified (Incl
2%
Acute Kidney Injury
2%
Leukocytosis
2%
Acute Coronary Syndrome
2%
Flashing Lights
2%
Dysphagia
2%
Conjunctivitis
2%
Colitis
2%
Ileus
2%
Rectal Mucositis
2%
Gastric Hemorrhage
2%
Oral Pain
2%
Rectal Pain
2%
Esophageal Hemorrhage
2%
Malaise
2%
Edema Trunk
2%
Facial Pain
2%
Edema Face
2%
Infusion Related Reaction
2%
Soft Tissue Infection
2%
Peritoneal Infection
2%
Otitis Media
2%
Papulopustular Rash
2%
Esophageal Infection
2%
Bronchial Infection
2%
Fracture
2%
Cholesterol High
2%
Urine Output Decreased
2%
Hyperuricemia
2%
Hypercalcemia
2%
Acidosis
2%
Neck Pain
2%
Muscle Weakness Lower Limb
2%
Sinus Pain
2%
Agitation
2%
Urinary Tract Obstruction
2%
Pelvic Pain
2%
Vaginal Dryness
2%
Breast Pain
2%
Epistaxis
2%
Nail Ridging
2%
Palmar-Plantar Erythrodysesthesia Syndrome
2%
Bullous Dermatitis
2%
Lymphedema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm I (Paclitaxel)
Arm II (Paclitaxel and Wild-type Reovirus)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pelareorep
2010
Completed Phase 2
~160
Avelumab
2017
Completed Phase 2
~2440
Paclitaxel
2011
Completed Phase 4
~5450

Find a Location

Who is running the clinical trial?

Oncolytics BiotechLead Sponsor
20 Previous Clinical Trials
949 Total Patients Enrolled
PrECOG, LLC.OTHER
18 Previous Clinical Trials
7,948 Total Patients Enrolled

Media Library

Avelumab (PD-L1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04215146 — Phase 2
Breast cancer Research Study Groups: Cohort 1, Cohort 3, Cohort 2
Breast cancer Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT04215146 — Phase 2
Avelumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04215146 — Phase 2
~9 spots leftby Nov 2025
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