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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years of study treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can carry out all my usual activities without help.
Select...
My breast cancer is positive for estrogen or progesterone receptors.
Select...
My cancer cannot be surgically removed, has spread, and needs chemotherapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years of study treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years of study treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To describe the safety and tolerability of the combinations of pelareorep, paclitaxel and avelumab as graded by the NCI CTCAE v. 5.0.
Other outcome measures
Changes in the peripheral and tumor T cell clonality.
Overall Survival
Overall response rate
Side effects data
From 2020 Phase 2 trial • 108 Patients • NCT0119926392%
Anemia
85%
Nausea
85%
Fatigue
81%
White Blood Cell Decreased
75%
Neutrophil Count Decreased
71%
Constipation
69%
Alopecia
63%
Chills
63%
Peripheral Sensory Neuropathy
58%
Platelet Count Decreased
58%
Dyspnea
52%
Fever
52%
Anorexia
52%
Diarrhea
48%
Hypoalbuminemia
46%
Abdominal Pain
46%
Vomiting
40%
Pain
38%
Hypertension
37%
Headache
37%
Hyperglycemia
35%
Flu Like Symptoms
35%
Cough
31%
Mucositis Oral
31%
Hypocalcemia
31%
Depression
29%
Hyponatremia
29%
Back Pain
29%
Edema Limbs
27%
Hypomagnesemia
27%
Creatinine Increased
25%
Myalgia
23%
Dizziness
23%
Insomnia
21%
Anxiety
21%
Urinary Tract Infection
19%
Bloating
19%
Arthralgia
19%
Generalized Muscle Weakness
19%
Nasal Congestion
17%
Hypokalemia
17%
Urinary Frequency
15%
Pruritus
15%
Non-Cardiac Chest Pain
15%
Aspartate Aminotransferase Increased
15%
Alkaline Phosphatase Increased
13%
Dehydration
13%
Pain In Extremity
13%
Hypotension
13%
Epistaxis
13%
Hot Flashes
12%
Rash Maculo-Papular
12%
Blurred Vision
12%
Urinary Tract Pain
12%
Alanine Aminotransferase Increased
12%
Flushing
10%
Sinus Tachycardia
10%
Neoplasms Benign, Malignant And Unspecified (Incl
10%
Atrial Fibrillation
10%
Abdominal Distension
10%
Sinusitis
10%
Hypophosphatemia
10%
Dry Skin
10%
Nail Loss
10%
Hyperkalemia
10%
Pleural Effusion
10%
Productive Cough
10%
Nail Discoloration
10%
Ascites
8%
Hoarseness
8%
Small Intestinal Obstruction
8%
Dysphagia
8%
Allergic Rhinitis
8%
Hypermagnesemia
8%
Lymphocyte Count Decreased
8%
Postnasal Drip
8%
Urinary Incontinence
8%
Weight Loss
8%
Thromboembolic Event
6%
Stomach Pain
6%
Enterocolitis Infectious
6%
Blood Bilirubin Increased
6%
Edema Face
6%
Vaginal Infection
6%
Weight Gain
6%
Sore Throat
6%
Hematuria
6%
Dysgeusia
6%
Inr Increased
6%
Activated Partial Thromboplastin Time Prolonged
6%
Hypoxia
6%
Localized Edema
4%
Lung Infection
4%
Intra-Abdominal Hemorrhage
4%
Flashing Lights
4%
Chest Pain - Cardiac
4%
Palpitations
4%
Tinnitus
4%
Gastroesophageal Reflux Disease
4%
Malaise
4%
Infusion Related Reaction
4%
Allergic Reaction
4%
Upper Respiratory Infection
4%
Skin Infection
4%
Hypoglycemia
4%
Sinus Disorder
4%
Confusion
4%
Chest Wall Pain
4%
Neck Pain
4%
Syncope
4%
Ear Pain
4%
Peripheral Motor Neuropathy
4%
Hyperhidrosis
4%
Acute Kidney Injury
2%
Infusion Site Extravasation
2%
Febrile Neutropenia
2%
Sinus Bradycardia
2%
Myocardial Infarction
2%
Purpura
2%
Gastritis
2%
Cataract
2%
Vaginal Hemorrhage
2%
Retinopathy
2%
Floaters
2%
Sepsis
2%
Intracranial Hemorrhage
2%
Ventricular Tachycardia
2%
Hip Fracture
2%
Gallbladder Pain
2%
Pharyngitis
2%
Dyspepsia
2%
Rectal Hemorrhage
2%
Oral Pain
2%
Flatulence
2%
Enterocolitis
2%
Wound Infection
2%
Anal Fistula
2%
Salivary Gland Infection
2%
Gum Infection
2%
Upper Gastrointestinal Hemorrhage
2%
Fecal Incontinence
2%
Mucosal Infection
2%
Conjunctivitis Infective
2%
Oral Hemorrhage
2%
Injection Site Reaction
2%
Gastroparesis
2%
Hepatobiliary Disorders - Other
2%
Gait Disturbance
2%
Pelvic Pain
2%
Gallbladder Obstruction
2%
Pulmonary Hypertension
2%
Nail Infection
2%
Nail Ridging
2%
Suicidal Ideation
2%
Acidosis
2%
Muscle Weakness Lower Limb
2%
Lymphedema
2%
Pain Of Skin
2%
Hypernatremia
2%
Respiratory Failure
2%
Palmar-Plantar Erythrodysesthesia Syndrome
2%
Sneezing
2%
Presyncope
2%
Paresthesia
2%
Akathisia
2%
Hypercalcemia
2%
Lethargy
2%
Arthritis
2%
Urinary Urgency
2%
Facial Muscle Weakness
2%
Ataxia
2%
Movements Involuntary
2%
Urinary Tract Obstruction
2%
Erythema Multiforme
2%
Superficial Thrombophlebitis
2%
Pneumothorax
2%
Watering Eyes
2%
Laryngitis
2%
Bladder Infection
2%
Postoperative Hemorrhage
2%
Fall
2%
Bruising
2%
Depressed Level Of Consciousness
2%
Cognitive Disturbance
2%
Pneumonitis
2%
Sleep Apnea
2%
Wheezing
2%
Adrenal Insufficiency
2%
Burn
2%
Chronic Kidney Disease
2%
Vaginal Pain
2%
Agitation
2%
Skin And Subcutaneous Tissue Disorders - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (Paclitaxel and Wild-type Reovirus)
Arm I (Paclitaxel)
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
~150
Avelumab
2018
Completed Phase 2
~2450
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Oncolytics BiotechLead Sponsor
20 Previous Clinical Trials
949 Total Patients Enrolled
1 Trials studying Breast Cancer
26 Patients Enrolled for Breast Cancer
PrECOG, LLC.OTHER
17 Previous Clinical Trials
7,410 Total Patients Enrolled
1 Trials studying Breast Cancer
5,796 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radiation treatment in the last 14 days.I do not have active brain metastases or related conditions.My cancer progressed after hormone therapy including a CDK4/6 inhibitor.I haven't taken any experimental cancer treatments in the last 30 days.I cannot take paclitaxel or have severe nerve pain or damage.I can carry out all my usual activities without help.My recent tests show my organs are working well.I can understand and am willing to sign the consent form.I have received chemotherapy for cancer that has spread.My breast cancer is positive for estrogen or progesterone receptors.I have had cancer before, but it was either skin cancer treated successfully or any cancer treated over 3 years ago with no current signs of disease.I am legally unable to make my own decisions.I do not have any major health issues that could affect my treatment.I have or had an autoimmune disease or immunodeficiency.I have heart problems that are not well-managed.I agree to use two forms of birth control or abstain from sex during and for 3 months after the study.I do not have any serious health or mental conditions that could stop me from completing the treatment.I am a woman aged 18 or older.I have not had major surgery in the last 3 weeks.I have previously received immunotherapy for breast cancer.My cancer cannot be surgically removed, has spread, and needs chemotherapy.I have an active hepatitis B or C infection or am receiving treatment for it.I am on long-term medication to suppress my immune system.I am HIV positive.I am still experiencing side effects from my previous cancer treatment.I have not been vaccinated within 14 days before starting the treatment cycle.You have a history of alcohol or drug abuse.My cancer does not show high levels of HER2, or it's unclear but HER2 treatment isn't right for me.You have a disease that can be measured using a specific set of guidelines.I may or may not have had mTOR inhibitor therapy before.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1
- Group 2: Cohort 3
- Group 3: Cohort 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings available for participants in this experiment?
"The clinicaltrials.gov website states that this specific trial, which was initially posted on June 10th 2020 and last updated September 1st 2022, is not recruiting anymore. Fortunately, there are still over 3200 trials actively accepting patients at the present moment."
Answered by AI
Have there been any other investigations examining the effects of Pelareorep?
"Pelareorep first emerged as a viable medical treatment in 1997 when it was studied at City of Hope Comprehensive Cancer Center. Since then, 1192 completed trials have taken place and 935 are currently recruiting patients from across the United States; Miami has notably become a hub for these trial sites."
Answered by AI
What is the extent of implementation for this trial?
"Currently, 19 medical centres are participating in this clinical trial. A few of the more well-known sites include University of Miami Sylvester Comprehensive Cancer Center in Miami, Carle Cancer Center in Urbana and Ochsner Clinic Foundation in New Orleans. The other 16 locations can be found on clinicialtrials.gov"
Answered by AI
What is the density of participants in this trial?
"Unfortunately, no new patients are being recruited for this trial at the moment. The study was initially posted on 10th June 2020 and its last update was on 1st September 2022. However, there is a wealth of other research studies looking to recruit breast cancer patients (2290) as well as those with Pelareorep (935)."
Answered by AI
For what therapeutic purposes is Pelareorep regularly prescribed?
"Pelareorep is usually employed to battle esophageal neoplasms malignant. Additionally, it has been demonstrated to effectively address conditions such as malignant peritoneal neoplasm, non-small cell lung carcinoma (nsclc), and metastatic neoplasia."
Answered by AI
What potential risks should be considered prior to administering Pelareorep?
"As it is only at Phase 2, there is some data to suggest the safety of Pelareorep but not efficacy. Our team ranks this as a score of two on our scale."
Answered by AI
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