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PARP Inhibitor

Talazoparib + Avelumab for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Claudine Isaacs, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically confirmed advanced breast cancer not amenable to curative treatment by surgery or radiotherapy, that is amenable to biopsy
Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a new cancer treatment combining two drugs. It will assess how well the treatment works and how safe it is.

Who is the study for?
This trial is for adults with advanced breast cancer that can't be cured by surgery or radiation, who are in good physical condition (ECOG 0-1), and have a life expectancy over 3 months. They must not have used PARP inhibitors before, no recent severe infections or certain chronic diseases like HIV or hepatitis B, and no history of serious allergic reactions to similar drugs. Women must not be pregnant and should agree to contraception.Check my eligibility
What is being tested?
The TALAVE trial tests the safety of Talazoparib alone first (induction phase) followed by its combination with Avelumab in treating advanced breast cancer. The study also looks at how this treatment might affect the body's immune response to cancer.See study design
What are the potential side effects?
Possible side effects include fatigue, nausea, blood cell count changes which could lead to increased infection risk or bleeding problems, potential heart issues due to ECG changes required for eligibility screening, and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced breast cancer cannot be cured with surgery or radiotherapy, but it can be biopsied.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have had treatments before, but my last treatment was at least 2 weeks ago.
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I have fully recovered from my recent surgery.
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I agree to have multiple biopsies during the study.
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I am not pregnant or have been without a menstrual period for at least 12 months.
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I, or my legal representative, can understand and follow the study's requirements and have signed the consent form.
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I am 18 years old or older.
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I can swallow pills whole.
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My liver, kidneys, and blood cells are functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Quantification of Grade 3 and 4 toxicities (Adverse Events)
Secondary outcome measures
The anti-tumor efficacy as measured by Objective Response Rate (ORR).
Other outcome measures
The anti-tumor efficacy as measured by Disease Control Rate (DCR).
The anti-tumor efficacy as measured by Duration of Response (DOR).
The anti-tumor efficacy as measured by Overall Survival (OS).
+1 more

Side effects data

From 2018 Phase 1 & 2 trial • 40 Patients • NCT02116777
89%
Anemia
78%
Alkaline phosphatase increased
78%
Nausea
78%
White blood cell decreased
67%
Fatigue
67%
Lymphocyte count decreased
56%
Aspartate aminotransferase increased
56%
Hypermagnesemia
56%
Headache
56%
Neutrophil count decreased
56%
Platelet count decreased
56%
Pain in extremity
44%
Constipation
44%
Hypoalbuminemia
44%
Non-cardiac chest pain
44%
Hyponatremia
33%
Creatinine increased
33%
Hypocalcemia
33%
Anorexia
33%
Back pain
33%
Diarrhea
33%
Alanine aminotransferase increased
33%
Alopecia
33%
Blood bilirubin increased
33%
Dizziness
33%
Fever
33%
Hyperglycemia
33%
Pain
33%
Proteinuria
33%
Sinus tachycardia
33%
Vomiting
22%
Cough
22%
Hypokalemia
22%
Abdominal pain
22%
Dyspnea
22%
Hypercalcemia
22%
Hypernatremia
22%
Hypophosphatemia
22%
Hypotension
22%
Hypoxia
22%
Nasal congestion
22%
Neck pain
11%
Tumor pain
11%
Allergic reaction
11%
Weight loss
11%
Febrile neutropenia
11%
Periorbital infection
11%
Eye disorders - Other, LEFT ORBITAL RECONSTRUCTION
11%
Edema limbs
11%
Irregular menstruation
11%
Bone pain
11%
Dysgeusia
11%
Hemoglobin increased
11%
Musculoskeletal and connective tissue disorder - Other, LARGE OCCIPITAL SKULL DEFECT
11%
Skin and subcutaneous tissue disorders - Other, ERYTHEMA
11%
Urinary urgency
11%
Renal and urinary disorders - Other, BLADDER PAIN
11%
Anxiety
11%
Avascular necrosis
11%
Depression
11%
Hypomagnesemia
11%
Respiratory, thoracic and mediastinal disorders - Other, OBSTRUCTIVE SLEEP APNEA
11%
Edema face
11%
Hematuria
11%
Lymphocyte count increased
11%
Activated partial thromboplastin time prolonged
11%
Cardiac disorders - Other, NON RESTRICTIVE CARDIOMYOPATHY
11%
Cystitis noninfective
11%
Epistaxis
11%
Gait disturbance
11%
Gastroesophageal reflux disease
11%
Hypertension
11%
Infections and infestations - Other, SHINGLES ZOSTER
11%
Insomnia
11%
Investigations - Other, BICARBONATE DECREASED
11%
Investigations - Other, BICARBONATE INCREASED
11%
Investigations - Other, BICARBONATE LOW
11%
Metabolism and nutrition disorders - Other, CHLORIDE LEVEL
11%
Mucosal infection
11%
Muscle weakness right-sided
11%
Pericardial effusion
11%
Pleural effusion
11%
Rash acneiform
11%
Respiratory, thoracic and mediastinal disorders - Other, ASTHMA
11%
Skin hyperpigmentation
11%
Skin ulceration
11%
Stomach pain
11%
Thromboembolic event
11%
Tinnitus
11%
Urinary retention
11%
Obesity
100%
80%
60%
40%
20%
0%
Study treatment Arm
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day
400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase I/Phase IIExperimental Treatment2 Interventions
Talazoparib (1mg by mouth [PO] daily D1-28) will be provided as monotherapy for the first cycle. Starting with cycle 2 and for all subsequent cycles, treatment with avelumab (800 mg intravenously [IV] D1 every 2 weeks) will be added to talazoparib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
2021
Completed Phase 2
~2740
Avelumab
2018
Completed Phase 2
~2450

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
341 Previous Clinical Trials
126,478 Total Patients Enrolled
33 Trials studying Breast Cancer
13,061 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,556 Previous Clinical Trials
10,907,659 Total Patients Enrolled
110 Trials studying Breast Cancer
34,646 Patients Enrolled for Breast Cancer
Claudine Isaacs, MDPrincipal InvestigatorGeorgetown University
5 Previous Clinical Trials
144 Total Patients Enrolled
2 Trials studying Breast Cancer
67 Patients Enrolled for Breast Cancer

Media Library

Talazoparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03964532 — Phase 1 & 2
Breast Cancer Research Study Groups: Phase I/Phase II
Breast Cancer Clinical Trial 2023: Talazoparib Highlights & Side Effects. Trial Name: NCT03964532 — Phase 1 & 2
Talazoparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03964532 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of people participating in this medical experiment?

"Presently, this clinical trial is not seeking candidates. It was initially posted on April 17th 2019 and last updated October 10th 2022. Those in search of other studies may be interested to know that there are 2596 trials actively recruiting breast cancer patients and 162 trials for Talazoparib currently searching for participants."

Answered by AI

Is recruitment for this research still open?

"Currently, no new participants are needed for this particular trial which was first posted in April 2019 and most recently updated on October 10th 2022. If you're looking for other opportunities to participate in clinical trials related to breast cancer, there are 2596 active studies available; those interested in Talazoparib can find 162 separate medical research initiatives enrolling now."

Answered by AI

What is the purpose of Talazoparib consumption?

"Talazoparib is often utilized to manage advanced directives, as well as brca1 gene mutations, merkel cell carcinoma and several types of malignant neoplasms."

Answered by AI

What other investigations have been conducted on Talazoparib?

"Talazoparib was initially researched at City of Hope in 2010, and since then over 70 clinical trials have been completed. Currently 162 active studies are being conducted with a significant presence in Washington D.C.."

Answered by AI
~4 spots leftby Mar 2025