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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
Must not have
Prior exposure to PARP inhibitor-based therapy
Diagnosis of immunodeficiency or is receiving systemic steroid or other immunosuppressive therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

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.
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.
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, 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been treated with PARP inhibitors before.
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I have an immune system disorder or am taking medication that weakens my immune system.
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I have not had major heart problems or strokes in the last 6 months.
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I have a history of specific lung conditions or signs of lung inflammation on a CT scan.
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I am not pregnant or breastfeeding.
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I have not had any cancer except for non-melanoma skin cancer in the last 2 years.
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I haven't had radiation on more than 20% of my bone marrow.
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My condition worsened within 6 months while on anti-PD-1 or PD-L1 therapy.
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I have not had a severe infection, recent antibiotics, or chronic HIV or hepatitis B.
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I have brain metastases that have not been treated.
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I have had a bone marrow or organ transplant.
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I do not have any severe illnesses that would make it unsafe for me to join the study.
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I have had tuberculosis in the past.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quantification of Grade 3 and 4 toxicities (Adverse Events)
Secondary study objectives
The anti-tumor efficacy as measured by Objective Response Rate (ORR).
Other study objectives
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
100%
Fatigue
100%
Headache
67%
Hyperglycemia
67%
Platelet count decreased
67%
Anemia
67%
Back pain
33%
Blurred vision
33%
Sinus tachycardia
33%
Alanine aminotransferase increased
33%
Insomnia
33%
Neutrophil count decreased
33%
Gastroesophageal reflux disease
33%
Investigations - Other, ALT DECREASED
33%
Hyponatremia
33%
Hypothyroidism
33%
Urinary incontinence
33%
Gait disturbance
33%
White blood cell decreased
33%
Nervous system disorders - Other, PARALYSIS
33%
Peripheral motor neuropathy
33%
Creatinine increased
33%
Nausea
33%
Scoliosis
33%
Hypertension
33%
Hypoglycemia
33%
Hypokalemia
33%
Weight loss
33%
Peripheral sensory neuropathy
33%
Alopecia
33%
Diarrhea
33%
Hypermagnesemia
33%
Lymphocyte count decreased
33%
Hypophosphatemia
33%
Skin ulceration
33%
Muscle weakness lower limb
33%
Cough
33%
Non-cardiac chest pain
33%
Nystagmus
33%
Skin infection
33%
Aspartate aminotransferase increased
33%
Investigations - Other, BUN DECREASED
33%
Arthralgia
33%
Edema limbs
33%
Nervous system disorders - Other, HYPOTONIC
33%
Chills
33%
Investigations - Other, AST DECREASED
33%
Constipation
33%
Fever
33%
Pain in extremity
33%
Alkaline phosphatase increased
33%
Neuralgia
33%
Skin and subcutaneous tissue disorders - Other, LEFT LOWER LEG ERYTHEMA
33%
Anorexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
400 mcg/m²/Dose BMN 673 QD+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/doseBMN 673 BID+55mg/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 BID+20mg/m²/Dose TEM,Max 800 mcg/Day
600 mcg/m²/Dose BMN 673 BID+20mg/m²/Dose TEM,Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+30mg/m²/Dose TEM, Max 1000 mcg/Day
600 mcg/m²/Dose BMN 673 BID+40mg/m²/Dose TEM, Max 1000 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
~2820
Avelumab
2017
Completed Phase 2
~2440

Find a Location

Who is running the clinical trial?

Georgetown UniversityLead Sponsor
346 Previous Clinical Trials
137,186 Total Patients Enrolled
33 Trials studying Breast Cancer
13,061 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,625 Previous Clinical Trials
14,284,170 Total Patients Enrolled
114 Trials studying Breast Cancer
41,447 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
~1 spots leftby Dec 2024
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