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PARP Inhibitor
Talazoparib for Advanced Breast Cancer
Stanford, CA
Phase 2
Recruiting
Led By Melinda Telli
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Measurable disease per RECIST v1.115 (CT CAP with contrast and bone scan or positron emission tomography computer tomography (PET/CT) with IV contrast needed within 28 days of Cycle 1 Day 1. If patients have a history of brain metastases, a MRI brain or CT head with contrast is required
Histologically confirmed metastatic or recurrent HER2 negative breast cancer (IHC or fluorescence in situ hybridization (FISH) per ASCO/CAP guidelines)
Must not have
Prior treatment with a PARP inhibitor
Breast cancer amenable to curative treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if talazoparib is safe and effective for treating advanced breast cancer associated with a mutation in the PALB2 gene.
See full description
Who is the study for?
This trial is for adults with advanced breast cancer linked to a PALB2 gene mutation. Participants can have had up to three prior treatments, must be able to take pills, and women of childbearing age need a negative pregnancy test and use contraception. People are excluded if pregnant, breastfeeding, previously treated with PARP inhibitors, or have certain brain metastases or other conditions that could affect safety.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Talazoparib Tosylate in treating advanced breast cancer associated with PALB2 mutations. It's an oral medication given as monotherapy, meaning it's used alone without combining it with other drugs.See study design
What are the potential side effects?
While not specified here, common side effects of Talazoparib may include fatigue, blood cell count changes leading to increased infection risk or bruising/bleeding problems, nausea and vomiting, hair loss (alopecia), headache and potential kidney function issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer can be measured by scans and I've had the required scans recently.
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My breast cancer is confirmed to be HER2 negative.
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My cancer did not worsen after or during my last platinum-based treatment.
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I have had up to 3 treatments for my advanced illness.
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My kidney function is within the normal range.
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I can take care of myself and am up and about more than half of my waking hours.
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My side effects from previous cancer treatments are mild, except for hair loss and some nerve pain.
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My blood counts meet the required levels for the study.
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My cancer has a harmful PALB2 mutation confirmed by a specific test.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been treated with a PARP inhibitor before.
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My breast cancer can be treated with the aim of curing it.
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I have an active hepatitis B or C infection.
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I have not had radiation therapy in the last 14 days.
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I have not had major surgery in the last 3 weeks.
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I haven't been treated for any cancer except skin cancer or early-stage cervical/breast cancer in the last 3 years.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Objective response rate (ORR)
Secondary study objectives
Clinical Benefit Rate (CBR)
Number of participants with Treatment-related Adverse Events ≥ Grade 3
Patient-reported Quality of Life (QoL)
+1 moreSide effects data
From 2024 Phase 2 trial • 47 Patients • NCT0417350760%
Anemia
55%
Fatigue
40%
Platelet count decreased
36%
Nausea
31%
Diarrhea
31%
Weight loss
31%
White blood cell decreased
29%
Anorexia
29%
Lymphocyte count decreased
24%
Neutrophil count decreased
21%
Cough
21%
Dyspnea
21%
Pain
21%
Alkaline phosphatase increased
19%
Hypoalbuminemia
19%
Vomiting
17%
Hypokalemia
17%
Hyponatremia
14%
Constipation
14%
Peripheral sensory neuropathy
14%
Hypotension
14%
Dizziness
14%
Headache
14%
Pruritus
12%
Dehydration
12%
Pain in extremity
12%
Infusion related reaction
12%
Hypertension
12%
Hyperglycemia
10%
Dysgeusia
10%
Dry mouth
10%
Insomnia
10%
Rash maculo-papular
10%
Chills
10%
Aspartate aminotransferase increased
10%
Creatinine increased
7%
Fever
7%
Alopecia
7%
Non-cardiac chest pain
7%
Paresthesia
7%
Abdominal pain
7%
Generalized muscle weakness
7%
Pneumonitis
7%
Epistaxis
7%
Myalgia
7%
Dyspepsia
7%
Dysphagia
7%
Toothache
7%
Alanine aminotransferase increased
7%
Dry skin
5%
Respiratory failure
5%
Disease progression
2%
Metabolism and nutrition disorders-Other
2%
Superior vena cava syndrome
2%
Febrile neutropenia
2%
Atrial flutter
2%
Sinus tachycardia
2%
Fall
2%
Pneumothorax
2%
Nervous system disorders-Other
2%
Death NOS
2%
Lung infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Talazoparib Plus Avelumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Talazoparib ArmExperimental Treatment1 Intervention
Talazoparib 1 mg/day for 24 cycles (28 days per cycle), continuing until withdrawn or discontinued, eg, until RECIST 1.1 progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib Tosylate
2020
Completed Phase 2
~100
Find a Location
Closest Location:Stanford University· Stanford, CA· 1332 miles
Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,522 Previous Clinical Trials
17,427,670 Total Patients Enrolled
60 Trials studying Breast Cancer
11,808 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,705 Previous Clinical Trials
50,981,599 Total Patients Enrolled
117 Trials studying Breast Cancer
42,473 Patients Enrolled for Breast Cancer
Melinda TelliPrincipal InvestigatorStanford Universiy
1 Previous Clinical Trials
25 Total Patients Enrolled
1 Trials studying Breast Cancer
25 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer can be measured by scans and I've had the required scans recently.My liver functions are within the required limits.I am a woman who can have children, have a negative pregnancy test, and agree to more tests during the study.I can take pills by mouth.My breast cancer is confirmed to be HER2 negative.My cancer did not worsen after or during my last platinum-based treatment.I have had up to 3 treatments for my advanced illness.I have been treated with a PARP inhibitor before.I have brain metastases or leptomeningeal carcinomatosis but am stable and not on high-dose steroids.I am 18 years old or older.I have a harmful BRCA1 or BRCA2 gene mutation.You have a serious infection or bleeding disorder that could affect your ability to take part in the study safely.My kidney function is within the normal range.My breast cancer can be treated with the aim of curing it.You cannot have taken any experimental medications within 28 days before the start of the study.I can take care of myself and am up and about more than half of my waking hours.I have an active hepatitis B or C infection.I have not had radiation therapy in the last 14 days.My blood counts meet the required levels for the study.I have not had major surgery in the last 3 weeks.My side effects from previous cancer treatments are mild, except for hair loss and some nerve pain.I haven't been treated for any cancer except skin cancer or early-stage cervical/breast cancer in the last 3 years.I am willing to use birth control during and for 3 months after the study.I can provide a sample of my tumor, either recent or from a past biopsy.My cancer has a harmful PALB2 mutation confirmed by a specific test.
Research Study Groups:
This trial has the following groups:- Group 1: Talazoparib Arm
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.