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Nucleoside Analog
ASTX727 + Talazoparib for Breast Cancer
Phase 1
Waitlist Available
Led By Kathy Miller, MD
Research Sponsored by Kathy Miller
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with triple negative breast cancer must have received at least one prior chemotherapy regimen for metastatic disease
Adequate organ function as indicated by: Total bilirubin </= ULN (upper limit of normal) (except in patients with documented Gilbert's disease, who must have a total bilirubin </= 3.0 mg/dL), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 3.0 x ULN (</= 1.5-3.0 x baseline if baseline is abnormal), Calculated creatinine clearance of >/= 60 mL/min using the Cockcroft-Gault formula, Absolute neutrophil count (ANC) >/= 1.5 K/mm3, Platelets >/= 100 K/mm3, Hemoglobin (Hgb) >/= 9.0 g/dL
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion i.e up to 1 year
Awards & highlights
Study Summary
This trial is testing a new cancer treatment to see if it is safe for patients with triple negative breast cancer or hormone resistant/HER2-negative metastatic breast cancer.
Who is the study for?
This trial is for adults with triple negative or hormone resistant/HER2-negative metastatic breast cancer. Participants must have had prior chemotherapy, be in good physical condition, and women of childbearing age must test negative for pregnancy and agree to use contraception. People with active brain metastases or those treated with certain drugs are excluded.Check my eligibility
What is being tested?
The study is testing the safety of combining two drugs: ASTX727 and talazoparib. It's a Phase I trial focusing on patients who've previously undergone at least one chemotherapy regimen for metastatic disease or hormone therapy including a CDK4/6 inhibitor.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar treatments include nausea, fatigue, blood cell count changes, potential allergic reactions, and organ-specific issues like liver function alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have triple negative breast cancer and have had chemotherapy for it after it spread.
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My liver and kidney functions are normal, and my blood counts are within healthy ranges.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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My cancer is hormone-positive, HER2-negative, and has worsened despite treatment with an endocrine therapy and a CDK4/6 inhibitor.
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My breast cancer has returned or spread and cannot be cured with surgery or radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion i.e up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion i.e up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of dose limiting toxicity
Safety of ASTX727 plus talazoparib using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0
Secondary outcome measures
Clinical benefit response for hormone receptor positive/ HER2 negative subjects
Clinical benefit response for triple negative disease subjects
Overall response rate
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: ASTX727 + TalazoparibExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
FDA approved
ASTX727
2018
Completed Phase 3
~240
Find a Location
Who is running the clinical trial?
PfizerIndustry Sponsor
4,575 Previous Clinical Trials
10,923,067 Total Patients Enrolled
112 Trials studying Breast Cancer
35,865 Patients Enrolled for Breast Cancer
Astex Pharmaceuticals, Inc.Industry Sponsor
95 Previous Clinical Trials
7,927 Total Patients Enrolled
1 Trials studying Breast Cancer
Van Andel Institute Stand Up to Cancer TeamUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had brain treatment over 4 weeks ago, feel stable, and am on a steady or reducing steroid dose.I haven't had chemotherapy in the last 3 weeks.I have triple negative breast cancer and have had chemotherapy for it after it spread.My cancer can be biopsied, but I understand it's optional for this trial.I have not started hormone therapy in the last 2 weeks.Your disease can be measured or evaluated according to specific criteria called RECIST 1.1.My liver and kidney functions are normal, and my blood counts are within healthy ranges.My cancer is HER2 positive.I have been treated with specific DNA-targeting drugs before.I have breast cancer and no other active cancers.I have active or symptomatic brain or spinal cord problems.I am 18 years old or older.I have not had radiation therapy in the last 2 weeks.I need continuous treatment with strong P-gp inhibitors.I am fully active or can carry out light work.I have previously been treated with a PARP inhibitor.My cancer is hormone-positive, HER2-negative, and has worsened despite treatment with an endocrine therapy and a CDK4/6 inhibitor.My breast cancer has returned or spread and cannot be cured with surgery or radiation.I have a harmful BRCA gene mutation or haven't been tested yet.
Research Study Groups:
This trial has the following groups:- Group 1: ASTX727 + Talazoparib
Awards:
This trial has 3 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Is Talazoparib hazardous for individuals to use?
"Due to the limited efficacy and safety data available, Talazoparib was assigned a score of 1 on our team's scale. This is reflective of its Phase 1 status."
Answered by AI
Is recruitment currently running for this clinical research?
"Indeed, the information available on clinicaltrials.gov implies that recruitment for this study is still taking place. The project was first posted in March of 2020 and its most recent update occurred on September 23rd 2022. They are currently seeking 38 participants from two medical centres."
Answered by AI
Are there extant studies examining the efficacy of Talazoparib?
"Initially researched at City of Hope in 2010, talazoparib has since been studied 23 times. Currently 58 studies are actively recruiting participants, predominately from Winston-Salem, North carolina."
Answered by AI
How many participants have been enlisted in this clinical experiment?
"Affirmative, clinicaltrials.gov's records indicate that this study is currently seeking volunteer participants. The trial was first launched on March 30th 2020 and recently revised on September 23rd 2022. There are 38 prospective candidates to be found at two different medical facilities."
Answered by AI
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