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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 treated, asymptomatic central nervous system (CNS) disease may participate if the patient is > 4 weeks from completion of CNS therapy (radiation and/or surgery), is clinically stable at the time of study entry, and is receiving a stable or decreasing dose of corticosteroid therapy. Brain MRI or head CT is required at screening for patients with known brain metastases
Patients with triple negative breast cancer must have received at least one prior chemotherapy regimen for metastatic disease
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 below
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I had brain treatment over 4 weeks ago, feel stable, and am on a steady or reducing steroid dose.
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I have triple negative breast cancer and have had chemotherapy for it after it spread.
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My cancer can be biopsied, but I understand it's optional for this trial.
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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 weeks
Treatment ~ Varies
Follow Up ~through study completion i.e up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion i.e up to 1 year for reporting.

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 more

Trial 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
4,566 Previous Clinical Trials
10,908,091 Total Patients Enrolled
111 Trials studying Breast Cancer
36,404 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

ASTX727 (Nucleoside Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04134884 — Phase 1
Breast Cancer Research Study Groups: ASTX727 + Talazoparib
Breast Cancer Clinical Trial 2023: ASTX727 Highlights & Side Effects. Trial Name: NCT04134884 — Phase 1
ASTX727 (Nucleoside Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04134884 — Phase 1

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
~7 spots leftby Apr 2025