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.
Eligible Conditions
- Breast Cancer
- Metastatic Breast Cancer
- Hormone Receptor Positive Tumor
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: through study completion i.e up to 1 year
18 weeks
Clinical benefit response for triple negative disease subjects
24 weeks
Clinical benefit response for hormone receptor positive/ HER2 negative subjects
28 days
Rate of dose limiting toxicity
Year 1
Overall response rate
Progression free survival in all enrolled subjects
Year 1
Safety of ASTX727 plus talazoparib using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
ASTX727 + Talazoparib
1 of 1
Experimental Treatment
38 Total Participants · 1 Treatment Group
Primary Treatment: Talazoparib · No Placebo Group · Phase 1
ASTX727 + TalazoparibExperimental Group · 2 Interventions: Talazoparib, ASTX727 · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Talazoparib
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion i.e up to 1 year
Who is running the clinical trial?
Astex Pharmaceuticals, Inc.Industry Sponsor
92 Previous Clinical Trials
7,960 Total Patients Enrolled
Van Andel Institute Stand Up to Cancer TeamUNKNOWN
Kathy MillerLead Sponsor
5 Previous Clinical Trials
90 Total Patients Enrolled
1 Trials studying Metastatic Breast Cancer
18 Patients Enrolled for Metastatic Breast Cancer
PfizerIndustry Sponsor
4,308 Previous Clinical Trials
7,110,799 Total Patients Enrolled
34 Trials studying Metastatic Breast Cancer
48,481 Patients Enrolled for Metastatic Breast Cancer
Kathy Miller, MD5.018 ReviewsPrincipal Investigator - Indiana University
Cincinnati Eye Institute (Residency)
15 Previous Clinical Trials
1,152 Total Patients Enrolled
2 Trials studying Metastatic Breast Cancer
18 Patients Enrolled for Metastatic Breast Cancer
5Patient Review
They were both super friendly, professional, and personable. Cathy, the assistant, was a great help in picking out the right frames. Thank you very much!
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:The disease must be measurable or evaluable based on RECIST 1.1 criteria.
Subjects who have disease amenable to biopsy will be asked to consent to serial tumor biopsies
Subjects with no amendable disease at the time of biopsy may continue participation in the study and further study specific biopsies will not be required.
You are 18 years old or older.
Patients with hormone-positive, HER2-negative disease must have received treatment with and progressed on at least one prior endocrine therapy including a CDK4/6 inhibitor in the metastatic setting.
Patients with triple negative breast cancer must have received at least one prior chemotherapy regimen for metastatic disease.
You have locally recurrent or metastatic breast cancer.
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Conditions
Cancer Related
Treatments