Ignite Creation Date:
2024-05-06 @ 7:56 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06193525
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-11-16
Brief Title:
FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity RECAP Test
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity RECAP Test The FUTURE Trial
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FUTURE
Brief Summary:
The goal of this clinical trial is to prove that the RECAP test is capable of selecting advanced breast cancer patients sensitive for treatment with the PARP inhibitor talazoparib Participants will undergo an ultrasound-guided biopsy and a blood withdrawal Homologous Recombination HR deficient patients approximately 30 can start talazoparib treatment until progression of the disease or unacceptable side-effects and their response will be evaluated
Detailed Description:
This is a single arm prospective multicenter study among patients with advanced breast cancer with RECAP-based HRD phenotype who will be treated with talazoparib a strong PARP inhibitor After signing informed consent metastatic breast cancer patients will undergo an ultrasound or CT- guided biopsy in order to obtain at least two biopsies from a metastatic lesion to determine the HR status by the RECAP test and a blood withdrawal for ctDNA isolation HR proficient HRP patients will receive anti-tumor therapy non study drug on discretion of their treating physician only the response on treatment will be registered Approximately 30 of screened patients will have an HRD tumor and thus will be eligible to start talazoparib monotherapy until PD or unacceptable side effects The primary endpoint is PFS at four months Additional endpoints will include overall response rate and overall survival Upon progression patients will be kindly asked for consent to perform another biopsy optional and blood withdrawal in order to prove reversibility of the RECAP test outcome from HRD to HRP and explore potential mechanisms of resistance both in tissue and ctDNA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2018-002914-10 | EUDRACT_NUMBER | None | None |