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Advanced Breast CancerPhase 2FUTURENCT06193525

FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test

A Phase 2 study testing Talazoparib in people with Advanced Breast Cancer, run by Erasmus Medical Center at 3 sites in Netherlands.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Breast Cancer
What is being tested?
Talazoparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
3 sitesNetherlands
Study dates
16 Sep 2019to Dec 2025
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • WHO performance status 0-2
  • Locally advanced breast cancer without options for treatment with curative intent or metastatic breast cancer
  • Objective progressive disease (PD) according to RECIST within 4 months prior to study entry
  • The breast cancer must be either
  • high grade (Bloom \& Richardson grade 3) ER positive (>10%) and HER2 negative primary breast cancer, or
  • triple negative (ER<10%, PR<10% and HER2 negative), or
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  • any Bloom \& Richardson grading and receptor status and also
  • at least one metastatic lesion must have a proven HRD phenotype based on a RECAP test not treated with anticancer therapy thereafter or
  • the patient must have a proven germline or somatic BRCA1 and/or BRCA2 mutation The Bloom \& Richardson grading is always based on the primary tumor. The receptor status can be based on the primary tumor or a metastatic lesion whichever comes latest.
  • The site of the metastatic lesion (or primary tumor in case it is still in situ) should be easily amendable for biopsy. NB lung metastases (high risk of hemato/pneumo-thorax) and bone metastases (not suitable for RECAP test because calcifications interfere with experimental procedures) are excluded. The local guidelines will be used for stopping and r estarting of anticoagulation. Bilirubin <1.5 ULN (except elevated bilirubin due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin) and both AST and ALT <5x ULN in case a liver biopsy is planned.
  • The tumor must be HRD, defined as HRD identified by the RECAP test determined just before the start of potential Talazoparib treatment within this study (also in case a proven germline BRCA1/2 mutation is present).
  • Maximum of four prior lines of chemotherapy for advanced disease; Patients who received platinum compounds are eligible if they have had at least a progression free interval of four months.
  • Measurable or evaluable disease according to RECIST 1.1 criteria (appendix 2)
  • Life expectancy ≥ 3 months
  • Hemoglobin ≥ 10 g/dL (6,2 mmol/L) and ANC of ≥ 1.5 x 109 /L
  • Platelets >100 x 10e9/L
  • Hepatic function as defined by total serum bilirubin ≤ 1. 5 x ULN (except elevated bilirubin due to Gilbert's disease or a similar syndrome involving slow conjugation of bilirubin), ASAT and ALAT < 3 x ULN or <5 x ULN in case of liver metastasis
  • Adequate renal function as defined by either serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min (by Cockcroft-Gault formula)
  • Negative pregnancy test (urine/serum) for female patients with childbearing potential
  • Written informed consent

Who cannot join

  • Any psychological condition potentially hampering compliance with the study protocol
  • Any treatment with investigational antitumor drugs within 28 days prior to receiving the first dose of investigational treatment; or within 21 days for standard chemotherapy; or within 14 days for weekly scheduled chemotherapeutic regimens or endocrine therapy
  • Radiotherapy within the last four weeks prior to receiving the first dose of investigational treatment; except 1 or 2 x 8 Gy for pain palliation, then seven days interval after the last radiation should be maintained
  • Known persistent (>4 weeks) ≥ Grade 2 toxicity from prior cancer therapy (except for alopecia grade 2)
  • Symptomatic brain or leptomeningeal metastases. Patients completely free of symptoms and without corticosteroids for at least four weeks after adequate treatment by resection and/or irradiation could be eligible (consult PI).
  • Women who have a positive pregnancy test (urine/serum) and/or who are breastfeeding
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  • Unreliable contraceptive methods. Women and men enrolled in this trial must agree to use a reliable contraceptive method throughout the study (adequate contraceptive methods are: intra-uterine devices or systems, condom or other barrier contraceptive measures, sterilization and true abstinence)
  • Concomitant use of P-gp inhibitors or inducers or BCRP inhibitors (see Appendix A)
  • Any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
  • Uncontrolled infectious disease (such as Human Immunodeficiency Virus HIV-1 or HIV-2 infection) or known active hepatitis B or C
  • Recent myocardial infarction (< six months) or unstable angina

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clinical Trial Center contact

0031107041566

secretariaatctc@erasmusmc.nl

Netherlands3 sites, 3 recruiting

  • Groningen University Medical Center

    Groningen, 9713GZ

    Clinical Trial Center, +31107041566, secretariaatctc@erasmusmc.nl

    M Jalving, MD, PhD, +31503616161, m.jalving@umcg.nl

    Recruiting

  • Leiden University Medical Center

    Leiden, South Holland, 2333ZA

    Clinical Trial Center, +31107041566, secretariaatctc@erasmusmc.nl

    J R Kroep, MD, PhD, +31715263523, j.r.kroep@lumc.nl

    Recruiting

  • Erasmus Medical Center

    Rotterdam, South Holland, 3015GD

    Clinical Trial Center, +31107041566, secretariaatctc@erasmusmc.nl

    Agnes Jager, MD, PhD

    Recruiting

Other trials in Netherlands

About this study

Official title: FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test: The FUTURE Trial

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.

Read the 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).

Being tested
Talazoparib
Keywords
Metastatic Breast Cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TalazoparibDrug

    Also called Talazoparib 1 MG Oral Capsule [Talzenna]

    Talazoparib is administered daily as single agent, 1 mg orally until unacceptable toxicity or progression of disease.

Study groups in NCT06193525
Study groupRoleWhat they receive
TalazoparibExperimentalTalazoparib Capsule, oral use 1 mg per day until PD or unacceptable toxicity
Receives: Drug: Talazoparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients with PFS at 4 months

    The percentage of patients with advanced HRD breast cancer with PFS of 4 months or longer on talazoparib monotherapy. Disease assessment is performed by CT chest-abdomen per RECIST v 1.1.

    Measured: Baseline. During the intervention: every 2 cycles (each cycle is 28 days), preferably within 7 days before the start of every uneven cycle. Follow-up until PD, unacceptable toxicity or death. Until all patients have reached PFS endpoint (end of study).

Secondary outcomes (2)

  1. Overall response rate (ORR)

    The proportion of patients whose confirmed best overall response is either a PR or CR based upon investigator assessment per standard RECIST v1.1. Disease assessment is performed by CT chest-abdomen.

    Measured: Baseline. During the intervention: every 2 cycles (each cycle is 28 days), preferably within 7 days before the start of every uneven cycle. Follow-up until PD, unacceptable toxicity or death. Until all patients have reached PFS endpoint (end of study).

  2. Overall survival (OS)

    OS of patients with advanced HRD breast cancer treated with talazoparib

    Measured: Time from first administration of talazoparib to time of death due to any cause. Follow-up on survival at least every 3 months for year 1, every 6 months for year 2 and 3 and annually until death. Until all patients have reached PFS (end of study).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start16 Sep 2019
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06193525
Sponsor's protocol ID
MEC 19-0070
Other IDs
2018-002914-10, 2018
Acronym
FUTURE
Status last verified
Feb 2025
First submitted
16 Nov 2023
Last updated
28 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Talazoparib in people with Advanced Breast Cancer, run by Erasmus Medical Center at 3 sites in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trial Center (0031107041566, secretariaatctc@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with PFS at 4 months (time frame: Baseline. During the intervention: every 2 cycles (each cycle is 28 days), preferably within 7 days before the start of every uneven cycle. Follow-up until PD, unacceptable toxicity or death. Until all patients have reached PFS endpoint (end of study).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06193525.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.

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