AzTrials
AzTrials

Advanced Breast CancerPhase 2NCT04892693

Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency

A Phase 2 study testing Talazoparib Oral Capsule in people with Advanced Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.

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

Talazoparib has shown clinical efficacy in breast cancer patients with germline BRCA1 or BRCA2 mutations. Beyond BRCA1 and BRCA2 mutations, it is plausible that talazoparib may have activity in patients with homologous recombination defects (HRD). Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
Talazoparib Oral Capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSouth Korea
Study dates
25 May 2021to 31 May 2027
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 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adults ≥19 years old.
  • Pathologically documented breast cancer that is unresectable or metastatic
  • Tumor with homologous recombination deficiency (HRD) defined by
  • Germline or Somatic BRCA1/2 mutation
  • Homologous recombination repair (HRR) genes mutation
  • HRD detected through RAD51 foci formation functional assay
Show all 27Show fewer
  • HRR genes: ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L
  • Previously treated with a taxane, unless this treatment was contraindicated (whether in recurrent/metastatic setting or in neoadjuvant/adjuvant setting).
  • Previous treatment with platinum therapy in the advanced or metastatic setting is permitted, provided the patient did not have a progression during the platinum treatment. If the patient was treated with neoadjuvant or adjuvant platinum therapy, at least 6 months of disease-free interval is required after the last dose.
  • Documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy).
  • If the patients had relapsed within 6 months after adjuvant therapy, this will be counted as a systemic chemotherapy for advanced or metastatic disease.
  • At least 3 weeks has passed since last chemotherapy treatment
  • At least 2 weeks has passed since last hormone therapy or radiation therapy (including palliative radiation).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
  • At least one measurable lesion that can be accurately assessed at baseline by computed tomography (CT) (magnetic resonance imaging [MRI] where CT is not feasible) and is suitable for repeated assessment as per RECIST v.1.1.
  • Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7.0 months after the last dose of study treatment.
  • This study recommend "Copper T intrauterine device" as a highly effective methods of contraception (<1% failure rate)
  • Adequate normal organ and marrow function measured within 28 days prior to administration of study treatment
  • Hemoglobin ≥9.0 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
  • Platelet count ≥ 75 x 109/L
  • Serum bilirubin ≤ 2.0mg/dL [This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.]
  • AST (SGOT)/ALT (SGPT) ≤2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be ≤5x ULN
  • Adequate renal function: Serum creatinine ≤1.5mg/dL or estimated creatinine clearance >60 mL/min
  • Negative urine pregnancy test within 7 days prior to registration in premenopausal patients.
  • Ability to understand and comply with protocol during study period
  • Patients should sign a written informed consent before study entry

Who cannot join

  • Prior treatment PARP inhibitor
  • However, if the patient participated in a clinical trial evaluating adjuvant PARP inhibitor, patient is allowed to be included in the present study if the patient recurred 6 months after completing PARP inhibitor. No more than three line of previous systemic chemotherapy, excluding neo-adjuvant and adjuvant chemotherapy. (No limitation on hormone therapy. Hormone therapy is not counted as previous line)
  • If there is a standard treatment available for metastatic breast cancer.
  • History of another primary malignancy except for
  • Malignancy treated with curative intent and with no known active disease ≥3 years
  • contralateral breast cancer
Show all 17Show fewer
  • Adequately treated non-melanoma skin cancer or lentigo malignancy without evidence of disease
  • Adequately treated carcinoma in situ without evidence of disease
  • Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled GI disease (e.g., Crohn's disease, ulcerative colitis)
  • History of leptomeningeal carcinomatosis
  • Brain metastases or spinal cord compression.
  • Patients with symptomatic uncontrolled brain metastases. A scan to confirm the absence of brain metastases is not required. The patient can receive a stable dose of corticosteroids before and during the study as long as these were started at least 4 weeks prior to treatment. Patients with spinal cord compression unless considered to have received definitive treatment for this and evidence of clinically stable disease for 28 days
  • active infection or immunocompromised patients including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), hepatitis B , hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies).
  • Subjects with simple HBV carrier, a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
  • Patients who have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study agents or their excipients.
  • Female patients who are pregnant or breastfeeding.
  • Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements.

Trial locations and contacts

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

Seock-Ah Im, MD, PhD contact

82-2-2072-0850

moisa@snu.ac.kr

Yuri Park, RN contact

82-2-3668-7088

sesame1025@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul

    Seock-Ah Im, 82-2-2072-0850, moisa@snu.ac.kr

    Kyung-Hun Lee, MD

    Recruiting

Other trials in South Korea

About this study

Official title: Talazoparib in Advanced Breast Cancer Patients With Homologous Recombinant Deficiency: A Phase II Clinical and Exploratory Biomarker Study of Talazoparib

Talazoparib has shown clinical efficacy in breast cancer patients with germline BRCA1 or BRCA2 mutations. Beyond BRCA1 and BRCA2 mutations, it is plausible that talazoparib may have activity in patients with homologous recombination defects (HRD).

Read the detailed description

BRCA 1/2 plays an essential role in homologous recombination repair and breast cancer patients with BRCA 1/2 germline mutation have homologous recombination defects (HRD). Besides BRCA1 or BRCA2 germline mutation, a proportion of breast cancer is characterized as having HRD through germline mutation, somatic mutation, and epigenetic alteration of other homologous recombination repair (HRR) genes (which includes but are not limited to ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, PPP2R2A, RAD51B, RAD51C, RAD51D, and RAD54L) (5). It is speculated that tumor with HRD may have clinical benefit from PARP inhibitor. However, the efficacy of talazoparib in advanced breast cancer with HRD is not known. The primary purpose of the present study is to evaluate the efficacy of talazoparib in breast cancer with HRD.

Being tested
Talazoparib Oral Capsule
Keywords
homologous recombinant deficiency, biomarker study of talazoparib, talazoparib, germline, BRCA

What participants receive

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

  • Talazoparib Oral CapsuleDrug

    Also called Single arm; Talazoparib

    • Patients will receive Talazoparib 1 mg orally once daily continuously, with or without food. Laboratory values will be monitored every 4 weeks until progression or unacceptable toxicity. Dose modifications should be made based on the observed toxicity
Study groups in NCT04892693
Study groupRoleWhat they receive
TalazoparibExperimental; Talazoparib should be taken orally once daily (ie, continuous daily dosing) at approximately the same time each day (preferably in the morning). Daily dosing of talazoparib can be interrupted for recovery from toxicity for up to 28 days. For interruptions longer than 28 days, treatment at the same or a reduced dose can be considered based on the discretion of the treating physician.
Receives: Drug: Talazoparib Oral Capsule

What is being measured

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

  1. Response rate (RR)

    Defined as a complete response (CR) or partial response (PR) on two consecutive assessments, at least 28 days apart, as determined by investigator assessment using RECIST v1.1

    Measured: Enrollment to end of treatment up to 2 years

Secondary outcomes (5)

  1. Progression-free survival (PFS)

    Defined as the time from the date of first dose administration to the first occurrence of disease progression, as determined by investigator assessment using RECIST v1.1, or death from any cause, whichever occurs first.

    Measured: First day of study treatment to the date of disease progression or death due to any cause, whichever came first, assessed up to 2 years

  2. Duration of objective response (DOR)

    Defined as the time from first occurrence of a documented objective response to disease progression, as determined by investigator assessment using RECIST v1.1 or death from any cause, whichever occurs first

    Measured: Enrollment to end of treatment up to 2 years

  3. Clinical benefit rate (CBR)

    Defined as having received CR or PR of any duration or stable disease (SD) ≥ 3 months per RECIST v1.1;

    Measured: Enrollment to end of treatment up to 2 years

  4. Overall survival (OS)

    Defined as the time from the date of first dose administration to death from any cause

    Measured: First day of study treatment to the date of death due to any cause, assessed up to 2 years

  5. Safety profile (Treatment-related adverse events as assessed by CTCAE v4.0)

    Number of participants with treatment-related adverse events will be assessed

    Measured: First day of study treatment to end of treatment, assessed up to 2 years

Timeline

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

  1. First posted19 May 2021
  2. Study start25 May 2021
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (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
Model description
Single arm, phase II study
Masking
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04892693
Sponsor's protocol ID
H-2009-079-1157
Status last verified
Dec 2024
First submitted
10 May 2021
Last updated
17 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Talazoparib Oral Capsule in people with Advanced Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.

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 27 inclusion and 17 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 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. 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 Seock-Ah Im, MD, PhD (82-2-2072-0850, moisa@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response rate (RR) (time frame: Enrollment to end of treatment up to 2 years). 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 NCT04892693.

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 17 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in