TNBC - Triple-Negative Breast CancerPhase 2NCT04755868
Talazoparib Maintenance Therapy in Triple-negative Breast Cancer
A Phase 2 study testing Talazoparib in people with TNBC - Triple-Negative Breast Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The investigators propose a randomized phase II clinical trial of talazoparib maintenance therapy in TNBC patients whose tumor showed clinical benefit (platinum-sensitivity) to first- or second-line platinum-based chemotherapy (monotherapy or combination with other agents). Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- What is being tested?
- Talazoparib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2021to 1 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histologically or cytologically confirmed TNBC patients receiving first- or second-line chemotherapy for recurrent, metastatic, or unresectable disease. The triple-negative breast cancer is defined as ER negative, PR negative, and HER2 negative receptor status
- ER and PR negative defined as IHC nuclear staining < 1% AND
- HER2 negative defined as:
- IHC 0, 1+ without ISH OR
- IHC 2+ and ISH non-amplified (average HER2 gene copy number < 4 signals/cell using single-probe ISH or HER2/CEP17 ratio < 2.0 and average HER2 gene copy number < 4 signals/cell in dual-probe ISH) OR
- ISH non-amplified without IHC
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- Female patients with ≥19 years of age
- Patients on first- or second-line platinum-based (cisplatin or carboplatin) chemotherapy regimen for recurrent, metastatic, or unresectable TNBC showing platinum-sensitivity during chemotherapy
- The platinum-based chemotherapy can be either monotherapy or combination doublet chemotherapy of carboplatin or cisplatin with following combination partners: Paclitaxel, Docetaxel, Gemcitabine, Eribulin, Vinorelbine, Capecitabine, and Nab-paclitaxel.
- For the patient who recurred within 12 months after the last dose of (neo)adjuvant chemotherapy for operable stage breast cancer, the (neo)adjuvant chemotherapy will be considered as one line of chemotherapy.
- The combined targeted therapy agents including bevacizumab will be allowed but should be discontinued before randomization.
- The platinum sensitivity is determined as follows,
- Remaining stable disease after 6 tri-weekly doses or 18 weekly doses of platinum-based therapy (stable disease after 6 cycles)
- Remaining complete or partial response status after 4-6 tri-weekly doses or 12-18 weekly doses of platinum-based chemotherapy (partial or complete response after 4-6 cycles)
- Patients who can receive germline BRCA1/2 mutation test or patients with previously known germline BRCA1/2 mutation status.
- Provision of informed consent prior to any study specific procedures
- Measurable disease and/or non-measurable or no evidence of disease assessed at baseline by CT as defined by RECIST 1.1
- Patients who have received platinum as potentially curative treatment for a prior cancer (eg ovarian cancer) or as adjuvant/neoadjuvant treatment for breast cancer are eligible with at least 12 months elapsed between the last dose of curative platinum-based treatment and initiation of the platinum-based chemotherapy for recurrent, metastatic, or unresectable breast cancer.
- ECOG performance status 0 or 1
- Adequate organ function within 14 days before enrollment for treatment A. Absolute neutrophil count (ANC) ≥ 1500 cells/mm3 B. Platelets ≥ 100,000 cells/mm3 C. Hemoglobin ≥ 9.0g/dL with no blood transfusions (packed red blood cells) in the past 7 days D. Bilirubin ≤ 2.0 x ULN E. AST (SGOT) ≤ 3 x ULN (5.0 x ULN if hepatic metastases) F. ALT (SGPT) ≤ 3 x ULN (5.0 x ULN if hepatic metastases) G. Creatinine clearance ≥ 30mL/min as calculated using the Cockcroft-Gault equation or serum creatinine ≤ 1.5 ULN
- 12-Lead electrocardiogram (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
- QTc interval ≤470 msec and without history of Torsades de pointes
- Not pregnant or nursing, fertile patients must use effective contraception 2 weeks before, during, and for 7 months after completion of study treatment
- A fertile female patient whose result of the urine test or serum pregnancy test was negative within 72 hours of the first dose. If the test results are positive or not-confirmatory negative, a serum pregnancy test should be performed.
- The fertile women are required to use proper contraception (inscribed in 11.13 section) during clinical trials and up to seven months after final administration, or agree to be surgically infertile or to stop having heterosexual sex.
- The definition of infertile women is as follows, and the woman who do not fall under this category are judged to be fertile women.
- Women who have undergone infertility surgery (bilateral tubal resection, bilateral oophorectomy, or uterine resection)
- Women aged 55 or older who have no natural menstruation for more than 12 months before random assignment
- Women under the age of 55 with no natural menstruation and a menopause follicle hormone (FSH) concentration of 30 IU/L (or meet the standards of post-menopausal in the local lab) for a period of more than 12 months before randomization
- No other concurrent severe and/or uncontrolled medical disease which could compromise study participation
- Adequate treatment washout period before enrollment are below Treatment Washout Period Major surgery ≥ 4 weeks Radiation therapy ≥ 4 weeks (if palliative stereotactic radiation therapy ≥ 2 weeks)
- For patients with Germline BRCA1/2 mutations, the patients whose use of PARP inhibitors outside this clinical trial after the treatment of the platinum chemotherapy is inappropriate, impossible, or difficult to implement due to the patient's rejection, judged by the investigator or the patient for various reasons (including economic reasons)
Who cannot join
- Progression of tumor between start of platinum-based chemotherapy for recurrent, metastatic, or unresectable TNBC and randomization.
- Severe Cardiac disease (e.g., uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past year)
- Current active hepatic or biliary disease (except for Gilbert syndrome, asymptomatic gallstones, liver metastasis or stable chronic liver disease per investigator assessment).
- Any previous treatment with a PARP inhibitor, including talazoparib
- Clinically significant uncontrolled medical conditions are not permitted that would limit ability to comply with study procedures, and any other medical condition that places the patient at unacceptable risk of toxicity.
- Presence of symptomatic CNS metastases or CNS metastases that require local CNS-directed therapy (such as radiotherapy or surgery). Patients with treated brain metastases should be neurologically stable (for 4 weeks post treatment and prior to study enrollment) and without steroid therapy over physiologic dose (> 10mg prednisolone/day) for at least 2 weeks before administration of study drug.
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- Concomitant use of known potent CYP3A4/5 inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir.
- Known active hepatitis B or C infection
- Significantly altered mental status prohibiting the understanding of the study, or with psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Multiple primary malignancies within 5 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer.
- Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the study medication.
- Patients who are pregnant or nursing, or plan to be pregnant during the scheduled clinical trial period from the screening visit to 7 months after the last administration of the medication.
- Previous allogeneic bone marrow transplant.
- Patients with a known hypersensitivity to talazoparib or any of the excipients of the product.
- Patients who received live-attenuated vaccination with 30 days before the first administration of study drug
- Unresolved systemic active infection
- Patients with history of HIV infection
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University College of Medicine
Seoul, 03722
Joohyuk sohn, +82-2-2228-8135, oncosohn@yuhs.ac
About this study
Official title: A Randomized Phase II Clinical Trial of Talazoparib Maintenance Therapy in Triple-negative Breast Cancer Patients Who Showed Platinum-sensitivity on First- or Second-line Platinum-based Chemotherapy
The investigators propose a randomized phase II clinical trial of talazoparib maintenance therapy in TNBC patients whose tumor showed clinical benefit (platinum-sensitivity) to first- or second-line platinum-based chemotherapy (monotherapy or combination with other agents).
Patients are eligible when they meet at least one of two following platinum-sensitivity criteria:
Read more
- They should have received 6 tri-weekly doses or 18 weekly doses of platinum-based therapy in non-progression status (at least stable disease) at the time of enrollment;
- They should remain in complete or partial response status after 4-6 tri-weekly doses or 12-18 weekly doses of platinum-based chemotherapy. Eligible patients are enrolled to the trial within 4 to 8 weeks after last chemotherapy and 1:1 randomized to receive talazoparib versus placebo maintenance therapy.
The primary endpoint is PFS by RECIST 1.1 after randomization. The secondary endpoints include OS, time from randomization to second progression or death (PFS2), and objective response rate (ORR) by RECIST 1.1, adverse events by CTCAE 5.0 criteria, quality of life evaluated by EORTC-QLQ-C30, and EuroQoL EQ-5D.
Read the detailed description
Randomized double-blind placebo controlled phase II trial
This is a double-blind, placebo-controlled randomized phase II study, and the TNBC patients showing platinum-sensitivity after first- or second-line platinum-based chemotherapy will be screened. The total doses of platinum-based chemotherapy will be 4 or 6 doses for tri-weekly regimens and 12 or 18 doses for weekly regimen before randomization
. The platinum sensitivity is determined as follows,
- Remaining stable disease after 6 tri-weekly doses or 18 weekly doses of platinum-based therapy (stable disease after 6 cycles)
- Remaining complete or partial response status after 4-6 tri-weekly doses or 12-18 weekly doses of platinum-based chemotherapy (partial or complete response after 4-6 cycles)
The platinum sensitivity of the patients will be determined before enrollment to the clinical trial by review of central investigation institution (Yonsei Cancer Center) based on the the image reading results and, if necessary, the raw imaging data to determine that there is no tumor progression, tumor size increase, or new lesions.
The platinum-based chemotherapy can be either monotherapy or combination doublet chemotherapy of carboplatin or cisplatin with following combination partners: Paclitaxel, Docetaxel, Gemcitabine, Eribulin, Vinorelbine, Capecitabine, and Nab-paclitaxel. The combined targeted therapy agents including bevacizumab will be allowed but should be discontinued before randomization.
The patient with any BRCA1/2 mutation status is eligible. Germline BRCA1/2 test will be performed with reimbursement from South Korean health insurance in the study subject, if the subjects are under the age of 60 or have family history of BRCA-related cancers before enrollment. The testing results will be verified by the investigator. If the germline BRCA1/2 test is not covered by national health insurance (patients over 60 years of age and no family history), the BRCA1/2 germline testing will be performed with study support.
The germline BRCA mutation status will be determined before randomization if the patient do not have BRCA mutation results before. The eligible patients will be assigned to each treatment arm after 1:1 randomization. The patients will be stratified on randomization with following factors.
- 1st line platinum-based chemotherapy versus 2nd line platinum-based chemotherapy*
- Response (CR/PR vs. stable disease) to the prior platinum-based chemotherapy
- BRCA status: wild-type (including benign variants and variants of unknown significance) versus BRCA1/2-mutated (pathogenic mutation)
- For the patient who recurred within 12 months after the last dose of (neo)adjuvant chemotherapy for operable stage breast cancer, the (neo)adjuvant chemotherapy will be considered as one line of chemotherapy.
The Arm A (Experimental arm) Maintenance therapy with talazoparib (1mg once daily) (once daily 1.0 mg oral administration), 103patients The Arm B (Control arm) Maintenance therapy with placebo (once daily 1.0 mg oral administration), 103patients
The maintenance talazoparib will be initiated 4 to 8 weeks after the last dose of platinum-based chemotherapy. The talazoparib treatment will continue until disease progression by RECIST 1.1, unacceptable toxicity, or death.
Computed tomography or magnetic resonance imaging of the chest, abdomen, and pelvis will be performed at baseline, and every 8 weeks until disease progression after then.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Being tested
- Talazoparib, Placebo
- Keywords
- BRCA +, Breast cancer
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TalazoparibDrug
The Arm A (Experimental arm) Maintenance therapy with talazoparib (1mg once daily) (once daily 1.0 mg oral administration), 103patients
PlaceboDrug
The Arm B (Control arm) Maintenance therapy with placebo (once daily 1.0 mg oral administration), 103patients
| Study group | Role | What they receive |
|---|---|---|
| Maintenance therapy with talazoparib | Experimental | Maintenance therapy with talazoparib (1mg once daily) (once daily 1.0 mg oral administration), 103patients Receives: Drug: Talazoparib |
| Maintenance therapy with placebo | Active comparator | Maintenance therapy with placebo (once daily 1.0 mg oral administration), 103patients Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival (PFS) after randomization by RECIST 1.1 PFS is defined as time interval from cycle 1 day 1 to tumor progression/death/last follow-up.
Measured: 2 months
Secondary outcomes (7)
Overall survival (OS)
OS is defined as time interval from cycle 1 day 1 to tumor death/last follow-up.
Measured: 2 months
progression-free survival 2
PFS2 is defined as time interval from cycle 1 day 1 to second tumor progression or death.
Measured: 2 months
Objective response rate
ORR is defined as rate of patients with complete remission (CR) or partial remission (PR) based on RESIST1.1.
Measured: 2 months
Adverse events by CTCAE 5.0 criteria
Safety is based on CTCAE 5.0.
Measured: 2 months
Quality of life (QoL)
Quality of life (QoL) measured by EORTC-QLQ-C30
Measured: 2 months
Progression-free survival(PFS) analysis
Progression-free survival(PFS) analysis using visceral metastasis status as covariate
Measured: 2 months
Quality of life (QoL)
Quality of life (QoL) measured by EuroQoL EQ-5D
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionMar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joohyuk sohn, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755868
- Sponsor's protocol ID
- 4-2020-1131
- Status last verified
- Feb 2021
- First submitted
- 9 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Phase II Clinical Trial of Talazoparib Maintenance Therapy in Triple-negative Breast Cancer Patients Who Showed Platinum-sensitivity on First- or Second-line Platinum-based Chemotherapy
- ClinicalTrials.gov ID
- NCT04755868
- Acronym / sponsor ID
- 4-2020-1131
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Keywords
- BRCA +, Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose a randomized phase II clinical trial of talazoparib maintenance therapy in TNBC patients whose tumor showed clinical benefit (platinum-sensitivity) to first- or second-line platinum-based chemotherapy (monotherapy or combination with other agents).
Patients are eligible when they meet at least one of two following platinum-sensitivity criteria:
- They should have received 6 tri-weekly doses or 18 weekly doses of platinum-based therapy in non-progression status (at least stable disease) at the time of enrollment;
- They should remain in complete or partial response status after 4-6 tri-weekly doses or 12-18 weekly doses of platinum-based chemotherapy. Eligible patients are enrolled to the trial within 4 to 8 weeks after last chemotherapy and 1:1 randomized to receive talazoparib versus placebo maintenance therapy.
The primary endpoint is PFS by RECIST 1.1 after randomization. The secondary endpoints include OS, time from randomization to second progression or death (PFS2), and objective response rate (ORR) by RECIST 1.1, adverse events by CTCAE 5.0 criteria, quality of life evaluated by EORTC-QLQ-C30, and EuroQoL EQ-5D.
Detailed description
Randomized double-blind placebo controlled phase II trial
This is a double-blind, placebo-controlled randomized phase II study, and the TNBC patients showing platinum-sensitivity after first- or second-line platinum-based chemotherapy will be screened. The total doses of platinum-based chemotherapy will be 4 or 6 doses for tri-weekly regimens and 12 or 18 doses for weekly regimen before randomization
. The platinum sensitivity is determined as follows,
- Remaining stable disease after 6 tri-weekly doses or 18 weekly doses of platinum-based therapy (stable disease after 6 cycles)
- Remaining complete or partial response status after 4-6 tri-weekly doses or 12-18 weekly doses of platinum-based chemotherapy (partial or complete response after 4-6 cycles)
The platinum sensitivity of the patients will be determined before enrollment to the clinical trial by review of central investigation institution (Yonsei Cancer Center) based on the the image reading results and, if necessary, the raw imaging data to determine that there is no tumor progression, tumor size increase, or new lesions.
The platinum-based chemotherapy can be either monotherapy or combination doublet chemotherapy of carboplatin or cisplatin with following combination partners: Paclitaxel, Docetaxel, Gemcitabine, Eribulin, Vinorelbine, Capecitabine, and Nab-paclitaxel. The combined targeted therapy agents including bevacizumab will be allowed but should be discontinued before randomization.
The patient with any BRCA1/2 mutation status is eligible. Germline BRCA1/2 test will be performed with reimbursement from South Korean health insurance in the study subject, if the subjects are under the age of 60 or have family history of BRCA-related cancers before enrollment. The testing results will be verified by the investigator. If the germline BRCA1/2 test is not covered by national health insurance (patients over 60 years of age and no family history), the BRCA1/2 germline testing will be performed with study support.
The germline BRCA mutation status will be determined before randomization if the patient do not have BRCA mutation results before. The eligible patients will be assigned to each treatment arm after 1:1 randomization. The patients will be stratified on randomization with following factors.
- 1st line platinum-based chemotherapy versus 2nd line platinum-based chemotherapy*
- Response (CR/PR vs. stable disease) to the prior platinum-based chemotherapy
- BRCA status: wild-type (including benign variants and variants of unknown significance) versus BRCA1/2-mutated (pathogenic mutation)
- For the patient who recurred within 12 months after the last dose of (neo)adjuvant chemotherapy for operable stage breast cancer, the (neo)adjuvant chemotherapy will be considered as one line of chemotherapy.
The Arm A (Experimental arm) Maintenance therapy with talazoparib (1mg once daily) (once daily 1.0 mg oral administration), 103patients The Arm B (Control arm) Maintenance therapy with placebo (once daily 1.0 mg oral administration), 103patients
The maintenance talazoparib will be initiated 4 to 8 weeks after the last dose of platinum-based chemotherapy. The talazoparib treatment will continue until disease progression by RECIST 1.1, unacceptable toxicity, or death.
Computed tomography or magnetic resonance imaging of the chest, abdomen, and pelvis will be performed at baseline, and every 8 weeks until disease progression after then.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maintenance therapy with talazoparib | Experimental | Drug: TalazoparibMaintenance therapy with talazoparib (1mg once daily) (once daily 1.0 mg oral administration), 103patients |
| Maintenance therapy with placebo | Active comparator | Drug: PlaceboMaintenance therapy with placebo (once daily 1.0 mg oral administration), 103patients |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Histologically or cytologically confirmed TNBC patients receiving first- or second-line chemotherapy for recurrent, metastatic, or unresectable disease. The triple-negative breast cancer is defined as ER negative, PR negative, and HER2 negative receptor status
- Female patients with ≥19 years of age
- Patients on first- or second-line platinum-based (cisplatin or carboplatin) chemotherapy regimen for recurrent, metastatic, or unresectable TNBC showing platinum-sensitivity during chemotherapy
- The platinum sensitivity is determined as follows,
- Patients who can receive germline BRCA1/2 mutation test or patients with previously known germline BRCA1/2 mutation status.
Key exclusion criteria (17 listed)
- Progression of tumor between start of platinum-based chemotherapy for recurrent, metastatic, or unresectable TNBC and randomization.
- Severe Cardiac disease (e.g., uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past year)
- Current active hepatic or biliary disease (except for Gilbert syndrome, asymptomatic gallstones, liver metastasis or stable chronic liver disease per investigator assessment).
- Any previous treatment with a PARP inhibitor, including talazoparib
- Clinically significant uncontrolled medical conditions are not permitted that would limit ability to comply with study procedures, and any other medical condition that places the patient at unacceptable risk of toxicity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TalazoparibThe Arm A (Experimental arm) Maintenance therapy with talazoparib (1mg once daily) (once daily 1.0 mg oral administration), 103patients | Drug | Maintenance therapy with talazoparib |
| PlaceboThe Arm B (Control arm) Maintenance therapy with placebo (once daily 1.0 mg oral administration), 103patients | Drug | Maintenance therapy with placebo |
Primary outcome
Progression-free survival
Time frame: 2 months
Progression-free survival (PFS) after randomization by RECIST 1.1 PFS is defined as time interval from cycle 1 day 1 to tumor progression/death/last follow-up.
7 secondary outcomes
Overall survival (OS)
Time frame: 2 months
progression-free survival 2
Time frame: 2 months
Objective response rate
Time frame: 2 months
Adverse events by CTCAE 5.0 criteria
Time frame: 2 months
Quality of life (QoL)
Time frame: 2 months
Progression-free survival(PFS) analysis
Time frame: 2 months
Quality of life (QoL)
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joohyuk sohn principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Talazoparib in people with TNBC - Triple-Negative Breast Cancer, run by Yonsei University 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 32 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joohyuk sohn (+82-2-2228-8135, oncosohn@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2021.