Breast CancerPhase 2NCT04756765
Talazoparib Monotherapy in PALB2 Mutation Associated Advanced Breast Cancer
A Phase 2 study testing Talazoparib Tosylate in people with Breast Cancer and Advanced Breast Cancer, run by Stanford University at 1 site in United States.
Trial summary
This purpose of this study is to test if talazoparib is safe and evaluate its response to advanced breast cancer associated with mutation of gene called PALB. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Advanced Breast Cancer
- What is being tested?
- Talazoparib Tosylate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2023to 18 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed metastatic or recurrent HER2 negative breast cancer (IHC or fluorescence in situ hybridization (FISH) per ASCO/CAP guidelines).
- Deleterious or suspected deleterious mutation in PALB2 assessed by Clinical Laboratory Improvement Amendments (CLIA) approved tumor next generation sequencing (NGS) or germline assay.
- Women and men ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- All clinically significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v 5.0), except alopecia and G2 neuropathy.
- Measurable disease per RECIST v1.115 (CT CAP with contrast and bone scan or positron emission tomography computer tomography (PET/CT) with IV contrast needed within 28 days of Cycle 1 Day 1. If patients have a history of brain metastases, a MRI brain or CT head with contrast is required).
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- A minimum 21 day wash out from previous treatment is required.
- No evidence of progression on platinum (e.g., carboplatin or cisplatin) or within 8 weeks of last platinum dose
- Adequate hematologic function
- Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3)
- Hemoglobin ≥ 9.0 g/dL with last transfusion at least 14 days before Day 1 of study drug
- Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3)
- Adequate hepatic function
- Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN.
- Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN; if liver function abnormalities are due to hepatic metastasis, then AST and ALT ≤ 5 x ULN
- Adequate renal function
- Serum creatinine ≤ 1.5 x ULN; or
- Calculated creatinine clearance > 50 mL/min using the Cockcroft Gault formula.
- Able to take oral medications
- Received 0 3 prior therapies for advanced disease
- Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test and be willing to have additional urine pregnancy tests during the study. Women considered not of childbearing potential include those who have had no menstrual period for at least 1 year and have an estradiol in the postmenopausal range, or had tubal ligation at least 1 year prior to screening, or who have had total hysterectomy or bilateral oophorectomy.
- WOCBP must agree to use effective contraception as of C1D1 and for 3 months after the last dose.
- Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.
- Willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research related procedures
- Willing and able to comply with all study procedures
- Adequate archival or fresh tumor sample from metastatic biopsy site; archival tumor from the primary breast tumor may be submitted if metastatic biopsy is not available and/or infeasible
Who cannot join
- Breast cancer amenable to curative treatment.
- Prior treatment with a PARP inhibitor.
- Deleterious or suspected deleterious germline or somatic BRCA1 or BRCA2 gene mutation. Patients with variants of unknown significance will be eligible.
- Active Brain metastases OR leptomeningeal carcinomatosis. EXCEPTION: Adequately treated brain metastases documented by baseline CT or MRI scan that have not progressed since previous scans and do not require corticosteroids (prednisone 5 mg/day or equivalent allowed) for management of central nervous system (CNS) symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.
- Pregnant or breastfeeding patients.
- Other malignancy that is either active or for which patient has received treatment in the last three years excluding non melanoma skin cancer and carcinoma in situ of the cervix or breast.
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- Known active hepatitis B or hepatitis C.
- Investigational agents within 28 days of C1D1.
- Radiation therapy within 14 days of C1D1.
- Major surgery within 21 days of C1D1.
- Concurrent disease or condition that would interfere with study participation or safety, such as any of the following:
- Active, clinically significant infection either grade > 2 by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 or requiring the use of parenteral anti microbial agents within 7 days of C1D1.
- Clinically significant bleeding diathesis or coagulopathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Clinical Trial of Talazoparib Monotherapy for PALB2 Mutation Associated Advanced Breast Cancer
This purpose of this study is to test if talazoparib is safe and evaluate its response to advanced breast cancer associated with mutation of gene called PALB.
Read the detailed description
Primary Objectives: To evaluate whether talazoparib monotherapy can induce a 30% rate of objective response in subjects with advanced breast cancer associated with a PALB2 mutation.
Secondary Objective(s)
- To evaluate the safety of talazoparib in subjects with advanced PALB2 mutation associated breast cancer
- To evaluate the progression free survival (PFS) of talazoparib monotherapy in subjects with advanced PALB2 mutation associated breast cancer
- To evaluate the clinical benefit rate (CBR) of talazoparib monotherapy in subjects with advanced PALB2 mutation associated breast cancer
- To evaluate the ability of circulating tumor DNA (ctDNA) to identify and characterize the nature of PALB2 mutations at baseline and upon progression in subjects with advanced PALB2 mutation associated breast cancer treated with talazoparib monotherapy
- To evaluate patient reported quality of life on talazoparib monotherapy
- Conditions
- Breast Cancer, Advanced Breast Cancer
- Being tested
- Talazoparib Tosylate
- Keywords
- PALB2 mutation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Talazoparib TosylateDrug
Also called Talzenna, BMN-673
Talazoparib1 mg/day is to be administered orally on a continuous dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| Talazoparib Arm | Experimental | Talazoparib 1 mg/day for 24 cycles (28 days per cycle), continuing until withdrawn or discontinued, eg, until RECIST 1.1 progression or unacceptable toxicity. Receives: Drug: Talazoparib Tosylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Response to treatment will be assessed as the number and proportion of participants who achieve either a confirmed complete response (CR) or partial response (PR). The outcome is reported as numbers without dispersion. Clinical response will be assessed as follows.
CR: Complete disappearance of all clinical evidence of disease PR: Decrease in size or amount of measurable disease lesions Progressive disease (PD): Worsening of lesions; appearance of new lesions; or recurrence of lesions Stable disease (SD): Disease status that is neither CR, PR, nor PD.
Measured: 8 weeks +/-1 week
Secondary outcomes (4)
Clinical Benefit Rate (CBR)
Clinical benefit rate (CBR) will be reported as the number and proportion of participants who achieve CR, PR or Stable Disease (SD) 6 months. The outcome is reported as numbers without dispersion.
Measured: 8 weeks +/- 1 week
Progression-free survival (PFS)
Median progression free survival (PFS) will be assessed as the period of survival from therapy initiation without the development of progressive disease per RECIST 1.1. The outcome is reported as a number without dispersion.
Measured: 8 weeks +/- 1 week
Patient-reported Quality of Life (QoL)
Change from Baseline in Global Health Status/Quality of Life (QoL) Measured by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30) EORTC QLQ C30 has 30 questions. First 28 questions evaluate 5 functional scales and 3 symptom scales and other single items. Each question assessed on 4 point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much); functional scales: higher score = better level of functioning; symptom scale: higher score = more severe symptoms; for single items: higher score= more severe problem. Last 2 questions evaluate global health status (GHS)/QoL. Each question is assessed on 7 point scale (1=very poor to 7=excellent). Scores averaged, transformed to 0-100 scale; higher score means a better quality of life/better level of functioning. The outcome will be reported as the median QoL score with standard deviation.
Measured: 8 weeks +/- 1 week
Number of participants with Treatment-related Adverse Events ≥ Grade 3
Toxicity will be assessed as adverse events that are severe or greater (≥ Grade 3), and possibly, probably, or definitely related to talazoparib. The outcome will be reported as the total number of qualifying events, a number without dispersion.
Measured: 3 years
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 start23 Feb 2023
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Why it stopped: Due to changes in the treatment landscape, the study faced significant recruitment challenges. As no patients were enrolled, the sponsor requested study closure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Melinda Telli, Principal investigator, Stanford Universiy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756765
- Sponsor's protocol ID
- IRB-59141
- Other IDs
- BRS0126, NCI-2023-01961
- Status last verified
- Aug 2025
- First submitted
- 11 Feb 2021
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Clinical Trial of Talazoparib Monotherapy for PALB2 Mutation Associated Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04756765
- Acronym / sponsor ID
- IRB-59141
- Conditions
- Breast Cancer, Advanced Breast Cancer
- Keywords
- PALB2 mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to changes in the treatment landscape, the study faced significant recruitment challenges. As no patients were enrolled, the sponsor requested study closure
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 23 Feb 2023 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- 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.
This purpose of this study is to test if talazoparib is safe and evaluate its response to advanced breast cancer associated with mutation of gene called PALB.
Detailed description
Primary Objectives: To evaluate whether talazoparib monotherapy can induce a 30% rate of objective response in subjects with advanced breast cancer associated with a PALB2 mutation.
Secondary Objective(s)
- To evaluate the safety of talazoparib in subjects with advanced PALB2 mutation associated breast cancer
- To evaluate the progression free survival (PFS) of talazoparib monotherapy in subjects with advanced PALB2 mutation associated breast cancer
- To evaluate the clinical benefit rate (CBR) of talazoparib monotherapy in subjects with advanced PALB2 mutation associated breast cancer
- To evaluate the ability of circulating tumor DNA (ctDNA) to identify and characterize the nature of PALB2 mutations at baseline and upon progression in subjects with advanced PALB2 mutation associated breast cancer treated with talazoparib monotherapy
- To evaluate patient reported quality of life on talazoparib monotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Talazoparib Arm | Experimental | Drug: Talazoparib TosylateTalazoparib 1 mg/day for 24 cycles (28 days per cycle), continuing until withdrawn or discontinued, eg, until RECIST 1.1 progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Histologically confirmed metastatic or recurrent HER2 negative breast cancer (IHC or fluorescence in situ hybridization (FISH) per ASCO/CAP guidelines).
- Deleterious or suspected deleterious mutation in PALB2 assessed by Clinical Laboratory Improvement Amendments (CLIA) approved tumor next generation sequencing (NGS) or germline assay.
- Women and men ≥ 18 years of age.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- All clinically significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v 5.0), except alopecia and G2 neuropathy.
Key exclusion criteria (13 listed)
- Breast cancer amenable to curative treatment.
- Prior treatment with a PARP inhibitor.
- Deleterious or suspected deleterious germline or somatic BRCA1 or BRCA2 gene mutation. Patients with variants of unknown significance will be eligible.
- Active Brain metastases OR leptomeningeal carcinomatosis. EXCEPTION: Adequately treated brain metastases documented by baseline CT or MRI scan that have not progressed since previous scans and do not require corticosteroids (prednisone 5 mg/day or equivalent allowed) for management of central nervous system (CNS) symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.
- Pregnant or breastfeeding patients.
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 |
|---|---|---|
| Talazoparib TosylateAlso: Talzenna, BMN-673Talazoparib1 mg/day is to be administered orally on a continuous dosing schedule. | Drug | Talazoparib Arm |
Primary outcome
Objective response rate (ORR)
Time frame: 8 weeks +/-1 week
Response to treatment will be assessed as the number and proportion of participants who achieve either a confirmed complete response (CR) or partial response (PR). The outcome is reported as numbers without dispersion. Clinical response will be assessed as follows. CR: Complete disappearance of all clinical evidence of disease PR: Decrease in size or amount of measurable disease lesions Progressive disease (PD): Worsening of lesions; appearance of new lesions; or recurrence of lesions Stable disease (SD): Disease status that is neither CR, PR, nor PD.
4 secondary outcomes
Clinical Benefit Rate (CBR)
Time frame: 8 weeks +/- 1 week
Progression-free survival (PFS)
Time frame: 8 weeks +/- 1 week
Patient-reported Quality of Life (QoL)
Time frame: 8 weeks +/- 1 week
Number of participants with Treatment-related Adverse Events ≥ Grade 3
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- 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.
Melinda Telli principal investigator
Stanford Universiy
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 Tosylate in people with Breast Cancer and Advanced Breast Cancer, run by Stanford University at 1 site in United States.
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 26 inclusion and 13 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: withdrawn, as of the sponsor's last update on 17 Aug 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 8 weeks +/-1 week). 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 17 Aug 2025.