Summary
Talazoparib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Breast Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Breast Cancer. ClinicalTrials.gov lists 8 registered trials linking Talazoparib to Breast Cancer: 1 is currently recruiting; 2 are active or not yet recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT04591431). It plans or enrolled 400 participants. Registration activity spans 2015 to 2025. The literature layer holds 20 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 1 systematic review, 5 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2020 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Breast Cancer ranks 1462 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression documented but rare (<0.5%); 5-year survival stage I: ~99%; stage IV: ~28% overall, improving with modern therapy.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 70.0 (trials 20.0, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 2 active / not yet recruiting, 3 completed, 2 other |
| Linked publications | 20 (5 Cochrane reviews, 5 clinical trial publications, 5 randomised controlled trial publications, 4 meta-analyses, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | BRCA1 |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT04591431 | The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy 2020 | status unknown | Phase 2 | 400 |
| NCT04703920 | Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer 2021 | completed | Phase 1 | 26 |
| NCT02358200 | Study of BMN-673 With Carboplatin and Paclitaxel in Patients With Advanced BRCA-mutated Solid Tumor or Triple Negative Metastatic Breast Cancer 2015 | terminated | Phase 1 | 23 |
| NCT03964532 | TALAVE: Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer 2019 | active, not recruiting | PHASE1, PHASE2 | 24 |
| NCT06735742 | A Study to Learn About the Safety of TALZENNA for the Treatment of Breast Cancer 2025 | active, not recruiting | Not applicable | 3 |
| NCT04987931 | Real-World Outcomes of US Talazoparib-Treated Patients With Locally Advanced or Metastatic Breast Cancer 2021 | completed | Not applicable | 84 |
| NCT05141708 | Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m 2021 | completed | Not applicable | 33 |
| NCT05035745 | Selinexor & Talazoparib in Advanced Refractory Solid Tumors; Advanced/Metastatic Triple Negative Breast Cancer (START) 2021 | recruiting | PHASE1, PHASE2 | 63 |
Published literature
- Clinical trial publication A phase 1 study of ASTX727 plus talazoparib in patients with triple-negative or hormone resistant/HER2-negative metastatic breast cancerMiller KD, Thomas A, Althouse S et al. · Cancer · 2026 · PMID 41980055
- Clinical trial publication Resistance to neoadjuvant talazoparib in triple-negative breast cancer by BRN2-induced ATR/STAT3 pathways or SHLD2 subclone expansionAbdulkareem NM, Jiang Y, Qi Y et al. · Proceedings of the National Academy of Sciences of the United States of America · 2026 · PMID 41961819
- Clinical trial publication Phase I/II trial investigating gedatolisib plus talazoparib in advanced triple negative or BRCA1/2 positive, HER2 negative breast cancersPhadke S, Miller KD, Shah A et al. · Breast cancer research and treatment · 2025 · PMID 40471518
- Meta-analysis Neurological toxicities with poly (ADP-ribose) polymerase inhibitors in cancer patients: a systematic review and meta-analysisJin W, Zhang Z, Sun W et al. · Journal of chemotherapy (Florence, Italy) · 2025 · PMID 39180239
- Clinical trial publication Cost-effectiveness of talazoparib for patients with germline BRCA1/2 mutated HER2-negative advanced breast cancer in China and the USPan J, Ren N, Ren L et al. · Scientific reports · 2024 · PMID 38886516
- Clinical trial publication Neoadjuvant talazoparib in patients with germline BRCA1/2 mutation-positive, early-stage triple-negative breast cancer: exploration of tumor BRCA mutational statusTelli ML, Litton JK, Beck JT et al. · Breast cancer (Tokyo, Japan) · 2024 · PMID 38869771
- Cochrane review Efficacy and safety of first-line treatment for metastatic triple-negative breast cancer: A network meta-analysisShi M, Li Z, Shen G et al. · Cancer pathogenesis and therapy · 2024 · PMID 38601487
- Meta-analysis Poly (ADP-ribose) Polymerase Inhibitors Have Comparable Efficacy with Platinum Chemotherapy in Patients with BRCA-positive Metastatic Castration-resistant Prostate Cancer. A Systematic Review and Meta-analysisFazekas T, Széles ÁD, Teutsch B et al. · European urology oncology · 2024 · PMID 37722977
- Systematic review Targeted Treatment of Metastatic Triple-Negative Breast Cancer: A Systematic ReviewHammershøi Madsen AM, Løvendahl Eefsen RH, Nielsen D et al. · The breast journal · 2024 · PMID 39742383
- Cochrane review PARP Inhibitors for the Treatment of BRCA1/2-Mutated Metastatic Breast Cancer: A Systematic Review and Meta-analysisKunwor R, Silver DP, Abu-Khalaf M · Hematology/oncology and stem cell therapy · 2023 · PMID 37023220
- Cochrane review Comparative Efficacy and safety of new targeted therapies and immunotherapies for metastatic triple negative breast cancer: a network meta-analysisLeung JH, Tai YS, Wang SY et al. · Expert opinion on drug safety · 2023 · PMID 35998294
- Cochrane review Cost-effectiveness of PARP inhibitors in malignancies: A systematic reviewDing H, He C, Tong Y et al. · PloS one · 2022 · PMID 36520958
- Cochrane review Economic and Humanistic Burden of Triple-Negative Breast Cancer: A Systematic Literature ReviewHuang M, Haiderali A, Fox GE et al. · PharmacoEconomics · 2022 · PMID 35112331
- Meta-analysis PARP-inhibitors for BRCA1/2-related advanced HER2-negative breast cancer: A meta-analysis and GRADE recommendations by the Italian Association of Medical OncologyMiglietta F, Cinquini M, Dieci MV et al. · Breast (Edinburgh, Scotland) · 2022 · PMID 36379199
- Meta-analysis Multiple Bayesian network meta-analyses to establish therapeutic algorithms for metastatic triple negative breast cancerSchettini F, Venturini S, Giuliano M et al. · Cancer treatment reviews · 2022 · PMID 36202026
- Randomized controlled trial Cost-effectiveness of talazoparib for patients with locally advanced or metastasized breast cancer in GermanySchwarz F, Arefian H, Hartmann M et al. · PloS one · 2022 · PMID 36454738
- Randomized controlled trial PARP Inhibitor in Platinum-Resistant Ovarian Cancer: Single-Center Real-World ExperienceAgarwal A, Baghmar S, Dodagoudar C et al. · JCO global oncology · 2021 · PMID 33852339
- Randomized controlled trial Talazoparib Versus Chemotherapy in Patients with HER2-negative Advanced Breast Cancer and a Germline BRCA1/2 Mutation Enrolled in Asian Countries: Exploratory Subgroup Analysis of the Phase III EMBRACA TrialLee KH, Sohn J, Goodwin A et al. · Cancer research and treatment · 2021 · PMID 33781053
- Randomized controlled trial Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trialLitton JK, Hurvitz SA, Mina LA et al. · Annals of oncology : official journal of the European Society for Medical Oncology · 2020 · PMID 32828825
- Randomized controlled trial Exposure-Safety Analyses of Talazoparib in Patients With Advanced Breast Cancer and Germline BRCA1/2 Mutations in the EMBRACA and ABRAZO TrialsElmeliegy M, Yu Y, Litton JK et al. · Journal of clinical pharmacology · 2020 · PMID 32468645
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Talazoparib approved for Breast Cancer?
Talazoparib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Breast Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Breast Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Talazoparib in clinical trials for Breast Cancer?
ClinicalTrials.gov lists 8 registered trials linking Talazoparib to Breast Cancer: 1 is currently recruiting; 2 are active or not yet recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT04591431). It plans or enrolled 400 participants. Registration activity spans 2015 to 2025.
What does the evidence show for Talazoparib in Breast Cancer?
Talazoparib has both completed registered trials and synthesis-level publications linked to Breast Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.