Evidence map›Paper›PMID 30110579›Full record

Trial reportThe New England journal of medicine2018

Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation.

Jennifer K Litton, Hope S Rugo, Johannes Ettl, Sara A Hurvitz, Anthony Gonçalves, Kyung-Hun Lee, Louis Fehrenbacher, Rinat Yerushalmi, Lida A Mina, Miguel Martin and 8 more

6 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The New England journal of medicine, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 6 registered trials, which are not on this map. Cited by 1,203 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,203citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01945775 phase3completednot on this map

A phase 3, open-label, randomized parallel,2-arm,multi-center study of talazoparib(bmn 673) versus physician's choice in germline brca mutation subjects with locally advanced and/or metastatic breast cancer, who have received prior chemotherapy regimens for metastatic disease

TypeinterventionalSponsorPfizerRan2013 to 2021Enrolled431ConditionsBreast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene MutationArmstalazoparib, Physician's-Choice
NCT01989546 phase1 / phase2completednot on this map

Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2014 to 2020Enrolled9ConditionsAdvanced Ovarian Cancer, Primary Peritoneal Cancer, Advanced Breast Cancer, Advanced Solid TumorsArmsBMN 673
NCT06255392 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2024 to 2031Enrolled200ConditionsFludzoparib&#34, and Anti-angiogenic, HRD-positive/HER2-negative Advanced Breast CancerArmsFluzoparib, Apatinib Mesylate, Capecitabine tablets, Vinorelbine Tartrate Oral, Eribulin mesylate injection
NCT07066917 recruitingnot on this mapstarted 2024, after this paper: background citation

Mechanisms of Response and Resistance to Innovative Treatments in Patients With Locally Advanced or Metastatic Breast Cancer

Typeobservational_patient_registrySponsorHellenic Cooperative Oncology GroupRan2024 to 2029Enrolled150ConditionsMetastatic Breast Cancer
NCT07371910 phase3active not recruitingnot on this mapstarted 2024, after this paper: background citation

A Randomized, Open-label, Controlled, Multicenter Phase III Study of Fluorizoparib in Combination With Apatinib Versus Investigator's Choice Chemotherapy in Patients With HRD-positive, HER2-negative Advanced Breast Cancer

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2024 to 2031Enrolled200ConditionsMetastatic Breast Cancer, HRD-Positive/HER2-Negative Advanced Breast CancerArmsChemotherapy/ADC Regimen, Fluorizoparib, Apatinib, Physician's Choice Chemotherapy/ADC Regimen
NCT07617025 recruitingnot on this mapstarted 2024, after this paper: background citation

Prognostic and Predictive Role of Intrinsic Molecular Subtypes in BRCA-associated Breast Cancer

TypeobservationalSponsorAngela TossRan2024 to 2026Enrolled100ConditionsBreast Cancer
3 · Its place in the literature

Who cites it

1,203 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. SEOM-GEICAM-SOLTI clinical guidelines in advanced breast cancer (UPDATE 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
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1,143 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors.

Jennifer K LittonFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Hope S RugoFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Johannes EttlFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Sara A HurvitzFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Anthony GonçalvesFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Kyung-Hun LeeFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Louis FehrenbacherFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Rinat YerushalmiFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Lida A MinaFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Miguel MartinFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Henri RochéFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Young-Hyuck ImFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Ruben G W QuekFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Denka MarkovaFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Iulia C TudorFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Alison L HannahFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Wolfgang EiermannFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).
Joanne L BlumFrom the University of Texas M.D. Anderson Cancer Center, Houston (J.K.L.), and the Texas Oncology-Baylor Charles A. Sammons Cancer Center, US Oncology Network, Dallas (J.L.B.) - both in Texas; University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center (H.S.R.), and Pfizer (R.G.W.Q., D.M., I.C.T., A.L.H.), San Francisco, University of California, Los Angeles, Los Angeles (S.A.H.), and Kaiser Permanente, Northern California, Vallejo (L.F.) - all in California; the Department of Obstetrics and Gynecology, Klinikum Rechts der Isar, Technische Universität München (J.E.), and Interdisziplinäres Onkologisches Zentrum München (W.E.) - both in Munich, Germany; Institut Paoli-Calmettes, Marseille (A.G.), and Institut Claudius Regaud, Institut Universitaire du Cancer Toulouse, Toulouse (H.R.) - both in France; Seoul National University Hospital (K.-H.L.) and Samsung Medical Center (Y.-H.I.) - both in Seoul, South Korea; Rabin Medical Center, Beilinson Hospital, Petah Tikva, Israel (R.Y.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (L.A.M.); and Instituto de Investigación Sanitaria Gregorio Marañón, Centro de Investigación Biomédica en Red Oncología, Grupo Español de Investigación en Cáncer de Mama, Universidad Complutense, Madrid (M.M.).

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Scott Kopetz · 1985 to 2026
$290.8M
NCI NIH HHS P30 CA016672
6 · The paper itself

Abstract

backgroundThe poly(adenosine diphosphate-ribose) inhibitor talazoparib has shown antitumor activity in patients with advanced breast cancer and germline mutations in BRCA1 and BRCA2 ( BRCA1/2).

methodsWe conducted a randomized, open-label, phase 3 trial in which patients with advanced breast cancer and a germline BRCA1/2 mutation were assigned, in a 2:1 ratio, to receive talazoparib (1 mg once daily) or standard single-agent therapy of the physician's choice (capecitabine, eribulin, gemcitabine, or vinorelbine in continuous 21-day cycles). The primary end point was progression-free survival, which was assessed by blinded independent central review.

resultsOf the 431 patients who underwent randomization, 287 were assigned to receive talazoparib and 144 were assigned to receive standard therapy. Median progression-free survival was significantly longer in the talazoparib group than in the standard-therapy group (8.6 months vs. 5.6 months; hazard ratio for disease progression or death, 0.54; 95% confidence interval [CI], 0.41 to 0.71; P<0.001). The interim median hazard ratio for death was 0.76 (95% CI, 0.55 to 1.06; P=0.11 [57% of projected events]). The objective response rate was higher in the talazoparib group than in the standard-therapy group (62.6% vs. 27.2%; odds ratio, 5.0; 95% CI, 2.9 to 8.8; P<0.001). Hematologic grade 3-4 adverse events (primarily anemia) occurred in 55% of the patients who received talazoparib and in 38% of the patients who received standard therapy; nonhematologic grade 3 adverse events occurred in 32% and 38% of the patients, respectively. Patient-reported outcomes favored talazoparib; significant overall improvements and significant delays in the time to clinically meaningful deterioration according to both the global health status-quality-of-life and breast symptoms scales were observed.

conclusionsAmong patients with advanced breast cancer and a germline BRCA1/2 mutation, single-agent talazoparib provided a significant benefit over standard chemotherapy with respect to progression-free survival. Patient-reported outcomes were superior with talazoparib. (Funded by Medivation [Pfizer]; EMBRACA ClinicalTrials.gov number, NCT01945775 .).

Indexed as

Genes, BRCA1Genes, BRCA2Germ-Line MutationAdultAgedAged, 80 and overAntineoplastic AgentsBreast NeoplasmsDisease-Free SurvivalFemaleHumansMiddle AgedPatient Reported Outcome MeasuresPhthalazinesPoly(ADP-ribose) Polymerase InhibitorsQuality of LifeAntineoplastic AgentsPhthalazinesPoly(ADP-ribose) Polymerase Inhibitorstalazoparib

Identifiers

PMID30110579
PMCPMC10600918

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.