Evidence map›Paper›PMID 35907135›Full record

ArticleBreast cancer (Tokyo, Japan)2022

Efficacy and safety of talazoparib in Japanese patients with germline BRCA-mutated locally advanced or metastatic breast cancer: results of the phase 1 dose-expansion study.

Haruru Kotani, Norikazu Masuda, Toshinari Yamashita, Yoichi Naito, Tetsuhiko Taira, Kenichi Inoue, Masato Takahashi, Kan Yonemori, Shigeyuki Toyoizumi, Yuko Mori and 3 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Breast cancer (Tokyo, Japan), 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03343054 (A PHASE 1 STUDY OF THE SAFETY, PHARMACOKINETICS AND ANTI-TUMOR ACTIVITY OF TALAZOPARIB, POLY), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
0.6field-weighted citation impact, top 30% of its field
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.

NCT03343054 phase1completednot on this map

A phase 1 study of the safety, pharmacokinetics and anti-tumor activity of talazoparib, poly (adp-ribose) polymerase (parp) inhibitor, in japanese patients with advanced solid tumors

TypeinterventionalSponsorPfizerRan2017 to 2024Enrolled28ConditionsNeoplasms, Breast NeoplasmsArmstalazoparib
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 7 institutions in 1 country.

Haruru KotaniAichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan. k.haruru@aichi-cc.jp.ORCID http://orcid.org/0000-0002-0355-9294
Norikazu MasudaNational Hospital Organization Osaka National Hospital, 2-1-14 Hoenzaka, Chuo-ku, Osaka-shi, Osaka, 540-0006, Japan.ORCID http://orcid.org/0000-0002-7302-0278
Toshinari YamashitaKanagawa Cancer Center, 2-3-2 Nakao, Asahi-ku, Yokohama, Kanagawa, 241-8515, Japan.ORCID http://orcid.org/0000-0002-6479-1660
Yoichi NaitoNational Cancer Center Hospital East, 6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan.ORCID http://orcid.org/0000-0002-8490-9064
Tetsuhiko TairaHakuaikai Medical Corporation Sagara Hospital, 3-31 Matsubara-cho Kagoshima, Kagoshima, 892-0833, Japan.ORCID http://orcid.org/0000-0002-3091-8168
Kenichi InoueSaitama Cancer Center, 780 Komuro, Ina-machi, Kitaadachi-gun, Saitama, 362-0806, Japan.ORCID http://orcid.org/0000-0003-2686-8732
Masato TakahashiNational Hospital Organization Hokkaido Cancer Center, Kikusui 4-jo 2-chome 3-54 Shiroishi-ku, Sapporo, Hokkaido, 003-0804, Japan.ORCID http://orcid.org/0000-0002-6641-9598
Kan YonemoriNational Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan.
Shigeyuki ToyoizumiPfizer R&D Japan, Shinjuku Bunka Quint Bldg. 3-22-7, Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan.ORCID http://orcid.org/0000-0002-7011-5263
Yuko MoriPfizer R&D Japan, Shinjuku Bunka Quint Bldg. 3-22-7, Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan.ORCID http://orcid.org/0000-0003-1919-2463
Takashi NagasawaPfizer R&D Japan, Shinjuku Bunka Quint Bldg. 3-22-7, Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan.ORCID http://orcid.org/0000-0002-1600-1062
Natsuki HoriPfizer R&D Japan, Shinjuku Bunka Quint Bldg. 3-22-7, Yoyogi, Shibuya-ku, Tokyo, 151-0053, Japan.ORCID http://orcid.org/0000-0003-4675-3975
Hiroji IwataAichi Cancer Center, 1-1 Kanokoden, Chikusa-ku, Nagoya, 464-8681, Japan.
Pfizer (Japan) · JPAichi Cancer Center · JPKanagawa Prefectural Hospital Organization · JPNational Cancer Center Hospital East · JPNational Hospital Organization Hokkaido Medical Center · JPOsaka National Hospital · JPSaitama Cancer Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTalazoparib, a poly(ADP-ribose) polymerase enzyme inhibitor, is approved for the treatment of patients with germline BRCA1/2 (gBRCA1/2)-mutated HER2-negative advanced breast cancer. This two-part study, a recently published dose-escalation part followed by the dose-expansion part reported here, evaluated the efficacy and safety of talazoparib in Japanese patients with gBRCA1/2-mutated advanced breast cancer.

methodsIn this open-label, multicenter phase 1 study (NCT03343054), the primary endpoint of the dose-expansion part was confirmed objective response rate (ORR), determined by investigator assessment (RECIST 1.1). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and pharmacokinetics. Patients received the recommended phase 2 dose (1 mg/day; 0.75 mg/day moderate renal impairment).

resultsNineteen Japanese patients with gBRCA1/2-mutated locally advanced or metastatic breast cancer were enrolled. Confirmed ORR was 57.9% (11/19; 90% confidence interval [CI] 36.8-77.0). Stable disease was observed in 36.8% (7/19) of patients. Per investigator assessment, median PFS was 7.2 months (95% CI 4.1-not estimable) and 12-month OS rate was 84.7% (90% CI 57.5-95.1). Median OS was not reached; 17/19 patients were alive and censored at 12 months. All patients experienced treatment-related adverse events (AEs); the majority were hematologic. The most common treatment-related AE was anemia (68.4%; [13/19]). Grade 3/4 treatment-related AEs were observed in 52.6% (10/19) of patients. During the safety period, there were no grade 5 treatment-emergent AEs, treatment-related serious AEs, or deaths.

conclusionsIn Japanese patients with gBRCA mutations and locally advanced or metastatic breast cancer, talazoparib monotherapy was generally well tolerated and resulted in clinically meaningful ORRs. CLINICALTRIALS: GOV IDENTIFIER: NCT03343054.

Indexed as

Antineoplastic AgentsBreast NeoplasmsFemaleGerm CellsGerm-Line MutationHumansJapanPhthalazinesPoly(ADP-ribose) Polymerase InhibitorsPoly(ADP-ribose) PolymerasesAntineoplastic AgentsPhthalazinesPoly(ADP-ribose) Polymerase InhibitorsPoly(ADP-ribose) PolymerasestalazoparibBRCABreast cancerJapanese patientsPARP inhibitorTalazoparib

Identifiers

PMID35907135
PMCPMC9587945
OpenAlexW4288903000

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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.