Evidence map›Paper›PMID 30996012›Full record

Trial reportThe oncologist2019

A Phase II Trial of Selinexor (KPT-330) for Metastatic Triple-Negative Breast Cancer.

Michael Shafique, Roohi Ismail-Khan, Martine Extermann, Dan Sullivan, Dawn Goodridge, David Boulware, Deanna Hogue, Hatem Soliman, Hung Khong, Hyo S Han

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The oncologist, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 44 citations in OpenAlex.

  1. Preclinical Assessment with Clinical Validation of Selinexor with Gemcitabine and Nab-Paclitaxel for the Treatment of Pancreatic Ductal Adenocarcinoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2020
    Trial
  2. Review
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Review
  15. Review
  16. Article
  17. Article
  18. Review
  19. Article
  20. Review
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

10 authors at 1 institution in 1 country.

Michael ShafiqueDepartment of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA michael.shafique@moffitt.org.
Roohi Ismail-KhanDepartment of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Martine ExtermannDepartment of Senior Adult Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Dan SullivanDepartment of Blood and Marrow Transplant, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Dawn GoodridgeDepartment of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
David BoulwareDepartment of Biostatistics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Deanna HogueDepartment of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Hatem SolimanDepartment of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Hung KhongDepartment of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Hyo S HanDepartment of Breast Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Moffitt Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

lessons learnedSingle-agent selinexor has limited activity in heavily pretreated patients with metastatic triple-negative breast cancer.Selinexor 60 mg by mouth twice weekly was generally well tolerated with a side-effect profile consistent with previous clinical trials.Future studies of selinexor in this population should focus on combination approaches and a biomarker-driven strategy to identify patients most likely to benefit.

backgroundThis phase II trial evaluated the safety, pharmacodynamics, and efficacy of selinexor (KPT-330), an oral selective inhibitor of nuclear export (SINE) in patients with advanced triple-negative breast cancer (TNBC).

methodsThis phase II trial was designed to enroll 30 patients with metastatic TNBC. Selinexor was given at 60 mg orally twice weekly on days 1 and 3 of each week, three of each 4-week cycle. The primary objective of this study was to determine the clinical benefit rate (CBR), defined as complete response + partial response + stable disease (SD) ≥12 weeks.

resultsTen patients with a median age of 60 years (range 44-71 years) were enrolled between July 2015 and January 2016. The median number of prior chemotherapy lines was 2 (range 1-5). A planned interim analysis for the first stage per protocol was performed. Three patients had SD and seven had progressive disease. On the basis of these results and predefined stoppage rules, the study was halted.

conclusionSelinexor was fairly well tolerated in patients with advanced TNBC but did not result in objective responses. However, clinical benefit rate was 30%, and further investigation of selinexor in this patient population should focus on combination therapies.

Indexed as

AdultAgedAntineoplastic AgentsFemaleFollow-Up StudiesHumansHydrazinesMiddle AgedNeoplasm MetastasisPrognosisSurvival RateTriazolesTriple Negative Breast NeoplasmsAntineoplastic AgentsHydrazinesselinexorTriazoles

Identifiers

PMID30996012
PMCPMC6656474
OpenAlexW2938776515

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.