Sapanisertib Plus Exemestane or Fulvestrant in Women with Hormone Receptor-Positive/HER2-Negative Advanced or Metastatic Breast Cancer.
Journal
Clinical cancer research : an official journal of the American Association for Cancer Research
ISSN: 1557-3265
Titre abrégé: Clin Cancer Res
Pays: United States
ID NLM: 9502500
Informations de publication
Date de publication:
15 06 2021
15 06 2021
Historique:
received:
30
10
2020
revised:
09
02
2021
accepted:
31
03
2021
pubmed:
7
4
2021
medline:
8
4
2022
entrez:
6
4
2021
Statut:
ppublish
Résumé
This open-label, multicenter, phase IB/II study evaluated sapanisertib, a dual inhibitor of mTOR kinase complexes 1/2, plus exemestane or fulvestrant in postmenopausal women with hormone receptor-positive (HR Eligible patients had previously progressed on everolimus with exemestane/fulvestrant and received ≤3 (phase IB) or ≤1 (phase II) prior chemotherapy regimens. Patients received sapanisertib 3 to 5 mg every day (phase IB), or 4 mg every day (phase II) with exemestane 25 mg every day or fulvestrant 500 mg monthly in 28-day cycles. Phase II enrolled parallel cohorts based on prior response to everolimus. The primary objective of phase II was to evaluate antitumor activity by clinical benefit rate at 16 weeks (CBR-16). Overall, 118 patients enrolled in phase IB ( Sapanisertib plus exemestane or fulvestrant was well tolerated and exhibited clinical benefit in postmenopausal women with pretreated everolimus-sensitive or everolimus-resistant breast cancer.
Identifiants
pubmed: 33820779
pii: 1078-0432.CCR-20-4131
doi: 10.1158/1078-0432.CCR-20-4131
doi:
Substances chimiques
Androstadienes
0
Pyrazoles
0
Pyrimidines
0
Receptors, Estrogen
0
Receptors, Progesterone
0
Fulvestrant
22X328QOC4
Receptor, ErbB-2
EC 2.7.10.1
sapanisertib
JGH0DF1U03
exemestane
NY22HMQ4BX
Banques de données
ClinicalTrials.gov
['NCT02049957']
Types de publication
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
3329-3338Subventions
Organisme : NCI NIH HHS
ID : R01 CA214893
Pays : United States
Informations de copyright
©2021 American Association for Cancer Research.
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