Evidence map›Paper›PMID 30542377›Full record

ArticleTherapeutic advances in medical oncology2018

Phase Ib/II single-arm trial evaluating the combination of everolimus, lapatinib and capecitabine for the treatment of HER2-positive breast cancer with brain metastases (TRIO-US B-09).

Sara Hurvitz, Rashi Singh, Brad Adams, Julie A Taguchi, David Chan, Robert A Dichmann, Aurelio Castrellon, Eddie Hu, Jonathan Berkowitz, Aruna Mani and 8 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Therapeutic advances in medical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01783756 (Phase 1b/2 Single-arm Trial Evaluating the Combination of Lapatinib, Everolimus and Capecitabine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer With CNS Progression After Trastuzumab), which is not on this map. Cited by 22 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 16% 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.

NCT01783756 phase1 / phase2completednot on this map

Phase 1b/2 Single-arm Trial Evaluating the Combination of Lapatinib, Everolimus and Capecitabine for the Treatment of Patients With HER2-positive Metastatic Breast Cancer With CNS Progression After Trastuzumab

TypeinterventionalSponsorJonsson Comprehensive Cancer CenterRan2013 to 2019Enrolled9ConditionsCentral Nervous System Metastases, HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast CancerArmslapatinib ditosylate, everolimus, capecitabine, laboratory biomarker analysis
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

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  19. The Dual PI3K/mTOR Pathway Inhibitor GDC-0084 Achieves Antitumor Activity inClinical cancer research : an official journal of the American Association for Cancer Research · 2019
    Article
  20. Neratinib Plus Capecitabine Provides a Glimmer of Hope for a Daunting Disease.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2019
    Article
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

18 authors at 4 institutions in 1 country.

Sara HurvitzUniversity of California, Los Angeles, 10945 Le Conte Avenue, PVUB Suite 3360, Los Angeles, CA 90095, USA.
Rashi SinghUniversity of California, Irvine, Irvine, CA, USA.
Brad AdamsUniversity of California, Los Angeles, Los Angeles, CA, USA.
Julie A TaguchiRidley-Tree Cancer Center, Santa Barbara, CA, USA.
David ChanTorrance Health Association DBA, Torrance Memorial Physician Network, Redondo Beach, CA, USA.
Robert A DichmannCentral Coast Medical Oncology Corporation, Santa Maria, CA, USA.
Aurelio CastrellonMemorial Healthcare System, Hollywood, FL, USA.
Eddie HuUniversity of California, Los Angeles, Los Angeles, CA, USA.
Jonathan BerkowitzCentral Coast Medical Oncology Corporation, Santa Maria, CA, USA.
Aruna ManiMemorial Healthcare System, Hollywood, FL, USA.
Brian DiCarloSan Luis Obispo Oncology and Hematology Health Center, San Luis Obispo, CA, USA Coastal Integrative Cancer Care, San Luis Obispo, CA.
Rena CallahanUniversity of California, Los Angeles, Los Angeles, CA, USA.
Ira SmalbergTower Imaging Medical Group, Los Angeles, CA Tower Saint John's Imaging, Santa Monica, CA, USA.
Xiaoyan WangUniversity of California, Los Angeles, Los Angeles, CA, USA.
Ivana MeglarUniversity of California, Los Angeles, Los Angeles, CA, USA.
Diego MartinezUniversity of California, Los Angeles, Los Angeles, CA, USA.
Evthokia HobbsUniversity of California, Los Angeles, Los Angeles, CA, USA.
Dennis J SlamonUniversity of California, Los Angeles, Los Angeles, CA, USA.
University of California, Los Angeles · USMemorial Healthcare System · USTorrance Memorial Medical Center · USUniversity of California, Irvine · US

Funding

Women's CancersP30CA016042 · NCI · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI Samuel Wheeler French · 1985 to 2026
$134.5M
NCI NIH HHS P30 CA016042
6 · The paper itself

Abstract

backgroundImproving outcomes for patients with human epidermal growth factor 2-positive (HER2+) central nervous system (CNS) metastases remains an unmet clinical need. This trial evaluated a novel combination of everolimus, lapatinib and capecitabine for this disease.

methodsPatients with trastuzumab-pretreated, HER2+ breast cancer brain metastasis without prior therapy with a mammalian target of rapamycin (mTOR) inhibitor were eligible. Patients received lapatinib and everolimus daily (continuously) and capecitabine twice daily (d1-14) in 21-d cycles. The primary endpoint was the 12-week CNS objective response rate (ORR). Secondary endpoints included safety, progression-free survival (PFS), overall survival (OS), best CNS ORR and extra-CNS ORR.

resultsA total of 19 participants were enrolled and treated with ⩾1 dose of the study drug. The median age was 58.5 years, the median number of therapies for metastatic breast cancer was 2.5 (0-11). Pretrial, 74% of participants had received prior lapatinib, capecitabine or both. A total of 63% had received previous CNS radiation or surgical resection and CNS radiation. The maximum tolerated doses were lapatinib at 1000 mg, everolimus at 10 mg, and capecitabine at 1000 mg/m

conclusionsThis novel triplet combination of lapatinib, everolimus, and capecitabine is well tolerated and yielded a 27% response rate in the CNS at 12 weeks in heavily pretreated participants. Larger studies are warranted to further evaluate this regimen.

trial registrationClinicalTrials.gov: NCT01783756. Registered 05 February 2013, https://clinicaltrials.gov/ct2/show/NCT01783756.

Indexed as

capecitabinechemotherapyeverolimusHER2+ breast cancerlapatinibmetastatic brain tumorsPI3K/Akt/mTOR inhibitortyrosine kinase inhibitor

Identifiers

PMID30542377
PMCPMC6236634
OpenAlexW2899655750

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.