Evidence map›Paper›PMID 24684785›Full record

Trial reportBreast cancer research : BCR2014

Phase 2 trial of everolimus and carboplatin combination in patients with triple negative metastatic breast cancer.

Jasmeet Singh, Yelena Novik, Stacey Stein, Matthew Volm, Marlene Meyers, Julia Smith, Coral Omene, James Speyer, Robert Schneider, Komal Jhaveri and 7 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Breast cancer research : BCR, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01127763 (Phase II Trial of RAD001 Plus Carboplatin in Patients With Triple-Negative Metastatic Breast Cancer), which is not on this map. Cited by 48 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 3 pooled it
4.4field-weighted citation impact, top 5% 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.

NCT01127763 phase2completednot on this map

Phase II Trial of RAD001 Plus Carboplatin in Patients With Triple-Negative Metastatic Breast Cancer

TypeinterventionalSponsorNYU Langone HealthRan2010 to 2013Enrolled25ConditionsBreast CancerArmsRAD001, Carboplatin
3 · Its place in the literature

Who cites it

48 citing papers in PubMed, 3 syntheses or guidelines pooled it, 84 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

17 authors at 4 institutions in 1 country.

Jasmeet Singh
Yelena Novik
Stacey Stein
Matthew Volm
Marlene Meyers
Julia Smith
Coral Omene
James Speyer
Robert Schneider
Komal Jhaveri
Silvia Formenti
Victoria Kyriakou
Benson Joseph
Judith D Goldberg
Xiaochun Li
Sylvia Adams
Amy Tiersten
New York University · USColumbia University Irving Medical Center · USIcahn School of Medicine at Mount Sinai · USYale Cancer Center · US

Funding

Vaccine FacilityP30CA016087 · NCI · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI ADRIANA HEGUY · 1985 to 2026
$83.1M
Immunomodulation of breast cancer via TLR7 agonist imiquimod and radiotherapy.R01CA161891 · NCI · WEILL MEDICAL COLL OF CORNELL UNIV · PI ADAMS, SYLVIA, FORMENTI, SILVIA C. · 2011 to 2015
$1.7M
NCI NIH HHS P30 CA016087NCI NIH HHS P30 CA16087NCI NIH HHS R01 CA161891
6 · The paper itself

Abstract

introductionRapamycin acts synergistically with platinum agents to induce apoptosis and inhibit proliferation in breast cancer cell lines. Combination of everolimus also known as RAD001 (oral mammalian target of rapamycin (mTOR) inhibitor) and carboplatin may have activity in metastatic triple-negative breast cancer (TNBC).

methodsThe primary objective of this study was to determine clinical benefit rate (CBR), that is (complete remission (CR) + partial remission (PR) + stable disease (SD) lasting ≥6 months) and the toxicity of everolimus/carboplatin in women with metastatic TNBC. Prior carboplatin was allowed. Treatment consisted of intravenous carboplatin area under the curve (AUC) 6 (later decreased to AUC 5 and subsequently to AUC 4) every 3 weeks with daily 5 mg everolimus.

resultsWe enrolled 25 patients in this study. Median age was 58 years. There were one CR, six PRs, seven SDs and eight PDs (progression of disease). CBR was 36% (95% confidence interval (CI) 21.1 to 57.4%). One SD was achieved in a patient progressing on single agent carboplatin. The median progression free survival (PFS) was 3 months (95% CI 1.6 to 4.6 months) and overall survival (OS) was 16.6 months (95% CI 7.3 months to not reached). There were seven patients (28%) with ≥ grade 3 thrombocytopenia; three (12%) with grade 3 neutropenia (no bleeding/febrile neutropenia) and one (4%) with grade 3 anemia. Greater hematological toxicity was seen in the first seven patients treated with carboplatin AUC5/6. After the amendment for starting dose of carboplatin to AUC 4, the regimen was well tolerated with only one out of 18 patients with grade 3 neutropenia and two patients with grade 3 thrombocytopenia. There was only one case of mucositis.

conclusionEverolimus-carboplatin was efficacious in metastatic TNBC. Dose limiting hematological toxicity was observed when AUC5/6 of carboplatin was combined with everolimus. However, carboplatin AUC 4 was well tolerated in combination with everolimus with continuing responses. TRIAL REGISTRATIONS: ClinicalTrials.gov NCT01127763.

Indexed as

AnemiaAntineoplastic Combined Chemotherapy ProtocolsCarboplatinDose-Response Relationship, DrugDrug Administration ScheduleEverolimusExanthemaFatigueFemaleHumansKaplan-Meier EstimateMiddle AgedNauseaRemission InductionSirolimusThrombocytopeniaCarboplatinEverolimusSirolimus

Identifiers

PMID24684785
PMCPMC4053575
OpenAlexW2106885203

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.