Evidence map›Paper›PMID 19073506›Full record

Trial reportClinical breast cancer2008

A phase II study of imatinib mesylate and capecitabine in metastatic breast cancer: Southwest Oncology Group Study 0338.

Helen K Chew, William E Barlow, Kathy Albain, Danika Lew, Allen Gown, Daniel F Hayes, Julie Gralow, Gabriel N Hortobagyi, Robert Livingston

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

Trial report in Clinical breast cancer, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00087152 (Phase II Trial Of Imatinib Mesylate), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
2.6field-weighted citation impact, top 10% 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.

NCT00087152 phase2completednot on this map

Phase II Trial Of Imatinib Mesylate (Gleevec®) (NSC-716051) In Combination With Capecitabine (Xeloda®) (NSC-712807) In Metastatic Breast Cancer

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2004 to 2008Enrolled27ConditionsBreast CancerArmsCapecitabine, Imatinib mesylate
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 39 citations in OpenAlex.

  1. Trial
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  4. Journal of clinical pathology · 2023
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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

9 authors at 7 institutions in 1 country.

Helen K ChewDepartment of Internal Medicine, Division of Hematology/Oncology, University of California Davis, Sacramento, CA 95817, USA. helen.chew@ucdmc.ucdavis.edu
William E Barlow
Kathy Albain
Danika Lew
Allen Gown
Daniel F Hayes
Julie Gralow
Gabriel N Hortobagyi
Robert Livingston
Cancer Research And Biostatistics · USLoyola University Chicago · USSWOG Cancer Research Network · USThe University of Texas MD Anderson Cancer Center · USUniversity of California Davis Medical Center · USUniversity of Michigan · USUniversity of Washington · US

Funding

SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0M
NORTHWEST COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035281 · NCI · TACOMA GENERAL HOSPITAL · PI KEECH, JOHN A · 1985 to 2013
$9.2M
Hawaii Minority-Based Clinical Community Oncology ProgramU10CA063844 · NCI · UNIVERSITY OF HAWAII AT MANOA · PI BERENBERG, JEFFREY LEE · 1994 to 2014
$9.0M
NM MINORITY-BASED COMMUNITY CLINICAL ONC. PROGRAMU10CA086780 · NCI · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI ROYCE, MELANIE E · 2000 to 2014
$8.8M
OZARKS REGIONAL COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045560 · NCI · ST. JOHN'S REGIONAL HEALTH CENTER · PI CARLSON, JAY W · 1987 to 2014
$8.2M
Montana Cancer Consortium CCOPU10CA067575 · NCI · MONTANA CANCER CONSORTIUM · PI MARCHELLO, BENJAMIN T. · 1995 to 2013
$6.5M
SOUTHWEST ONCOLOGY GROUPU10CA020319 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI GOODMAN, GARY E · 1985 to 2013
$5.1M
SOUTHWEST ONCOLOGY GROUP/UNIVERSITY OF CALIFORNIA, DAVISU10CA046441 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI GANDARA, DAVID R · 1988 to 2013
$4.8M
UNIVERSITY OF COLORADO-SOUTHWEST ONCOLOGY GROUPU10CA042777 · NCI · UNIVERSITY OF COLORADO DENVER · PI ELIAS, ANTHONY D · 1988 to 2013
$3.2M
NCI NIH HHS CA20319NCI NIH HHS CA35281NCI NIH HHS CA42777NCI NIH HHS CA45808NCI NIH HHS CA63850NCI NIH HHS CA86780NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA045807NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA063844NCI NIH HHS N01 CA067575NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035281NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA042777NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA063844NCI NIH HHS U10 CA063850NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA086780
6 · The paper itself

Abstract

backgroundImatinib mesylate is a potent inhibitor of the Bcr-Abl, c-Kit, and platelet-derived growth factor receptor (PDGFR) tyrosine kinases. On the basis of variable expression of c-Kit and PDGFR in breast cancer and of in vitro data supporting synergy between imatinib and capecitabine, the Southwest Oncology Group conducted a phase II trial of the combination in metastatic breast cancer. PATIENTS AND

methodsEligible patients had progressive, measurable metastatic breast cancer and received<or=2 previous chemotherapy regimens for metastatic disease. Previous 5-fluorouracil or capecitabine for metastatic disease was not allowed. Patients were accrued on a 2-stage design and received imatinib mesylate 400 mg by mouth daily and capecitabine at 1000 mg/m2 by mouth twice daily for 14 days of a 21-day cycle. The primary endpoint was the confirmed response rate (RR). Tumors were evaluated for c-Kit, PDGFR-beta, and hormone receptor expression.

resultsNineteen fully evaluable patients were enrolled, with a confirmed RR of 11% (95% CI, 1%-33%). Eleven percent had unconfirmed partial responses, and 42% had stable disease. The trial did not accrue to the second stage. The estimated 6-month progression-free survival was 16% (95% CI, 0%-32%), and the median overall survival was 14 months (95% CI, 7-15 months). The combination was well tolerated. Of 8 available tumor samples, 2 stained for c-Kit, and all had stromal staining for PDGFR-beta.

conclusionIn unselected patients, the combination of imatinib mesylate and capecitabine was well tolerated but did not result in improved RRs compared to those reported with capecitabine alone.

Indexed as

Administration, OralAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBreast NeoplasmsCapecitabineDeoxycytidineDrug SynergismFemaleFluorouracilHumansImatinib MesylateMiddle AgedPiperazinesProto-Oncogene Proteins c-kitBenzamidesCapecitabineDeoxycytidineFluorouracilImatinib MesylatePDGF receptor tyrosine kinasePiperazinesProto-Oncogene Proteins c-kitPyrimidinesReceptor, Platelet-Derived Growth Factor betaReceptors, Platelet-Derived Growth Factor

Identifiers

PMID19073506
PMCPMC3510680
OpenAlexW2078525645

What OpenQuestion holds

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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.