Evidence map›Paper›PMID 28623430›Full record

Trial reportBreast cancer research and treatment2017

A Phase I/II study of suberoylanilide hydroxamic acid (SAHA) in combination with trastuzumab (Herceptin) in patients with advanced metastatic and/or local chest wall recurrent HER2-amplified breast cancer: a trial of the ECOG-ACRIN Cancer Research Group (E1104).

Lori J Goldstein, Fengmin Zhao, Molin Wang, Ramona F Swaby, Joseph A Sparano, Neal J Meropol, Kapil N Bhalla, Christine M Pellegrino, R Katherine Alpaugh, Carla I Falkson and 2 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Breast cancer research and treatment, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
1.1field-weighted citation impact, top 23% 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

16 citing papers in PubMed, 24 citations in OpenAlex.

  1. Review
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  3. Precision epigenetic therapies in oncology.Cancer metastasis reviews · 2025
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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

12 authors at 7 institutions in 1 country.

Lori J GoldsteinFox Chase Cancer Center, Philadelphia, PA, USA. lori.goldstein@fccc.edu.
Fengmin ZhaoDana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA, USA.
Molin WangDana Farber Cancer Institute - ECOG-ACRIN Biostatistics Center, Boston, MA, USA.
Ramona F SwabyFox Chase Cancer Center, Philadelphia, PA, USA.
Joseph A SparanoWest Chester Medical Center, Valhalla, NY, USA.
Neal J MeropolFox Chase Cancer Center, Philadelphia, PA, USA.
Kapil N BhallaMD Anderson Cancer Center, Houston, TX, USA.
Christine M PellegrinoWest Chester Medical Center, Valhalla, NY, USA.
R Katherine AlpaughFox Chase Cancer Center, Philadelphia, PA, USA.
Carla I FalksonUniversity of Alabama, Birmingham, AL, England, UK.
Paula KleinBeth Israel Medical Center, New York, USA.
George W SledgeStanford University, Stanford, CA, USA.
Fox Chase Cancer Center · USDana-Farber Cancer Institute · USAugusta University · USIndiana University Melvin and Bren Simon Comprehensive Cancer CenterMount Sinai Beth Israel · USUniversity Hospitals Case Medical Center · USUniversity of Alabama · US

Funding

Project-006U10CA180820 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI Peter J ODwyer · 2014 to 2026
$167.6M
WORD PROCESSING CENTER--COREP30CA006927 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI Margaret von Mehren · 1985 to 2026
$138.8M
Statistics CoreU10CA180794 · NCI · DANA-FARBER CANCER INST · PI PAUL J CATALANO · 2014 to 2026
$111.2M
ECOG-ACRIN Biospecimen Bank to Support NCTNU24CA196172 · NCI · ECOG-ACRIN MEDICAL RESEARCH FOUNDATION · PI STANLEY R. HAMILTON, Scott D Jewell · 2015 to 2026
$41.1M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
Georgia CaResUG1CA189851 · NCI · AUGUSTA UNIVERSITY · PI Anand P Jillella · 2014 to 2026
$13.3M
Montefiore Academic Community NCORP ProgramUG1CA189859 · NCI · MONTEFIORE MEDICAL CENTER (BRONX, NY) · PI Balazs Halmos, Della Makower · 2014 to 2026
$10.8M
ONCOLOGYU10CA027525 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI GOLDSTEIN, LORI J · 1985 to 2013
$6.2M
CWRU Case Comprehensive Cancer Center NCTN Lead Academic Participating SiteU10CA180853 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI GERDS, AARON THOMAS, MACHTAY, MITCHELL · 2014 to 2018
$6.2M
Stanford University NCTN- Network Lead Academic SiteU10CA180816 · NCI · STANFORD UNIVERSITY · PI COUTRE, STEVEN EDWARD, LE, QUYNH-THU XUAN · 2014 to 2018
$2.8M
NCTN Deep South Research ConsortiumU10CA180855 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI BJORNSTI, MARY-ANN, FALKSON, CARLA I · 2014 to 2018
$2.6M
Building upon a tradition of excellence. The NCTN at Indiana UniversityU10CA180795 · NCI · INDIANA UNIVERSITY INDIANAPOLIS · PI MILLER, KATHY D. · 2014 to 2018
$2.6M
NCI NIH HHS P30 CA006927NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA027525NCI NIH HHS U10 CA180794NCI NIH HHS U10 CA180795NCI NIH HHS U10 CA180816NCI NIH HHS U10 CA180820NCI NIH HHS U10 CA180853NCI NIH HHS U10 CA180855NCI NIH HHS U24 CA196172NCI NIH HHS UG1 CA189851NCI NIH HHS UG1 CA189859
6 · The paper itself

Abstract

purposeSuberoylanilide hydroxamic acid (SAHA; vorinostat), a small molecule inhibitor of histone deacetylase, attenuates signaling pathways known to confer trastuzumab resistance. A combination of SAHA and trastuzumab may be a promising strategy to improve the efficacy of trastuzumab against breast cancer. In this Phase I/II study, we evaluated the toxicity and response rate after treatment with SAHA and trastuzumab in patients with HER2-overexpressing metastatic breast cancer with trastuzumab-resistant progressive disease.

methodsIn Phase I, the SAHA dose was modified in cohorts of 3-6 patients to find the dose level at which 0 or 1 patients experienced a dose-limiting toxicity (DLT) during the first cycle of therapy. In the Phase II study, response to the recommended dose identified in Phase I was based on the response evaluation criteria in solid tumors. Overall survival and time to progression were also evaluated.

resultsThe recommended dose was determined to be 200 mg twice a day on days 1-14 and IV trastuzumab 6 mg/kg on day 1 of a 21-day cycle (n = 6). The Phase II study (n = 10) was terminated when the pre-planned efficacy evaluation found that none of the patients in the primary analysis set responded to combination SAHA and trastuzumab treatment.

conclusionsIn patients with HER2-positive metastatic breast cancer who had relapsed or progressed during trastuzumab therapy, we observed no DLTs with SAHA 200 mg twice daily combined with trastuzumab; however, there was insufficient statistical evidence that adding SAHA reversed trastuzumab resistance in these patients.

Indexed as

Gene AmplificationAdultAgedAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorBreast NeoplasmsCombined Modality TherapyDisease ProgressionErb-b2 Receptor Tyrosine KinasesFemaleHumansHydroxamic AcidsKaplan-Meier EstimateMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingBiomarkers, TumorErb-b2 Receptor Tyrosine KinasesHydroxamic AcidsTrastuzumabVorinostatAnticancer therapyHistone deacetylaseResistanceToxicityTumor

Identifiers

PMID28623430
PMCPMC5682621
OpenAlexW2624781814

What OpenQuestion holds

Textmetadata
LicenceTDM
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.