Evidence map›Paper›PMID 20976541›Full record

Trial reportBreast cancer research and treatment2011

Phase I/II study of sorafenib with anastrozole in patients with hormone receptor positive aromatase inhibitor resistant metastatic breast cancer.

Claudine Isaacs, Pia Herbolsheimer, Minetta C Liu, Mary Wilkinson, Yvonne Ottaviano, Gina G Chung, Robert Warren, Jennifer Eng-Wong, Philip Cohen, Karen L Smith and 3 more

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

Trial report in Breast cancer research and treatment, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.1field-weighted citation impact, top 13% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 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

13 authors at 5 institutions in 1 country.

Claudine IsaacsLombardi Comprehensive Cancer Center, Georgetown University, 3800 Reservoir Road, Washington, DC 20057, USA. isaacsc@georgetown.edu
Pia Herbolsheimer
Minetta C Liu
Mary Wilkinson
Yvonne Ottaviano
Gina G Chung
Robert Warren
Jennifer Eng-Wong
Philip Cohen
Karen L Smith
Karen Creswell
Antonella Novielli
Rebecca Slack
Georgetown University · USGeorgetown University Medical Center · USMedStar Franklin Square Medical Center · USVirginia Oncology Associates · USYale Cancer Center · US

Funding

Tissue Culture Shared ResourceP30CA051008 · NCI · GEORGETOWN UNIVERSITY · PI STEPHEN W BYERS · 1990 to 2026
$71.5M
NCI NIH HHS 3 P30CA051008-15S3NCI NIH HHS P30 CA051008
6 · The paper itself

Abstract

We evaluated the use of sorafenib to overcome resistance to aromatase inhibitors (AIs) in patients with metastatic breast cancer who had disease recurrence or progression while on AIs. We performed a multi-institution phase I/II study of sorafenib and anastrozole 1 mg daily in 35 postmenopausal females with hormone receptor positive metastatic breast cancer resistant to AIs. Primary objectives were to determine the dose of sorafenib in conjunction with anastrozole and the clinical benefit rate (CBR) (complete response [CR], partial response [PR], or stable disease [SD] ≥ 24 weeks). Secondary objectives were to determine toxicity and to evaluate if response was associated with change in number of circulating endothelial cells or circulating endothelial progenitor cells. Based on the phase I portion, sorafenib 400 mg twice daily was selected as the phase II dose. Among 35 patients, 7 had SD ≥ 24 weeks, 1 had PR ≥ 24 weeks, and 14 had progressive disease (PD) ≤ 24 weeks, corresponding to a CBR of 23%. The most common adverse events (all; Grade 3/4) were fatigue (66%; 17%), diarrhea (63%; 6%), nausea (60%; 9%), and hand-foot syndrome (57%; 34%). Dose reduction occurred in 77% of the patients and 31% came off study due to toxicity. The combination of sorafenib and anastrozole demonstrated a 23% CBR in patients with hormone receptor positive, AI-resistant metastatic breast cancer, which may be attributable to the restoration of sensitivity to AIs. Toxicities occurred frequently resulting in a high rate of discontinuation.

Indexed as

Drug Resistance, NeoplasmAdultAgedAnastrozoleAntineoplastic Combined Chemotherapy ProtocolsAromatase InhibitorsBenzenesulfonatesBreast NeoplasmsDisease-Free SurvivalEndothelial CellsFemaleHumansKaplan-Meier EstimateMiddle AgedNiacinamideNitrilesAnastrozoleAromatase InhibitorsBenzenesulfonatesNiacinamideNitrilesPhenylurea CompoundsProtein Kinase InhibitorsPyridinesReceptors, EstrogenReceptors, ProgesteroneSorafenibTriazoles

Identifiers

PMID20976541
PMCPMC3756315
OpenAlexW2084847779

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.