Evidence map›Paper›PMID 22138748›Full record

Trial reportBreast cancer research and treatment2012

Phase 2 study of neoadjuvant treatment with NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with HER-2 negative clinical stage II-IIIc breast cancer.

A J Montero, C M Diaz-Montero, Y E Deutsch, J Hurley, L G Koniaris, T Rumboldt, S Yasir, M Jorda, E Garret-Mayer, E Avisar and 7 more

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

Trial report in Breast cancer research and treatment, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00499122 (Phase II Study of Neoadjuvant Treatment With NOV-002 in Combination With Doxorubicin and Cyclophosphamide Followed by Docetaxel in Patients With Stages IIB-IIIC Breast Cancer), which is not on this map. Cited by 64 papers.

0numbers the graph read from it
0cells of the map it votes in
64citing papers in PubMed
2.7field-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.

NCT00499122 phase2completednot on this map

Phase II Study of Neoadjuvant Treatment With NOV-002 in Combination With Doxorubicin and Cyclophosphamide Followed by Docetaxel in Patients With Stages IIB-IIIC Breast Cancer

TypeinterventionalSponsorUniversity of MiamiRan2007 to 2011Enrolled41ConditionsBreast CancerArmsCyclophosphamide, Docetaxel, Doxorubicin, NOV 002
3 · Its place in the literature

Who cites it

64 citing papers in PubMed, 107 citations in OpenAlex.

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  14. Tumor immune microenvironment components and the other markers can predict the efficacy of neoadjuvant chemotherapy for breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023
    Review
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4 more citing papers are in PubMed but not listed here.

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 5 institutions in 1 country.

A J MonteroSylvester Comprehensive Cancer Center, University of Miami, 1475 NW 12th Avenue, Suite 3510 (D8-4), Miami, FL 33136, USA. amontero2@med.miami.edu
C M Diaz-Montero
Y E Deutsch
J Hurley
L G Koniaris
T Rumboldt
S Yasir
M Jorda
E Garret-Mayer
E Avisar
J Slingerland
O Silva
C Welsh
K Schuhwerk
P Seo
M D Pegram
S Glück
Sylvester Comprehensive Cancer Center · USUniversity of Miami · USMUSC Hollings Cancer Center · USNovel (United States) · USThomas Jefferson University Hospital · US

Funding

Translational Science Laboratory Shared ResourceP30CA138313 · NCI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI RAYMOND N. DUBOIS · 2009 to 2026
$42.7M
Enhancing T-Cell Responses with the Glutathione Mimetic NOV-002 in Breast CancerK23CA148893 · NCI · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI MONTERO, ALBERTO JOSE · 2010 to 2014
$798k
NCI NIH HHS K23 CA148893NCI NIH HHS K23-CA148893-01NCI NIH HHS P30 CA138313
6 · The paper itself

Abstract

NOV-002 (a formulation of disodium glutathione disulfide) modulates signaling pathways involved in tumor cell proliferation and metastasis and enhances anti-tumor immune responsiveness in tumor models. The addition of NOV-002 to chemotherapy has been shown to increase anti-tumor efficacy in animal models and some early phase oncology trials. We evaluated the clinical effects of NOV-002 in primary breast cancer, whether adding NOV-002 to standard preoperative chemotherapy increased pathologic complete response rates (pCR) at surgery, and determined whether NOV-002 mitigated hematologic toxicities of chemotherapy and whether levels of myeloid derived suppressor cells (MDSC) were predictive of response. Forty-one women with newly diagnosed stages II-IIIc HER-2 negative breast cancer received doxorubicin-cyclophosphamide followed by docetaxel (AC → T) every 3 weeks and concurrent daily NOV-002 injections. The trial was powered to detect a doubling of pCR rate from 16 to 32% with NOV-002 plus AC → T (α = 0.05, β = 80%). Weekly complete blood counts were obtained as well as circulating MDSC levels on day 1 of each cycle were quantified. Of 39 patients with 40 evaluable tumors, 15 achieved a pCR (38%), meeting the primary endpoint of the trial. Concurrent NOV-002 resulted in pCR rates for AC → T chemotherapy higher than previously reported. Patients with lower levels of circulating MDSCs at baseline and on the last cycle of chemotherapy had significantly higher probability of a pCR (P = 0.02). Further evaluation of NOV-002 in a randomized study is warranted.

Indexed as

AdolescentAdultAgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCisplatinCombined Modality TherapyCyclophosphamideDisease-Free SurvivalDocetaxelDoxorubicinDrug CombinationsErb-b2 Receptor Tyrosine KinasesFemaleGlutathione DisulfideAntineoplastic AgentsCisplatinCyclophosphamideDocetaxelDoxorubicinDrug CombinationsERBB2 protein, humanErb-b2 Receptor Tyrosine KinasesGlutathione DisulfideNOV 002Taxoids

Identifiers

PMID22138748
PMCPMC3697917
OpenAlexW2169934255

What OpenQuestion holds

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LicenceTDM
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.