Evidence map›Paper›PMID 17912634›Full record

Trial reportBreast cancer research and treatment2007

Letrozole in the neoadjuvant setting: the P024 trial.

Matthew J Ellis, Cynthia Ma

Erratum issued 2 registry-linked trialsOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Breast cancer research and treatment, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
4.5field-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.

NCT01016665 nacompletednot on this map

Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study

TypeinterventionalSponsorFederal University of São PauloRan2005 to 2008Enrolled71ConditionsBreast CancerArmsAnastrozole
NCT02955394 phase2active not recruitingnot on this mapstarted 2017, after this paper: background citation

Randomized Phase II Trial of Preoperative Fulvestrant With or Without Enzalutamide in ER+/Her2- Breast Cancer

TypeinterventionalSponsorUniversity of Colorado, DenverRan2017 to 2027Enrolled61ConditionsBreast CancerArmsEnzalutamide, Fulvestrant
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 126 citations in OpenAlex.

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  8. Phase II trial with letrozole to maximum response as primary systemic therapy in postmenopausal patients with ER/PgR[+] operable breast cancer.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2012
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  16. Cytomorphological Disparities in Invasive Breast Cancer Cells following Neoadjuvant Endocrine Therapy and Chemotherapy.Pathobiology : journal of immunopathology, molecular and cellular biology · 2024
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4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

2 authors at 1 institution in 1 country.

Matthew J EllisMedical Oncology, Washington University, Campus Box 8056, 660 Euclid Ave, St Louis, MO 63110, USA. mellis@wustl.edu
Cynthia Ma
Washington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Neoadjuvant chemotherapy trials have consistently reported lower response rates in hormone receptor-positive (HR+) breast cancer when compared with HR- cases. Preoperative endocrine therapy has therefore become a logical alternative and has gained considerable momentum from the finding that aromatase inhibitors (AIs) are more effective than tamoxifen for HR+ breast cancer in both the neoadjuvant and adjuvant settings. The most convincing neoadjuvant trial to demonstrate the superiority of an AI versus tamoxifen was the P024 study, a large multinational double-blind trial in postmenopausal women with HR+ breast cancer ineligible for breast-conserving surgery. The overall response rate (ORR) was 55% for letrozole and 36% for tamoxifen (P<0.001). Significantly more letrozole-treated patients underwent breast-conserving surgery (45 vs. 35%, respectively; P=0.022). In addition, ORR was significantly higher with letrozole than tamoxifen in the human epidermal growth factor receptor HER1/HER2+ subgroup (P=0.0004). The clinical efficacy of letrozole in HER2+ breast cancer was confirmed by fluorescent in situ hybridization analysis and was found to be comparable to that of HER2- cases (ORR 71% in both subsets). Biomarker studies confirmed the superiority of letrozole in centrally assessed estrogen receptor-positive (ER+) tumors and found a strong relationship with the degree of ER positivity for both agents. Interestingly, letrozole was effective even in marginally ER+ tumors and, unlike tamoxifen, consistently reduced the expression from estrogen-regulated genes (progesterone receptor and trefoil factor 1). Furthermore, when analyzed by Ki67 immunohistochemistry, letrozole was significantly more effective than tamoxifen in reducing tumor proliferation (P=0.0009). Thus, neoadjuvant letrozole is safe and superior to tamoxifen in the treatment of postmenopausal women with HR+ locally advanced breast cancer.

Indexed as

AgedAged, 80 and overAntineoplastic Agents, HormonalAromatase InhibitorsBreast NeoplasmsDouble-Blind MethodErb-b2 Receptor Tyrosine KinasesFemaleHumansImmunohistochemistryLetrozoleMastectomy, SegmentalMiddle AgedNeoadjuvant TherapyNeoplasms, Hormone-DependentNitrilesAntineoplastic Agents, HormonalAromatase InhibitorsErb-b2 Receptor Tyrosine KinasesLetrozoleNitrilesReceptors, EstrogenTamoxifenTriazoles

Identifiers

PMID17912634
PMCPMC2001223
OpenAlexW2125589899

What OpenQuestion holds

Textmetadata
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.