Trial reportBMC cancer2014
FemZone trial: a randomized phase II trial comparing neoadjuvant letrozole and zoledronic acid with letrozole in primary breast cancer patients.
Trial report in BMC cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 4 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
11 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Surgical outcomes of neoadjuvant endocrine treatment in early breast cancer: meta-analysis.BJS open · 2024Pooled it
- Bone-modifying agents for reducing bone loss in women with early and locally advanced breast cancer: a network meta-analysis.The Cochrane database of systematic reviews · 2024Pooled it
- Bisphosphonates and other bone agents for breast cancer.The Cochrane database of systematic reviews · 2017Pooled it
- Neoadjuvant Endocrine Therapy for Estrogen Receptor-Positive Breast Cancer: A Systematic Review and Meta-analysis.JAMA oncology · 2016Pooled it
- A Phase II Randomized Study of Neoadjuvant Letrozole Plus Alpelisib for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer (NEO-ORB).Clinical cancer research : an official journal of the American Association for Cancer Research · 2019Trial
- Update Breast Cancer 2020 Part 3 - Early Breast Cancer.Geburtshilfe und Frauenheilkunde · 2020Article
- Efficacy and acceptability of neoadjuvant endocrine therapy in patients with hormone receptor-positive breast cancer: A network meta-analysis.Journal of cellular physiology · 2019Review
- Update Breast Cancer 2018 (Part 1) - Primary Breast Cancer and Biomarkers.Geburtshilfe und Frauenheilkunde · 2018Article
- Skeletal metastases from breast cancer: pathogenesis of bone tropism and treatment strategy.Clinical & experimental metastasis · 2015Review
- Survival benefit of zoledronic Acid in postmenopausal breast cancer patients receiving aromatase inhibitors.Journal of breast cancer · 2014Article
- The effects of zoledronate on monocyte-derived dendritic cells from melanoma patients differ depending on the clinical stage of the disease.Human vaccines & immunotherapeutics · 2014Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
23 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe objective of this prospectively randomized phase II trial (Trial registration: EUCTR2004-004007-37-DE) was to compare the clinical response of primary breast cancer patients to neoadjuvant therapy with letrozole alone (LET) or letrozole and zoledronic acid (LET + ZOL).
methodsPatients were randomly assigned to receive either LET 2.5 mg/day (n = 79) or the combination of LET 2.5 mg/day and a total of seven infusions of ZOL 4 mg every 4 weeks (n = 89) for 6 months. Primary endpoint was clinical response rate as assessed by mammogram readings. The study was terminated prematurely due to insufficient recruitment. We report here on an exploratory analysis of this data.
resultsCentral assessment of tumor sizes during the treatment period was available for 131 patients (66 LET, 65 LET + ZOL). Clinical responses (complete or partial) were seen in 54.5% (95% CI: 41.8-66.9) of the patients in the LET arm and 69.2% (95% CI: 56.6-80.1) of those in the LET + ZOL arm (P = 0.106). A multivariate model showed an OR of 1.72 (95% CI: 0.83-3.59) for the experimental arm.
conclusionNo increase in the clinical response rate was observed with the addition of ZOL to a neoadjuvant treatment regimen with LET. However a trend towards a better reponse in the LET + ZOL arm could be observed. This trend is consistent with previous studies that have investigated the addition of ZOL to chemotherapy, and it may support the evidence for a direct antitumor action of zoledronic acid.
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