Trial reportBreast cancer research : BCR2009
Extended adjuvant hormonal therapy with exemestane has no detrimental effect on the lipid profile of postmenopausal breast cancer patients: final results of the ATENA lipid substudy.
Trial report in Breast cancer research : BCR, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00810706 (A Phase III Randomized Parallel-Group Multicenter Trial, Designed to Compare 5 Years of Adjuvant Exemestane Versus 5 Years of Observation in Postmenopausal Women With Operable Breast Cancer Who Have Received 5-7 Years of Adjuvant Tamoxifen.), which is not on this map. Cited by 19 papers, 4 of them syntheses that pooled 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.
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.
A Phase III Randomized Parallel-Group Multicenter Trial, Designed to Compare 5 Years of Adjuvant Exemestane Versus 5 Years of Observation in Postmenopausal Women With Operable Breast Cancer Who Have Received 5-7 Years of Adjuvant Tamoxifen.
Who cites it
19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Risk of Cardiovascular Events and Lipid Profile Change in Patients with Breast Cancer Taking Aromatase Inhibitor: A Systematic Review and Meta-Analysis.Current oncology (Toronto, Ont.) · 2023Pooled it
- Cardiotoxicity of aromatase inhibitors and tamoxifen in postmenopausal women with breast cancer: a systematic review and meta-analysis of randomized controlled trials.Annals of oncology : official journal of the European Society for Medical Oncology · 2017Pooled it
- Putting the cardiovascular safety of aromatase inhibitors in patients with early breast cancer into perspective: a systematic review of the literature.Drug safety · 2011Pooled it
- Association Between Aromatase Inhibitors and Myocardial Infarction Morbidity in Women With Breast Cancer: A Meta-Analysis of Observational Studies.Cancer control : journal of the Moffitt Cancer CenterPooled it
- Association of Variants in Candidate Genes with Lipid Profiles in Women with Early Breast Cancer on Adjuvant Aromatase Inhibitor Therapy.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016Trial
- Comparison of changes in the lipid profile of postmenopausal women with early stage breast cancer treated with exemestane or letrozole.Journal of clinical pharmacology · 2012Trial
- Changes in LDL-cholesterol levels following aromatase inhibitor treatment in early postmenopausal breast cancer.European journal of epidemiology · 2025Article
- Aromatase Inhibitors and Plasma Lipid Changes in Postmenopausal Women with Breast Cancer: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2024Review
- The Cardiovascular Risks Associated with Aromatase Inhibitors, Tamoxifen, and GnRH Agonists in Women with Breast Cancer.Current atherosclerosis reports · 2023Review
- Adjuvant aromatase inhibitor therapy and early markers for cardiovascular disease in breast cancer survivors.Breast cancer research and treatment · 2022Article
- Cardiometabolic Effects of Endocrine Treatment of Estrogen Receptor-Positive Early Breast Cancer.Journal of the Endocrine Society · 2019Review
- The UZ Leuven Policy for Extended Adjuvant Anti-estrogen Therapy in Women With Early Estrogen Receptor-Positive Breast Cancer.Current treatment options in oncology · 2015Review
- Adjuvant endocrine therapy for early breast cancer: a systematic review of the evidence for the 2014 Cancer Care Ontario systemic therapy guideline.Current oncology (Toronto, Ont.) · 2015Review
- Clinical utility of exemestane in the treatment of breast cancer.International journal of women's health · 2015Review
- Status of adjuvant endocrine therapy for breast cancer.Breast cancer research : BCR · 2014Review
- Long-term efficacy and safety of exemestane in the treatment of breast cancer.Patient preference and adherence · 2013Article
- Exemestane in the adjuvant treatment of breast cancer in postmenopausal women.Breast cancer : basic and clinical research · 2011Article
- Minimizing early relapse and maximizing treatment outcomes in hormone-sensitive postmenopausal breast cancer: efficacy review of AI trials.Cancer metastasis reviews · 2010Review
- Adjuvant treatment of breast cancer in postmenopausal women: role of exemestane.Breast cancer (Dove Medical Press) · 2010Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionExtended adjuvant endocrine therapy for breast cancer with aromatase inhibitors may potentially alter the lipid profile of postmenopausal patients and thus increase the risk of developing cardiovascular disease. In this study, a subprotocol of the ATENA (Adjuvant post-Tamoxifen Exemestane versus Nothing Applied) trial, we compared the effect of the steroidal aromatase inactivator exemestane on the lipid profile of postmenopausal patients with operable breast cancer, in the adjuvant setting, with that of observation alone after completion of 5 to 7 years of primary treatment with tamoxifen.
methodsIn this open-label, randomized, parallel-group study, 411 postmenopausal patients with operable breast cancer, who had been treated with tamoxifen for 5 to 7 years, were randomized to either 5 additional years of exemestane (25 mg/day; n = 211) or observation only (n = 200). Assessments of total cholesterol (TC), high-density lipoprotein (HDL), low-density lipoprotein (LDL), and total serum triglycerides (TRG) were performed at baseline and then during each follow-up visit, performed at either 6 or 12 months, according to the center's clinical practice, until completing 24 months in the study.
resultsTC and LDL levels increased significantly across time for both arms; TC increase was more pronounced for the observation arm, and that was sustained up to 24 months. HDL levels decreased significantly across time for the exemestane arm, whereas no significant change was detected across time for the observation arm. Triglyceride levels decreased significantly across time on both arms, with no difference detected in changes from baseline between the exemestane and the observation arms.
conclusionsExemestane lacks the beneficial effect of tamoxifen on lipids; however, sequential adjuvant treatment with exemestane in postmenopausal breast cancer patients after cessation of 5 to 7 years of tamoxifen does not appear to alter the lipid profile significantly compared with that of an observational arm.
trial registrationClinicalTrials.gov ID: NCT00810706.
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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.