Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2011
Randomized phase II neoadjuvant comparison between letrozole, anastrozole, and exemestane for postmenopausal women with estrogen receptor-rich stage 2 to 3 breast cancer: clinical and biomarker outcomes and predictive value of the baseline PAM50-based intrinsic subtype--ACOSOG Z1031.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 273 papers, 10 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 Randomized Phase III Trial Comparing 16 to 18 Weeks of Neoadjuvant Exemestane (25 mg Daily), Letrozole (2.5 mg), or Anastrozole (1 mg) in Postmenopausal Women With Clinical Stage II and III Estrogen Receptor Positive Breast Cancer
Comparison of Neoadjuvant Aromatase Inhibitors With Ovarian Suppression Versus Chemotherapy in Premenopausal Patients With Hormone Receptor-positive Breast Cancer (COMPETE): a Randomized Phase 3 Trial
Phase Ib Study of Neoadjuvant DPX-Survivac, Aromatase Inhibition, and With/Without Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer
Who cites it
273 citing papers in PubMed, 10 syntheses or guidelines pooled it, 554 citations in OpenAlex.
- Guidance for Canadian Breast Cancer Practice: National Consensus Recommendations for the Systemic Treatment of Patients with HR+/HER2- Early Breast Cancer 2025.Current oncology (Toronto, Ont.) · 2026Guideline
- SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer (UPDATE 2025).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026Guideline
- Surgical outcomes of neoadjuvant endocrine treatment in early breast cancer: meta-analysis.BJS open · 2024Pooled it
- BCAR4 Expression as a Predictive Biomarker for Endocrine Therapy Resistance in Breast Cancer.Clinical breast cancer · 2024Pooled it
- Neoadjuvant Endocrine Therapy Compared to Neoadjuvant Chemotherapy in Node-Positive HR+, HER2- Breast Cancer (Nodal pCR and the Rate of ALND): A Systematic Review and Meta-Analysis.The breast journal · 2024Pooled it
- SEOM-GEICAM-SOLTI clinical guidelines for early-stage breast cancer (2022).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023Pooled it
- Role of Intrinsic Subtype Analysis with PAM50 in Hormone Receptors Positive HER2 Negative Metastatic Breast Cancer: A Systematic Review.International journal of molecular sciences · 2022Pooled it
- Comparing the reporting and conduct quality of exercise and pharmacological randomised controlled trials: a systematic review.BMJ open · 2021Pooled it
- Higher ER load is not associated with better outcome in stage 1-3 breast cancer: a descriptive overview of quantitative HR analysis in operable breast cancer.Breast cancer research and treatment · 2019Pooled it
- Neoadjuvant Endocrine Therapy for Estrogen Receptor-Positive Breast Cancer: A Systematic Review and Meta-analysis.JAMA oncology · 2016Pooled it
- Axillary Management and Outcomes After Neoadjuvant Endocrine Therapy in the Randomized PELOPS Trial.Annals of surgical oncology · 2026Trial
- Surgeon Perspectives on Axillary Management Following Neoadjuvant Endocrine Therapy: Results from a Qualitative Substudy of the PELOPS Trial.Annals of surgical oncology · 2026Trial
- Neoadjuvant therapy with an aromatase inhibitor and durvalumab in postmenopausal patients with hormone receptor-positive breast cancer.Breast cancer research and treatment · 2026Trial
- Ninety Days of Preoperative Endocrine Therapy Informs Patient and Physician Preference for Radiation Therapy: Primary Results from the Preoperative Window of Endocrine Therapy to Inform Radiation Therapy Decisions (POWER) Trial.Annals of surgical oncology · 2025Trial
- Neoadjuvant palbociclib in women with operable, hormone receptor-positive breast cancer.Endocrine-related cancer · 2025Trial
- Genomic alterations are associated with response to aromatase inhibitor therapy for ER-positive postmenopausal ductal carcinoma in situ: (CALGB 40903, Alliance).Breast cancer research : BCR · 2025Trial
- Pathologic complete response (pCR) rates for patients with HR+/HER2- high-risk, early-stage breast cancer (EBC) by clinical and molecular features in the phase II I-SPY2 clinical trial.Annals of oncology : official journal of the European Society for Medical Oncology · 2025Trial
- Neoadjuvant sunitinib plus exemestane in post-menopausal women with hormone receptor-positive/HER2-negative early-stage breast cancer (SUT_EXE-08): a phase I/II trial.Scientific reports · 2024Trial
- Tucidinostat Plus Exemestane as a Neoadjuvant in Early-Stage, Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer.The oncologist · 2024Trial
- AMEERA-4: a randomized, preoperative window-of-opportunity study of amcenestrant versus letrozole in early breast cancer.Breast cancer research : BCR · 2023Trial
213 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 1 institution in 1 country.
Funding
Abstract
purposePreoperative aromatase inhibitor (AI) treatment promotes breast-conserving surgery (BCS) for estrogen receptor (ER)-positive breast cancer. To study this treatment option, responses to three AIs were compared in a randomized phase II neoadjuvant trial designed to select agents for phase III investigations. PATIENTS AND
methodsThree hundred seventy-seven postmenopausal women with clinical stage II to III ER-positive (Allred score 6-8) breast cancer were randomly assigned to receive neoadjuvant exemestane, letrozole, or anastrozole. The primary end point was clinical response. Secondary end points included BCS, Ki67 proliferation marker changes, the Preoperative Endocrine Prognostic Index (PEPI), and PAM50-based intrinsic subtype analysis.
resultsOn the basis of clinical response rates, letrozole and anastrozole were selected for further investigation; however, no other differences in surgical outcome, PEPI score, or Ki67 suppression were detected. The BCS rate for mastectomy-only patients at presentation was 51%. PAM50 analysis identified AI-unresponsive nonluminal subtypes (human epidermal growth factor receptor 2 enriched or basal-like) in 3.3% of patients. Clinical response and surgical outcomes were similar in luminal A (LumA) versus luminal B tumors; however, a PEPI of 0 (best prognostic group) was highest in the LumA subset (27.1% v 10.7%; P = .004).
conclusionNeoadjuvant AI treatment markedly improved surgical outcomes. Ki67 and PEPI data demonstrated that the three agents tested are biologically equivalent and therefore likely to have similar adjuvant activities. LumA tumors were more likely to have favorable biomarker characteristics after treatment; however, occasional paradoxical increases in Ki67 (12% of tumors with > 5% increase after therapy) suggest treatment-resistant cells, present in some LumA tumors, can be detected by post-treatment profiling.
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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.