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Anastrozole / Tamoxifen / Fulvestrant · Phase 2 Trial
ClinicalTrials.gov · August 7, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 2 neoadjuvant endocrine therapy trial in postmenopausal women with ER-positive, HER2-negative invasive lobular carcinoma, completed with 201 participants. The study compares fulvestrant, anastrozole, and tamoxifen using change in Ki67 proliferative index as a surrogate endpoint to explore differential endocrine sensitivity in this breast cancer subtype. Results have not yet been reported in this registry record.
Phase 2, Interventional, Randomized, Parallel, Open label, Treatment purpose. Breast Cancer; Female. Intervention: tamoxifen; Anastrozole; fulvestrant. Compared with: Three-arm comparison: fulvestrant versus anastrozole versus tamoxifen. n = 201. 12 sites: United States.
This is a Phase 2 neoadjuvant endocrine therapy trial in postmenopausal women with ER-positive, HER2-negative invasive lobular carcinoma, completed with 201 participants. The study compares fulvestrant, anastrozole, and tamoxifen using change in Ki67 proliferative index as a surrogate endpoint to explore differential endocrine sensitivity in this breast cancer subtype. Results have not yet been reported in this registry record.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
If results show differential Ki67 reduction with fulvestrant compared to anastrozole or tamoxifen, this could support personalized endocrine therapy selection for invasive lobular carcinoma patients. However, clinical utility depends on whether Ki67 changes correlate with long-term clinical outcomes, which this surrogate endpoint study cannot directly establish.
Phase 2 interventional study of neoadjuvant endocrine therapy in a specific breast cancer subtype using a surrogate endpoint (Ki67 proliferative index); recruitment completed but results not yet reported in this registry record.
As stated by the source record.
Quoted from the source exactly as published.
If results show differential Ki67 reduction with fulvestrant compared to anastrozole or tamoxifen, this could support personalized endocrine therapy selection for invasive lobular carcinoma patients. However, clinical utility depends on whether Ki67 changes correlate with long-term clinical outcomes, which this surrogate endpoint study cannot directly establish.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT02206984). This is a study registration, not published results. Lead sponsor: Priscilla McAuliffe. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 201 participants (ACTUAL). Conditions: Breast Cancer. Interventions: DRUG: Tamoxifen; DRUG: Anastrozole; DRUG: Fulvestrant. Primary outcome measures: Change in Log-transformed Ki67 Proliferative Index , Baseline, Day 21-27. Brief summary: RATIONALE: Currently, adjuvant endocrine therapy often follows a "one-size-fits- all" approach, with most premenopausal women receiving tamoxifen, and most postmenopausal receiving aromatase inhibitor therapy. In current clinical practice, patients with invasive lobular carcinoma are treated no differently than patients with invasive ductal carcinoma based on the void of information specific to patients with this tumor type. Identification of a biological signal of tamoxifen and/or AI-resistance and/or fulvestrant-sensitivity in ILC patients would have dramatic implications for the future management of this breast cancer subtype. PURPOSE: To study whether fulvestrant is more effective than anastrozole or tamoxifen in reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in expression of ER and ER-regulated genes. Differential Ki67 effect in this study will serve as a surrogate for outcome of ILC patients on endocrine therapy. Primary Objective: To determine the change from baseline to post-treatment Ki67 values in ER-positive, HER2-negative ILC tissue derived from postmenopausal women awaiting definitive surgery or further neoadjuvant treatment who are randomized to 21-24 days of neoadjuvant endocrine treatments with fulvestrant (two 250 mg IM injections given on day 1), anastrozole (1mg given orally daily), or tamoxifen (20mg given orally daily).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.