Endocrine Response in Women With Invasive Lobular Breast Cancer
Public ClinicalTrials.gov record NCT02206984. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Trial of Endocrine Response in Women With Invasive Lobular Breast Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT02206984
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 201 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Not listed
- Sex
- Female
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 29, 2015
- Primary completion
- Jul 18, 2024
- Completion
- Jul 18, 2024
- Last update posted
- Aug 6, 2026
2015 – 2024
United States locations
- U.S. sites
- 12
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Comprehensive Cancer Center | Birmingham | Alabama | 35294 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143 | — |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| ALBERT EINSTEIN COLLEGE OF MEDICINE Montefiore Medical Center | The Bronx | New York | 10467 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27514 | — |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Josh Plassmeyer | Pittsburgh | Pennsylvania | 15213 | — |
| Lester and Sue Smith Breast Center, Baylor College of Medicine | Houston | Texas | 77030 | — |
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77064 | — |
| Univ. of Washington, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02206984, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 6, 2026 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02206984 live on ClinicalTrials.gov.