NCT02476786

Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

Recruiting now Phase 2 Last updated 28 July 2025

What this trial tests

Phase 2 trial testing FACT-B in Breast Cancer in 50 participants. Currently enrolling.

Timeline

17 January 2017

Primary endpoint
31 January 2027

31 July 2032

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	50
Start date	17 January 2017
Primary completion	31 January 2027
Estimated completion	31 July 2032
Sites	1 location across United States

Drugs / interventions tested

• FACT-B
• Goserelin (goserelin) — full drug profile →
• Anastrozole (anastrozole) — full drug profile →
• Exemestane (exemestane) — full drug profile →
• Fulvestrant (fulvestrant) — full drug profile →
• Tamoxifen
• Archived tissue collection

Conditions studied

• Breast Cancer — all drugs for Breast Cancer →
• Cancer of Breast — all drugs for Cancer of Breast →
• Breast Neoplasms — all drugs for Breast Neoplasms →
• Cancer of the Breast — all drugs for Cancer of the Breast →

Sponsor

Washington University School of Medicine

Who can join

70 and older, female only, with Breast Cancer or Cancer of Breast. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Delineating intra-tumoral heterogeneity and tumor evolution in breast cancer using precision-based approaches.
   Xulu KR, Nweke EE, Augustine TN. · · 2023 · cited 7× · PMID 37662839 · DOI 10.3389/fgene.2023.1087432
2. Harnessing pyroptosis in breast cancer therapy: immunological mechanisms and emerging biomaterial strategies.
   Asiedu RKF, Souley Abdou M, Wei R, Xiao Z, et al · · 2026 · PMID 41820292 · DOI 10.1038/s41420-026-02996-1