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

StatusRecruiting
PhasePhase 2
Started2017-01-17
View on ClinicalTrials.gov ↗
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.

Amendment record

Amended 22 times since 2015-06-17; most recent filed 2026-07-24. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-31.

2026-07-24
Amendment Study Status v22
2025-07-23
Amendment Study Status v21
2024-07-25
Amendment Study Status v20
2023-12-15
Amendment Study Status v19
2022-12-14
Amendment Study Status, Contacts/Locations v18
2022-07-27
Amendment Study Status v17
2022-02-09
Amendment Study Status v16
2021-02-08
Amendment Study Status v15
2020-05-29
Amendment Study Status v14
2020-01-10
Amendment Study Status v13
2019-03-12
Amendment Study Status, Sponsor/Collaborators, Contacts/Locations v12
2018-07-19
Amendment Study Status v11
2018-07-06
Amendment Study Status v10
2017-06-22
Amendment Study Status, Study Description, Eligibility v9
2017-02-07
Amendment Study Status, Eligibility v8
2017-02-02
Amendment Study Status, Oversight, Contacts/Locations v7
2017-01-31
Amendment Study Status, Eligibility, Contacts/Locations v6
2017-01-18
Amendment Not Yet RecruitingRecruiting Study Status, Oversight, Contacts/Locations v5
2016-12-09
Amendment Study Identification, Study Status, IPDSharing v4
2016-10-27
Amendment Study Identification, Study Status, Sponsor/Collaborators, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v3
2016-06-02
Amendment Study Status v2
2015-11-30
Amendment Study Identification, Study Status v1
2015-06-17
Original filing
Trial Details
NCT Number NCT02476786
Lead Sponsor Washington University School of Medicine
Collaborators: Genomic Health®, Inc.
Conditions Breast Cancer, Cancer of Breast, Breast Neoplasms, Cancer of the Breast
Enrollment 50 participants
Start Date 2017-01-17
Primary Completion 2027-01-31 (estimated)
Study Completion 2032-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-27