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RECRUITING
NCT02476786
PHASE2

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

Sponsor: Washington University School of Medicine

View on ClinicalTrials.gov

Summary

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.

Official title: Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score

Key Details

Gender

FEMALE

Age Range

70 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2017-01-17

Completion Date

2032-07-31

Last Updated

2025-07-28

Healthy Volunteers

No

Interventions

BEHAVIORAL

FACT-B

The FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms/concerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness).

DRUG

Goserelin

DRUG

Anastrozole

DRUG

Exemestane

DRUG

Fulvestrant

DRUG

Tamoxifen

OTHER

Archived tissue collection

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States