NCT02476786

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Cancer of Breast
• Breast Neoplasms
• Cancer of the Breast

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-01-17
• Primary completion: 2027-01-31
• Completion: 2032-07-31
• First posted: 2015-06-19
• Last updated: 2025-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study