NCT03238703

Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer

An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies how well endocrine therapy works in treating patients with HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells. Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators may lessen the amount of estrogen made by the body.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the conversion rate from a standard low-toxicity approach to guideline-directed therapy which includes surgery +/- radiation therapy as a result of progression of disease or patient/provider choice. II. To examine factors that might differ between those who convert from the low-toxicity approach to the guideline-directed therapy and those do not convert. SECONDARY OBJECTIVES: I. To measure the safety and clinical effectiveness of systemic endocrine therapy used in a prolonged neoadjuvant fashion. II. To evaluate the impact of risk-stratified care in Quality-Adjusted Life Years (QALY) and QALY gains. III. To estimate the cost savings of indefinitely delaying surgery and radiation in favor of systemic endocrine therapy alone. OUTLINE: Patients receive exemestane orally (PO) once daily (QD), anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up periodically.

Conditions

• HER2/Neu Negative
• Invasive Breast Carcinoma
• Postmenopausal
• Stage 0 Breast Cancer
• Stage IA Breast Cancer

Interventions

Type	Name	Description
DRUG	Anastrozole	Given PO
DRUG	Exemestane	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Letrozole	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies
DRUG	Tamoxifen Citrate	Given PO
DRUG	Toremifene Citrate	Given PO

Timeline

• Start date: 2018-09-01
• Primary completion: 2023-03-14
• Completion: 2025-03-14
• First posted: 2017-08-03
• Last updated: 2018-12-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study