Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2026-01-05 @ 5:24 PM
Study NCT ID:
NCT03238703
Status:
WITHDRAWN
Last Update Posted:
2018-12-27
First Post:
2017-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Study Overview
Official Title:
An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)
Status:
WITHDRAWN
Status Verified Date:
2018-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administrative closure based on sponsor recommendation, prior to subject enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2017-00724 | REGISTRY | CTRP (Clinical Trial Reporting Program) | View | |
| 9764 | OTHER | Fred Hutch/University of Washington Cancer Consortium | View | |
| P30CA015704 | NIH | None | https://reporter.nih.gov/quic… | View |