Study Stopped
Administrative closure based on sponsor recommendation, prior to subject enrollment
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)
3 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2018
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2017
CompletedFirst Posted
Study publicly available on registry
August 3, 2017
CompletedStudy Start
First participant enrolled
September 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 14, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 14, 2025
CompletedDecember 27, 2018
December 1, 2018
4.5 years
July 31, 2017
December 26, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Conversion from oral endocrine therapy for any reason to guideline-directed therapy
Includes clinical or radiographic progression, patient preference, endocrine therapy intolerance or toxicity, or death from any cause. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
Up to 5 years
Secondary Outcomes (7)
Advanced imaging (if performed on any subset of patients)
Up to 5 years
Cost-effectiveness and patient-centeredness outcomes defined as financial toxicity and solubility, quality of life (physical, mental, emotional changes) on endocrine therapy, and, access to support services
Up to 5 years
Effect of age
Up to 5 years
Effect of comorbidity severity interaction
Up to 5 years
Effect of type of endocrine therapy type (selective estrogen receptor modifier versus aromatase inhibitor)
Up to 5 years
- +2 more secondary outcomes
Study Arms (1)
Treatment (AI, SERM)
EXPERIMENTALPatients receive exemestane PO 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.
Interventions
Given PO
Ancillary studies
Given PO
Given PO
Eligibility Criteria
You may qualify if:
- Able to provide written informed consent
- A diagnosis of invasive breast cancer, with or without an in situ component, that is:
- Originally identified by screening mammography
- Characterized by standard diagnostic mammography +/- breast ultrasound
- Clinically node negative
- Confirmed by breast magnetic resonance imaging (MRI) in a facility that maintains active American College of Radiology (ACR) accreditation to be of low clinical stage (=\< 2 cm, node negative, unifocal invasive)
- Estrogen receptor (ER) and progesterone receptor (PR) Allred scored, each \> 5/8
- Her2 negative using American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines
- ki-67 proliferation scored, \< 20%
- Clinical Nottingham grade 1 or 2
- Scored on the MammaPrint 70-gene breast cancer recurrence assay as low risk
- Prior to the discovery of the breast cancer, clinically post-menopausal as defined as: i) one or more years from last menses; or ii) history of oophorectomy; or iii) follicle stimulating hormone (FSH) test result in the post-menopause reference range
- Willing to accept oral endocrine therapy with a third generation aromatase inhibitor (AI) or selective estrogen receptor modifier (SERM)
- Willing to undergo routine surveillance with breast ultrasound and/or mammography
You may not qualify if:
- Known contraindication to aromatase inhibitor or SERM therapy
- Pregnant at time of or within prior year of diagnosis
- Clinically detected or palpable disease prior to biopsy in either breast or ipsilateral axilla
- Prior history of invasive breast cancer or ductal breast carcinoma in situ (DCIS)
- Prior use of aromatase inhibitor therapy apart from assisted reproduction
- Prior use of SERM
- Unmanaged/uncontrolled mental health disorder
- Life expectancy \< 6 months (m) for any cause
- Biopsy confirmed multifocal, multicentric, or contralateral disease that is invasive or non-invasive
- DCIS with focal invasion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fred Hutchinson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vijayakrishna Gadi
Fred Hutch/University of Washington Cancer Consortium
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2017
First Posted
August 3, 2017
Study Start
September 1, 2018
Primary Completion
March 14, 2023
Study Completion
March 14, 2025
Last Updated
December 27, 2018
Record last verified: 2018-12
Data Sharing
- IPD Sharing
- Will not share