Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer
NCT ID: NCT03238703
Last Updated: 2018-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2018-09-01
2025-03-14
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (AI, SERM)
Patients 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.
Anastrozole
Given PO
Exemestane
Given PO
Laboratory Biomarker Analysis
Correlative studies
Letrozole
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Tamoxifen Citrate
Given PO
Toremifene Citrate
Given PO
Interventions
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Anastrozole
Given PO
Exemestane
Given PO
Laboratory Biomarker Analysis
Correlative studies
Letrozole
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Tamoxifen Citrate
Given PO
Toremifene Citrate
Given PO
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
60 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Vijayakrishna Gadi
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2017-00724
Identifier Type: REGISTRY
Identifier Source: secondary_id
9764
Identifier Type: OTHER
Identifier Source: secondary_id
9764
Identifier Type: -
Identifier Source: org_study_id