Status:
WITHDRAWN
Endocrine Therapy in Treating Patients With HER2 Negative, Low Risk Breast Cancer
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
HER2/Neu Negative
Invasive Breast Carcinoma
Eligibility:
FEMALE
60+ years
Phase:
PHASE4
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 ther...
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 d...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03238703
Start Date
September 1 2018
End Date
March 14 2025
Last Update
December 27 2018
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109