Breast Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Study is for people with:

Breast Cancer

Phase:

Phase 4

Study ID:

NCT03238703

Recruitment Status:

Withdrawn

Sponsor:

Fred Hutchinson Cancer Center

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There is 1 Location for this study

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Fred Hutch/University of Washington Cancer Consortium
Seattle Washington, 98109, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 4

Study ID:

NCT03238703

Recruitment Status:

Withdrawn

Sponsor:


Fred Hutchinson Cancer Center

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