Invasive Breast Carcinoma Clinical Trial
Official title:
An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)
Verified date | December 2018 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 14, 2025 |
Est. primary completion date | March 14, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 60 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Advanced imaging (if performed on any subset of patients) | Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. 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 | 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 | Comparisons will be made to historical benchmarks for similar patients managed in a conventional locoregional manner for early-stage breast cancer. 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 | Effect of age | Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. 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 | Effect of comorbidity severity interaction | Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. 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 | Effect of type of endocrine therapy type (selective estrogen receptor modifier versus aromatase inhibitor) | Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. 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 | Effects emanating from tertiary care | Will be compared to a concurrent group of patients managed in the conventional manner with upfront surgery +/- radiation therapy followed by systemic endocrine therapy. 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 | Progression of disease while on primary endocrine therapy, as measured objectively by routine diagnostic breast imaging (mammography and/or ultrasound) | 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 |
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