- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03761420
Adjuvant Endocrine Therapy in Early Stage Breast Cancer: Adherence and Clinical Outcome
Adjuvant Endocrine Therapy in Early Stage Breast Cancer: Impact of Drug Adherence/Persistence on Clinical Outcome in Various Breast Cancer Subtypes
Breast cancer is the most common cancer among women in Norway. In 2016, 3402 new cases were diagnosed (3371 in women). Breast cancer is still the second most common cause of death from cancer among women with 585 breast cancer deaths in Norway in 2015. The majority of the patients (70-75 %) belong to the Luminal subtypes, which comprise the hormone receptor (oestrogen receptor (ER) and/or progesterone receptor (PR)) positive tumours.
The most important systemic adjuvant therapy in luminal breast cancers is a long-lasting administration of per-oral anti-oestrogen medication. A systemic hypo estrogenic state in the body may be created by the selective oestrogen receptor modulator tamoxifen or by inhibitors of the peripheral systemic aromatization of adrenal androgens into estrogens (aromatase inhibitors). Initially, tamoxifen was given adjuvant for 2 years, later prolonged to 5 years and recently an extension to 10 years has been recommended for premenopausal women. Aromatase inhibitors were introduced in Norwegian treatment guidelines in 2002. Currently, they are recommended in postmenopausal patients for 5 years, either as monotherapy or in concert with tamoxifen (aromatase inhibitors for 2 years followed by tamoxifen for 3 years).
In premenopausal breast cancer patients, tamoxifen still is the drug of choice. Two of the major underlying reasons for late recurrences in luminal breast cancer subtypes are development of endocrine resistance to tamoxifen and aromatase inhibitors or failure of taking the medication as prescribed. Higher mortality has been shown for breast cancer patients with reduced tamoxifen adherence. The patients' ability to follow instructions and recommendations are probably overestimated in controlled trials due to patient selection and close follow-up in the study setting. Some patients experience distressing side effects like hot flushes, fatigue, joint pain, mood swings and vaginal dryness. To the investigators' knowledge, there are few studies in Norway regarding discontinuation of endocrine treatment in breast cancer. In this study they will investigate the long-term discontinuation pattern to oral adjuvant systemic endocrine therapy in a large cohort of breast cancer patients treated in St. Olav's hospital in Trondheim, Norway, and the association between adherence to endocrine treatment and long-term survival.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Trondheim, Norway
- St Olavs Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Luminal breast cancer
Exclusion Criteria:
Non-Luminal breast cancer
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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breast cancer postoperative
got surgery for breast cancer in St Olavs Hospital, Trondheim, during 2004-2013
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Medication Possession Ratio (MPR) as a proxy for medication adherence
Time Frame: 0-5 years after surgery for breast cancer
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see Detailed description
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0-5 years after surgery for breast cancer
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Survival
Time Frame: 5-14 years after surgery for breast cancer
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Breast cancer specific survival according to adherence and non-adherence
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5-14 years after surgery for breast cancer
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Anne Irene Hagen, md phd, St. Olavs Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/1356
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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