- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01972984
Feasibility Study of Presurgical Hormone Therapy (Anastrozole) in Breast Cancer Patients (NEO ER 11-05)
February 2, 2016 updated by: Ottawa Hospital Research Institute
The NEO (NEOADJUVANT ENDOCRINE OUTCOMES) TRIAL: Neoadjuvant Endocrine Therapy for Primary Breast Cancer: Investigation of Clinical and Translational Outcomes
- Women with operable breast cancer with a 2-8 week preoperative waiting period will accept preoperative therapy trials and specifically taking a standard drug for breast cancer such as anastrozole in this study
- Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor.
- Degree of response to short term anastrozole varies with a) duration of treatment and b) breast cancer subtype (based on initial pre-treatment biomarker status)
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- The Ottawa Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Newly diagnosed postmenopausal women (Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy (with or without hysterectomy) at least six weeks ago.)
- Confirmation of estrogen receptor positive invasive carcinoma on core biopsy
- Patients whose cancers are palpable and have been deemed to be "operable" by the surgeon
- Surgery is planned for the next 2-8 weeks.
Exclusion Criteria:
- History of hormone replacement therapy in the last 6 months
- Previous treatment by tamoxifen or aromatase inhibitor treatment in six months
- Known hypersensitivity or contraindications to aromatase inhibitors
- Known metastatic disease on presentation
- Recurrent breast cancer
- Inability to give informed consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Anastrozole
All qualifying women will receive anastrozole at the usual dose of 1mg daily for 2-6 weeks leading up to their surgery
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Participants will be instructed to take one tablet of anastrozole orally per day with fluids.
This tablet will be taken at the same time every day.
Participants will be given a drug diary to record drug administration and aid in drug compliance.
Should the participant miss a dose they will be asked to record it in their diary and resume the normal dose schedule the next day.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients who fit the eligibility criteria that consent to the study; withdraw after consent from the study.
Time Frame: up to 18 months
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Participants are on study from the time their eligibility is confirmed until the time of their surgery which could be up to 8 weeks.
This is a feasibility study and therefore once the study is closed to accrual the percent of women who signed consent and remained on study until their surgery versus those who withdraw will be determined.
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up to 18 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measure the changes in ER, PR, Her2 and Ki67 labelling index on pre- and post treatment tumor tissue
Time Frame: Up to 18 months
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All biomarker results will be analyzed at study closure when participant #20 has received surgery.
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Up to 18 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Angel Arnaout, Dr., The Ottawa Hospital Cancer Centre
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
September 26, 2013
First Submitted That Met QC Criteria
October 24, 2013
First Posted (Estimate)
October 31, 2013
Study Record Updates
Last Update Posted (Estimate)
February 4, 2016
Last Update Submitted That Met QC Criteria
February 2, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Anastrozole
Other Study ID Numbers
- 2011712-01H
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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The Affiliated Hospital of Qingdao UniversityUnknown
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