Feasibility Study of Presurgical Hormone Therapy (Anastrozole) in Breast Cancer Patients (NEO ER 11-05)
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|ClinicalTrials.gov Identifier: NCT01972984|
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : February 4, 2016
- 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)
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Anastrozole||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The NEO (NEOADJUVANT ENDOCRINE OUTCOMES) TRIAL: Neoadjuvant Endocrine Therapy for Primary Breast Cancer: Investigation of Clinical and Translational Outcomes|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
All qualifying women will receive anastrozole at the usual dose of 1mg daily for 2-6 weeks leading up to their surgery
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 Name: Arimidex
- 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 ]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.
- Measure the changes in ER, PR, Her2 and Ki67 labelling index on pre- and post treatment tumor tissue [ Time Frame: Up to 18 months ]All biomarker results will be analyzed at study closure when participant #20 has received surgery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972984
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Principal Investigator:||Angel Arnaout, Dr.||The Ottawa Hospital Cancer Centre|