Feasibility Study of Presurgical Hormone Therapy (Anastrozole) in Breast Cancer Patients

Breast Cancer Clinical Trial

— NEO ER 11-05  

Official title:

The NEO (NEOADJUVANT ENDOCRINE OUTCOMES) TRIAL: Neoadjuvant Endocrine Therapy for Primary Breast Cancer: Investigation of Clinical and Translational Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972984
• Other study ID #: 2011712-01H
• Status: Completed
• Phase: Phase 2
• First received: September 26, 2013
• Last updated: February 2, 2016
• Start date: October 2012
• Est. completion date: August 2014

Study information

• Verified date: February 2016
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

1. 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

2. Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor.

3. 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.)

2. Confirmation of estrogen receptor positive invasive carcinoma on core biopsy

3. Patients whose cancers are palpable and have been deemed to be "operable" by the surgeon

4. Surgery is planned for the next 2-8 weeks.

Exclusion Criteria:

1. History of hormone replacement therapy in the last 6 months

2. Previous treatment by tamoxifen or aromatase inhibitor treatment in six months

3. Known hypersensitivity or contraindications to aromatase inhibitors

4. Known metastatic disease on presentation

5. Recurrent breast cancer

6. Inability to give informed consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole
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.

Locations

Country	Name	City	State
Canada	The Ottawa Hospital	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Canadian Breast Cancer Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients who fit the eligibility criteria that consent to the study; withdraw after consent from the study.	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.	up to 18 months	No
Secondary	Measure the changes in ER, PR, Her2 and Ki67 labelling index on pre- and post treatment tumor tissue	All biomarker results will be analyzed at study closure when participant #20 has received surgery.	Up to 18 months	No