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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anastrozole

• Registration Number: NCT01972984
• Lead Sponsor: Ottawa Hospital Research Institute

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-09-26
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-31
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-02
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anastrozole	Anastrozole	All qualifying women will receive anastrozole at the usual dose of 1mg daily for 2-6 weeks leading up to their surgery

Primary Outcome Measures

Name	Time	Method
Percentage of patients who fit the eligibility criteria that consent to the study; withdraw after consent from the study.	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.

Secondary Outcome Measures

Name	Time	Method
Measure the changes in ER, PR, Her2 and Ki67 labelling index on pre- and post treatment tumor tissue	Up to 18 months	All biomarker results will be analyzed at study closure when participant #20 has received surgery.

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada