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

NCT ID: NCT01972984

Last Updated: 2016-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-08-31

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)

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anastrozole

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

Group Type: EXPERIMENTAL

Anastrozole

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Arimidex

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian Breast Cancer Foundation

OTHER

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angel Arnaout, Dr.

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital Cancer Centre

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

2011712-01H

Identifier Type: -

Identifier Source: org_study_id