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

NCT01972984 | Completed Phase 2 DMC

• 1 other identifier: 2011712-01H
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor.
3. 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

Keywords

Estrogen receptor positive

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Measure the changes in ER, PR, Her2 and Ki67 labelling index on pre- and post treatment tumor tissue

  Up to 18 months

Study Arms (1)

Anastrozole

EXPERIMENTAL

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

Drug: Anastrozole

Interventions

Anastrozole 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.

Also known as: Arimidex

Anastrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Breast Cancer Foundation: collaborator

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Angel Arnaout, Dr.

  The Ottawa Hospital Cancer Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2013
• First Posted: October 31, 2013
• Study Start: October 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: February 4, 2016

Record last verified: 2016-02

Locations

CA (1)