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OpenTrials
Completed

NCT Number: NCT01972984

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

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)

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: Arimidex

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

  • Canadian Breast Cancer Foundation

Registry information

Official study title

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

Acronym: NEO ER 11-05

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 31, 2013
Registry last updated
Feb 4, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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