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NEO ER 11-05: Feasibility Study of Presurgical Hormone Therapy (Anastrozole) in Breast Cancer Patients

Sponsor
Ottawa Hospital Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT01972984
Collaborator
Canadian Breast Cancer Foundation (Other)
20
Enrollment
1
Location
1
Arm
22
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The NEO (NEOADJUVANT ENDOCRINE OUTCOMES) TRIAL: Neoadjuvant Endocrine Therapy for Primary Breast Cancer: Investigation of Clinical and Translational Outcomes
Study Start Date :
Oct 1, 2012
Actual Primary Completion Date :
Aug 1, 2014
Actual Study Completion Date :
Aug 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Anastrozole

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

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.
Other Names:
  • Arimidex

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Ottawa Hospital Ottawa Ontario Canada K1H 8L6

    Sponsors and Collaborators

    • Ottawa Hospital Research Institute
    • Canadian Breast Cancer Foundation

    Investigators

    • Principal Investigator: Angel Arnaout, Dr., The Ottawa Hospital Cancer Centre

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ottawa Hospital Research Institute
    ClinicalTrials.gov Identifier:
    NCT01972984
    Other Study ID Numbers:
    • 2011712-01H
    First Posted:
    Oct 31, 2013
    Last Update Posted:
    Feb 4, 2016
    Last Verified:
    Feb 1, 2016
    Keywords provided by Ottawa Hospital Research Institute
    Estrogen receptor positive
    Additional relevant MeSH terms:
    Breast Neoplasms
    Anastrozole

    Study Results

    No Results Posted as of Feb 4, 2016