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

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ClinicalTrials.gov Identifier: NCT01972984
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : February 4, 2016
Sponsor:
Collaborator:
Canadian Breast Cancer Foundation
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Anastrozole Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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 : October 2012
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Anastrozole

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 Name: Arimidex




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972984


Locations
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Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Sponsors and Collaborators
Ottawa Hospital Research Institute
Canadian Breast Cancer Foundation
Investigators
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Principal Investigator: Angel Arnaout, Dr. The Ottawa Hospital Cancer Centre

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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01972984     History of Changes
Other Study ID Numbers: 2011712-01H
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Keywords provided by Ottawa Hospital Research Institute:
Estrogen receptor positive
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs