Breast CancerPhase 2NEO ER 11-05NCT01972984
Feasibility Study of Presurgical Hormone Therapy (Anastrozole) in Breast Cancer Patients
A Phase 2 study testing Anastrozole in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Anastrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2012to Aug 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The NEO (NEOADJUVANT ENDOCRINE OUTCOMES) TRIAL: Neoadjuvant Endocrine Therapy for Primary Breast Cancer: Investigation of Clinical and Translational Outcomes
- 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
- Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor.
- 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
- Being tested
- Anastrozole
- Keywords
- Estrogen receptor positive
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnastrozoleDrug
Also called Arimidex
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.
| Study group | Role | What they receive |
|---|---|---|
| Anastrozole | Experimental | All qualifying women will receive anastrozole at the usual dose of 1mg daily for 2-6 weeks leading up to their surgery Receives: Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
All biomarker results will be analyzed at study closure when participant #20 has received surgery.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2013 (estimated)
- Study startOct 2012
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Angel Arnaout, Dr., Principal investigator, The Ottawa Hospital Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01972984
- Sponsor's protocol ID
- 2011712-01H
- Acronym
- NEO ER 11-05
- Status last verified
- Feb 2016
- First submitted
- 26 Sep 2013
- Last updated
- 4 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The NEO (NEOADJUVANT ENDOCRINE OUTCOMES) TRIAL: Neoadjuvant Endocrine Therapy for Primary Breast Cancer: Investigation of Clinical and Translational Outcomes
- ClinicalTrials.gov ID
- NCT01972984
- Acronym / sponsor ID
- NEO ER 11-05 / 2011712-01H
- Conditions
- Breast Cancer
- Keywords
- Estrogen receptor positive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Breast Cancer Foundation
- Study start
- Oct 2012
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 31 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
- Short term anastrozole treatment will induce measurable changes in biomarker levels (ER, PR, Her2, Ki67) within the tumor.
- 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)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anastrozole | Experimental | Drug: AnastrozoleAll qualifying women will receive anastrozole at the usual dose of 1mg daily for 2-6 weeks leading up to their surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnastrozoleAlso: ArimidexParticipants 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. | Drug | Anastrozole |
Primary outcome
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.
1 secondary outcome
Measure the changes in ER, PR, Her2 and Ki67 labelling index on pre- and post treatment tumor tissue
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2016.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angel Arnaout, Dr. principal investigator
The Ottawa Hospital Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anastrozole in people with Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2016.