Breast CancerNCT02480218
Cognitive Sequelae of Adjuvant Endocrine Therapy for the Treatment of Breast Cancer in Older Women
An observational study of Breast Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Breast cancer is the most frequently diagnosed cancer in women with the majority receiving an endocrine therapy (ET) in the adjuvant setting. ETs dramatically reduce recurrence and improve survival but given the aging population and increased survivorship, there are growing concerns regarding the cognitive effects of… Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Neuropsychological test battery
- How many people
- 47 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to Jun 2017
- Phase
- Observational
- 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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: chemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection, who are prescribed either tamoxifen, anastrozole or letrozole.
Who may be able to join
- Postmenopausal female, age 65 and older
- No more than 14 weeks post surgical resection for early stage histologically confirmed hormone receptor positive (HR+) breast cancer (BC) (i.e., Tumour size 1-2, Node status 0-1, Metastasis 0). HR+ BC defined as >1% positive cell staining
- Prescribed either tamoxifen, letrozole, or anastrozole
- Fluent in written and spoken English; >grade 5 education; can read large print (with or without correction); can hear normal conversation (with or without a hearing aid)
- Capacity to provide informed consent
Who cannot join
- Initiated adjuvant ET more than one week before baseline assessment
- Chemotherapy (neoadjuvant or adjuvant)
- More than one treatment of radiotherapy before baseline assessment
- Hormone replacement therapy use 4 weeks prior to baseline assessment
- Previous breast cancer or metastatic disease or other malignancy, other than any cancers treated for cure >5 years ago and not having recurred except non-melanoma skin cancers; previous chemotherapy; previous use of selective estrogen receptor modulators (SERM) or aromatase inhibitor (AI); distant metastases
- History of or active known CNS disease (e.g. known diagnosis of stroke, Parkinson's), medical condition impairing cognitive function, including active treatment with medication known to affect cognition, or signs of cognitive impairment on the Memory Impairment Screen
- History or active known diagnosis of major psychiatric disorder in the last 10 years including bipolar disease, schizophrenia, major depression or self-reported hospitalization for psychiatric illness, alcoholism, or history of alcohol or drug abuse
- Life expectancy less than two years, acutely ill or delirious
Trial locations and contacts
1 site in 1 country.
About this study
Breast cancer is the most frequently diagnosed cancer in women with the majority receiving an endocrine therapy (ET) in the adjuvant setting. ETs dramatically reduce recurrence and improve survival but given the aging population and increased survivorship, there are growing concerns regarding the cognitive effects of ETs since estrogen is neuroprotective. A critical unanswered question is whether there are differences in cognitive decline between the two classes of ETs, selective estrogen receptor modulators (SERMs - tamoxifen) and aromatase inhibitors (letrozole and anastrozole), in older women at greater risk of hormone receptor breast cancer and cognitive decline. Before a large multicentre observational study can be undertaken the investigators are proposing a feasibility study to establish metrics on participation, retention and adherence rates and parameter estimates to inform sample size calculation required to detect cognitive differences between the two ET classes. A convenience sample of chemotherapy-naïve patients, aged 65 and older, with early stage disease, 25 on a SERM and 50 on an aromatase inhibitor, will be assessed cognitively at baseline and after one year.
Read the detailed description
The convenience sample will consist of chemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection, who are prescribed either TAM (n=25) or an AI, anastrozole or letrozole (n=50). Based on a survey of medical oncologist prescribing practices at Sunnybrook, the investigators will be able to obtain sufficient numbers for the convenience sample from the pool of 220 older women with BC referred annually to medical and radiation oncology at the Louise Temerty Breast Cancer Clinic and the Odette Cancer Centre . The investigators will recruit consecutively seen eligible patients before radiotherapy. Experienced clinical trial staff will identify eligible patients from the clinic list of each medical and radiation oncologist, who will then introduce the study during the visit. The Research Coordinator (RC) will meet with interested patients for consent to conduct the screening assessment for signs of cognitive impairment using the Memory Impairment Screen (MIS), a sensitive and reliable tool. The MIS will take no more than 5 minutes and will be conducted in a private room at either the Louise Temerty Breast Cancer Centre or the Odette Cancer Centre depending on the location of the patient's appointment. The RC will then obtain consent from all those who pass the MIS to participate in the study and arrange for testing. The RC will administer the assessment battery at a time convenient to the patient, before radiotherapy. Drug adherence rates will be obtained using monthly telephone self-reports. After 1 year, participants will undergo the same testing protocol as at baseline using alternate forms where possible. The RC will document how many continue to meet study criteria including changes in health status, medications, etc. The investigators do not expect any major selection biases between our groups. While exclusion of women co-administered chemotherapy due to its confounding effects on cognition may bias the sample by including more women with co-morbidities, this potential bias should be reduced by our exclusion of previous cancers, life expectancy <2 years, and central nervous system (CNS) disorders. To determine bias in attrition of women at year 1 due to cognitive impairment, the investigators will contact all participants and caregivers who do not return to determine the reason.
- Conditions
- Breast Cancer
- Being tested
- Neuropsychological test battery
- Keywords
- cognition, tamoxifen, aromatase inhibitors
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological test batteryOther
Participants will have been prescribed their endocrine therapy for the treatment of breast cancer prior to enrollment. Neuropsychological test batteries will be administered at baseline and at one-year follow-up to assess changes in cognition.
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Chemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection prescribed tamoxifen. Receives: Other: Neuropsychological test battery | |
| Aromatase Inhibitors | Chemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection prescribed aromatase inhibitors. Receives: Other: Neuropsychological test battery |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who experience cognitive impairment after 1 year of treatment
Cognitive impairment will be defined as scoring at or below -1.5 standard deviations from the normative mean on two or more tests, or as scoring at or below -2.0 standard deviations on a single test.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017
- Study completionJun 2017
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 Sunnybrook Health Sciences CentreThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary C. Tierney, PhD, Principal investigator, Sunnybrook Health Sciences CentreKathleen Pritchard, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480218
- Sponsor's protocol ID
- 130-2015
- Status last verified
- Oct 2017
- First submitted
- 11 Jun 2015
- Last updated
- 5 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Sequelae of Adjuvant Endocrine Therapy for the Treatment of Breast Cancer in Older Women
- ClinicalTrials.gov ID
- NCT02480218
- Acronym / sponsor ID
- 130-2015
- Conditions
- Breast Cancer
- Keywords
- cognition, tamoxifen, aromatase inhibitors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 24 Jun 2015 (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.
Breast cancer is the most frequently diagnosed cancer in women with the majority receiving an endocrine therapy (ET) in the adjuvant setting. ETs dramatically reduce recurrence and improve survival but given the aging population and increased survivorship, there are growing concerns regarding the cognitive effects of ETs since estrogen is neuroprotective. A critical unanswered question is whether there are differences in cognitive decline between the two classes of ETs, selective estrogen receptor modulators (SERMs - tamoxifen) and aromatase inhibitors (letrozole and anastrozole), in older women at greater risk of hormone receptor breast cancer and cognitive decline. Before a large multicentre observational study can be undertaken the investigators are proposing a feasibility study to establish metrics on participation, retention and adherence rates and parameter estimates to inform sample size calculation required to detect cognitive differences between the two ET classes. A convenience sample of chemotherapy-naïve patients, aged 65 and older, with early stage disease, 25 on a SERM and 50 on an aromatase inhibitor, will be assessed cognitively at baseline and after one year.
Detailed description
The convenience sample will consist of chemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection, who are prescribed either TAM (n=25) or an AI, anastrozole or letrozole (n=50). Based on a survey of medical oncologist prescribing practices at Sunnybrook, the investigators will be able to obtain sufficient numbers for the convenience sample from the pool of 220 older women with BC referred annually to medical and radiation oncology at the Louise Temerty Breast Cancer Clinic and the Odette Cancer Centre . The investigators will recruit consecutively seen eligible patients before radiotherapy. Experienced clinical trial staff will identify eligible patients from the clinic list of each medical and radiation oncologist, who will then introduce the study during the visit. The Research Coordinator (RC) will meet with interested patients for consent to conduct the screening assessment for signs of cognitive impairment using the Memory Impairment Screen (MIS), a sensitive and reliable tool. The MIS will take no more than 5 minutes and will be conducted in a private room at either the Louise Temerty Breast Cancer Centre or the Odette Cancer Centre depending on the location of the patient's appointment. The RC will then obtain consent from all those who pass the MIS to participate in the study and arrange for testing. The RC will administer the assessment battery at a time convenient to the patient, before radiotherapy. Drug adherence rates will be obtained using monthly telephone self-reports. After 1 year, participants will undergo the same testing protocol as at baseline using alternate forms where possible. The RC will document how many continue to meet study criteria including changes in health status, medications, etc. The investigators do not expect any major selection biases between our groups. While exclusion of women co-administered chemotherapy due to its confounding effects on cognition may bias the sample by including more women with co-morbidities, this potential bias should be reduced by our exclusion of previous cancers, life expectancy <2 years, and central nervous system (CNS) disorders. To determine bias in attrition of women at year 1 due to cognitive impairment, the investigators will contact all participants and caregivers who do not return to determine the reason.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen | – | Other: Neuropsychological test batteryChemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection prescribed tamoxifen. |
| Aromatase Inhibitors | – | Other: Neuropsychological test batteryChemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection prescribed aromatase inhibitors. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- chemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection, who are prescribed either tamoxifen, anastrozole or letrozole.
Key inclusion criteria (5 listed)
- Postmenopausal female, age 65 and older
- No more than 14 weeks post surgical resection for early stage histologically confirmed hormone receptor positive (HR+) breast cancer (BC) (i.e., Tumour size 1-2, Node status 0-1, Metastasis 0). HR+ BC defined as >1% positive cell staining
- Prescribed either tamoxifen, letrozole, or anastrozole
- Fluent in written and spoken English; >grade 5 education; can read large print (with or without correction); can hear normal conversation (with or without a hearing aid)
- Capacity to provide informed consent
Key exclusion criteria (8 listed)
- Initiated adjuvant ET more than one week before baseline assessment
- Chemotherapy (neoadjuvant or adjuvant)
- More than one treatment of radiotherapy before baseline assessment
- Hormone replacement therapy use 4 weeks prior to baseline assessment
- Previous breast cancer or metastatic disease or other malignancy, other than any cancers treated for cure >5 years ago and not having recurred except non-melanoma skin cancers; previous chemotherapy; previous use of selective estrogen receptor modulators (SERM) or aromatase inhibitor (AI); distant metastases
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 |
|---|---|---|
| Neuropsychological test batteryParticipants will have been prescribed their endocrine therapy for the treatment of breast cancer prior to enrollment. Neuropsychological test batteries will be administered at baseline and at one-year follow-up to assess changes in cognition. | Other | Aromatase Inhibitors, Tamoxifen |
Primary outcome
The proportion of patients who experience cognitive impairment after 1 year of treatment
Time frame: 1 year
Cognitive impairment will be defined as scoring at or below -1.5 standard deviations from the normative mean on two or more tests, or as scoring at or below -2.0 standard deviations on a single test.
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 5 Oct 2017.
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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.
Mary C. Tierney, PhD principal investigator
Sunnybrook Health Sciences Centre
Kathleen Pritchard, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Sunnybrook Health Sciences Centre 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 5 inclusion and 8 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 5 Oct 2017. 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.
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?
The proportion of patients who experience cognitive impairment after 1 year of treatment (time frame: 1 year). 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 5 Oct 2017; AzTrials last refreshed its copy on 7 Nov 2026.