Breast Cancer SurvivorsNCT02122107
Cognition in Older Breast Cancer Survivors: Treatment Exposure, APOE and Smoking History
An observational study of Breast Cancer Survivors, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
In this study,the investigators are looking to see how older women who are survivors of breast cancer and either did or did not receive chemotherapy are affected by treatment, compared to older women who have never had cancer. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Survivors
- How many people
- 499 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2014to Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: We propose to enroll 540 participants into the study across the 2 sites: 270 participants (approximately 180 patients and 90 controls) from MSK and 270 participants from City of Hope (approximately 180 patients, and 90 controls).
Who may be able to join
- The neuropsychological assessments were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the tests. Friend nominated, non-cancer controls will be frequency matched on age (+/- 5 years), education (less than college vs. some college and above), and race will be recruited using the same eligibility criteria as survivors except for no history of cancer.
- For cancer patients, eligibility includes:
- As per medical record or self-report, post-menopausal female
- As per medical record or self-report, age 60 or older at recruitment
- As per medical record or self-report, age 55 or older at the time of breast cancer diagnosis
- As per medical record or self report, for cancers other than breast cancer or non-melanoma/basal cell skin cancer/squamous cell skin cancer:
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- Patient must be at least 3 years post diagnosis of that cancer
- Not received chemotherapy treatment or external beam radiation for that cancer
- As per medical record or self-report, 5-15 years post diagnosis of breast cancer at the time of enrollment
- As per medical record or self-report, no evidence of any cancer disease
- American Joint Committee on Cancer (AJCC) stages 0-III breast cancer survivor as per clinical judgment/electronic medical record (EMR)
- Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
- English proficiency verified through an adapted Bidimensional acculturation scale, score of 2.5 or above ***The scale will only be administered to participants who report also speaking a language other than English.
- For controls participants, eligibility includes:
- As per medical record or self-report, post-menopausal female
- As per medical record or self-report, age 60 and older at recruitment
- In the judgment of the consenting professional, able to communicate well enough in English through verbal and written communication to complete the study assessments and provide informed consent
- °English proficiency verified through an adapted Bidimensional acculturation scale, score of 2.5 or above. The scale will only be administered to participants who report also speaking a language other than English.
- Score of < 11 on the Blessed Orientation-Memory-Concentration Test (BOMC)
- As per self report, no history of treatment with chemotherapy
- As per self report no history of cancer except non-melanoma/basal cell skin cancer squamous cell skin carcinoma
Who cannot join
- For cancer patients, exclusion criteria includes:
- As per medical record or self report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g., Alzheimer's, Parkinson's, Multiple Sclerosis, dementia, seizure disorders, etc)
- As per medical record or self report, history of stroke or head injury requiring visit to the emergency room or hospitalization
- As per medical record or self report, diagnosis of major Axis I psychiatric disorder including schizophrenia, manic-depressive disorder, or substance use disorders
- As per self report or in the judgment of the consenting professional, visual or auditory impairment that would preclude ability to complete assessments
- As per self report or as confirmed by the medical record, if the patient is taking anti-depression or anti-anxiety medication, < 2 months on these medication or a change in the prescribed dose in the past 2 months
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- Previously or actively participating in protocol MSK IRB# 10-079
- For control participants, exclusion criteria include
- As per self report, diagnosis of neurodegenerative disorder that affects cognitive function (e.g., Alzheimer's, Parkinson's, Multiple Sclerosis, dementia, seizure disorders, etc.)
- As per self report, history of stroke or head injury requiring visit to the emergency room or hospitalization
- As per self report, diagnosis of major Axis I psychiatric disorder including schizophrenia, manic-depressive disorder, or substance use disorder
- As per self report, or in the judgment of the consenting professional, visual or auditory impairment that would preclude ability to complete assessments
- As per self report,if the person is taking anti-anxiety or anit-depression medication <2 months on these medications or a change in the prescribed dose in the past 2 months
- Previously or actively participating in protocol 10-079
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope
Duarte, California, 91010
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
In this study,the investigators are looking to see how older women who are survivors of breast cancer and either did or did not receive chemotherapy are affected by treatment, compared to older women who have never had cancer. Thinking and memory abilities normally decrease with age and the investigators want to see if the long-term effects of cancer treatments may make these problems worse. The investigators will also look at how thinking and memory abilities of older women are affected by genetics and smoking history. Genetics and other factors may affect the brain's chemicals or structure, and may either protect against the negative effects on thinking or make someone more at risk for them.
MSK participants who previously consented to allostatic blood and saliva collection but have not yet provided any allostatic blood or saliva samples for this study, will not be asked to provide any further samples at follow-up. Participants who have consented to allostatic sample collection and provided one set of allostatic blood and saliva samples at a previous follow-up study visit will still be asked to provide a second set of samples at a later follow-up. COH participants will continue to provide allostatic blood and saliva collection as originally outlined
- Conditions
- Breast Cancer Survivors
- Keywords
- Treatment Exposure, Smoking History, 14-071
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breast cancer survivors who had received chemotherapy | Participants will complete all assessments at enrollment and approximately (+/- 16 weeks) at 8, 16, and 24 month follow-ups. We will screen participants to ensure that 50% of each group will report no smoking history and 50% will report a smoking history. Blood or buccal samples will be collected by trained staff one time at baseline. Those who choose not to provide the blood samples will be asked to provide a buccal sample as an alternative to test for APOE polymorphisms. Both patients and controls alive/deceased status will be tracked. | |
| breast cancer survivors who had not received chemotherapy | Participants will complete all assessments at enrollment and approximately (+/- 16 weeks) at 8, 16, and 24 month follow-ups. We will screen participants to ensure that 50% of each group will report no smoking history and 50% will report a smoking history. Blood or buccal samples will be collected by trained staff one time at baseline. Those who choose not to provide the blood samples will be asked to provide a buccal sample as an alternative to test for APOE polymorphisms. Both patients and controls alive/deceased status will be tracked. | |
| non-cancer controls matched by age,education, and race | Participants will complete all assessments at enrollment and approximately (+/- 16 weeks) at 8, 16, and 24 month follow-ups. We will screen participants to ensure that 50% of each group will report no smoking history and 50% will report a smoking history. Blood or buccal samples will be collected by trained staff one time at baseline. Those who choose not to provide the blood samples will be asked to provide a buccal sample as an alternative to test for APOE polymorphisms. Both patients and controls alive/deceased status will be tracked. |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurocognitive outcomes
Neurocognitive tests will be performed longitudinally at 4 time points, enrollment, and 8, 16, and 24 months post enrollment.The participant will also be asked to complete two surveys.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study start8 Apr 2014
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- City of Hope Medical Center, The New School for Social Research
- Responsible party
- Sponsor
- Investigators
- James Root, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122107
- Sponsor's protocol ID
- 14-071
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2014
- Last updated
- 4 Feb 2026
- Results posted
- No
Publications
Daniel E, Deng F, Patel SK, Sedrak MS, Kim H, Razavi M, Sun CL, Root JC, Ahles TA, Dale W, Chen BT. Brain white matter microstructural changes in chemotherapy-treated older long-term breast cancer survivors. Cancer Med. 2024 Jan;13(1):e6881. doi: 10.1002/cam4.6881. Epub 2023 Dec 28.
PubMed 38152038
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognition in Older Breast Cancer Survivors: Treatment Exposure, APOE and Smoking History
- ClinicalTrials.gov ID
- NCT02122107
- Acronym / sponsor ID
- 14-071
- Conditions
- Breast Cancer Survivors
- Keywords
- Treatment Exposure, Smoking History, 14-071
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- City of Hope Medical Center, The New School for Social Research
- Study start
- 8 Apr 2014 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 24 Apr 2014 (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.
In this study,the investigators are looking to see how older women who are survivors of breast cancer and either did or did not receive chemotherapy are affected by treatment, compared to older women who have never had cancer. Thinking and memory abilities normally decrease with age and the investigators want to see if the long-term effects of cancer treatments may make these problems worse. The investigators will also look at how thinking and memory abilities of older women are affected by genetics and smoking history. Genetics and other factors may affect the brain's chemicals or structure, and may either protect against the negative effects on thinking or make someone more at risk for them.
MSK participants who previously consented to allostatic blood and saliva collection but have not yet provided any allostatic blood or saliva samples for this study, will not be asked to provide any further samples at follow-up. Participants who have consented to allostatic sample collection and provided one set of allostatic blood and saliva samples at a previous follow-up study visit will still be asked to provide a second set of samples at a later follow-up. COH participants will continue to provide allostatic blood and saliva collection as originally outlined
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| breast cancer survivors who had received chemotherapy | – | –Participants will complete all assessments at enrollment and approximately (+/- 16 weeks) at 8, 16, and 24 month follow-ups. We will screen participants to ensure that 50% of each group will report no smoking history and 50% will report a smoking history. Blood or buccal samples will be collected by trained staff one time at baseline. Those who choose not to provide the blood samples will be asked to provide a buccal sample as an alternative to test for APOE polymorphisms. Both patients and controls alive/deceased status will be tracked. |
| breast cancer survivors who had not received chemotherapy | – | –Participants will complete all assessments at enrollment and approximately (+/- 16 weeks) at 8, 16, and 24 month follow-ups. We will screen participants to ensure that 50% of each group will report no smoking history and 50% will report a smoking history. Blood or buccal samples will be collected by trained staff one time at baseline. Those who choose not to provide the blood samples will be asked to provide a buccal sample as an alternative to test for APOE polymorphisms. Both patients and controls alive/deceased status will be tracked. |
| non-cancer controls matched by age,education, and race | – | –Participants will complete all assessments at enrollment and approximately (+/- 16 weeks) at 8, 16, and 24 month follow-ups. We will screen participants to ensure that 50% of each group will report no smoking history and 50% will report a smoking history. Blood or buccal samples will be collected by trained staff one time at baseline. Those who choose not to provide the blood samples will be asked to provide a buccal sample as an alternative to test for APOE polymorphisms. Both patients and controls alive/deceased status will be tracked. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We propose to enroll 540 participants into the study across the 2 sites: 270 participants (approximately 180 patients and 90 controls) from MSK and 270 participants from City of Hope (approximately 180 patients, and 90 controls).
Key inclusion criteria (22 listed)
- The neuropsychological assessments were designed and validated in English and are not currently available in other languages. Translation of questionnaires into other languages would require reestablishing the reliability and validity of these measures. Therefore, participants must be able to communicate in English to complete the tests. Friend nominated, non-cancer controls will be frequency matched on age (+/- 5 years), education (less than college vs. some college and above), and race will be recruited using the same eligibility criteria as survivors except for no history of cancer.
- As per medical record or self-report, post-menopausal female
- As per medical record or self-report, age 60 or older at recruitment
- As per medical record or self-report, age 55 or older at the time of breast cancer diagnosis
- As per medical record or self report, for cancers other than breast cancer or non-melanoma/basal cell skin cancer/squamous cell skin cancer:
Key exclusion criteria (14 listed)
- For cancer patients, exclusion criteria includes:
- For control participants, exclusion criteria include
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
neurocognitive outcomes
Time frame: up to 24 months
Neurocognitive tests will be performed longitudinally at 4 time points, enrollment, and 8, 16, and 24 months post enrollment.The participant will also be asked to complete two surveys.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 38152038Daniel E, Deng F, Patel SK, Sedrak MS, Kim H, Razavi M, Sun CL, Root JC, Ahles TA, Dale W, Chen BT. Brain white matter microstructural changes in chemotherapy-treated older long-term breast cancer survivors. Cancer Med. 2024 Jan;13(1):e6881. doi: 10.1002/cam4.6881. Epub 2023 Dec 28.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
James Root, PhD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites 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 Survivors, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
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 22 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
neurocognitive outcomes (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02122107, which also lists 1 linked publication.
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 2026.