Cognitive Sequelae of Adjuvant Endocrine Therapy for the Treatment of Breast Cancer in Older Women

NCT02480218 | Completed

• 1 other identifier: 130-2015
• Study Type: observational
• Target: 47
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Breast Cancer

Keywords

cognition; tamoxifen; aromatase inhibitors

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year

Study Arms (2)

Tamoxifen

Chemotherapy-naïve women 65 and older with a first diagnosis of early stage HR+ BC, post surgical resection prescribed tamoxifen.

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.

Other: Neuropsychological test battery

Interventions

Neuropsychological test battery OTHER

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.

Aromatase Inhibitors; Tamoxifen

Eligibility Criteria

• Age: 65 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mary C. Tierney, PhD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

• Kathleen Pritchard, MD

  Sunnybrook Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 24, 2015
• Study Start: July 1, 2015
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 5, 2017

Record last verified: 2017-10

Locations

CA (1)