Breast Cancer Female
Conditions
Keywords
breast cancer, endocrine therapy, radiation, letrozole, anastrozole, exemestane, tamoxifen, survey, questionnaire, geriatric
Brief summary
This is a prospective multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated with 3 months of pre-operative endocrine therapy (pre-ET) with assessment of tolerance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).
Detailed description
This single arm pilot study evaluates the use of pre-operative endocrine therapy in women with early stage ER+ breast cancer who are 65 years or older and are scheduled to have breast conservation surgery (BCS). The purpose of this study is to see if tolerance of pre-operative endocrine therapy helps inform decisions on whether or not to omit radiation. Participants will be treated with the novel approach of 3 months of pre-operative endocrine therapy, so that the participants and providers will have some indication of tolerance prior to making a decision about radiation omission. Tolerance of the endocrine therapy will be assessed by patient reported outcome (PRO) measures during neoadjuvant and adjuvant endocrine therapy treatment periods. Breast cancer participants and their surgical oncologists will be asked their preference regarding radiation therapy before starting endocrine therapy and again pre-operatively. They will make a determination regarding radiation therapy as per standard care. The hypothesis is that knowledge of tolerance of endocrine therapy will influence the decision by the patient and the surgical oncologist whether or not to elect radiation omission.
Interventions
choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist
BEHAVIORALPatient reported outcomes
Questionnaire inquiries include the following: * how cancer affects daily living * beliefs about medicines and sensitivity to medicine * symptoms * adherence to endocrine therapy * general health and well being * depression and anxiety * preference regarding radiation therapy
Sponsors
National Cancer Institute (NCI)
Shayna Showalter, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Pilot, 1 arm
Eligibility
Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(Summary): * ECOG performance status 0-2 * Diagnosed with anatomic stage I, ER positive, PR positive or negative, and HER2 non amplified invasive breast cancer and clinically negative nodes; any invasive breast cancer histologic subtype may be enrolled * Tumor size ≤ 2 cm * Patient has elected BCS as surgical choice * Eligible to receive tamoxifen or an aromatase inhibitor * Ability to take oral medication and be willing to adhere to the endocrine therapy for the 3 month period prior to BCS
Exclusion criteria
(Summary): * Prior or current use of endocrine therapy for breast cancer * History of ipsilateral breast radiation * Pregnancy or lactation * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. * Current or planned use of a strong CYP2D6 inhibitor (e.g. Fluoxetine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment | up to 6 months | Change in participant response to question regarding preference for adjuvant radiation treatment |
| Change in Surgeon Preference for Adjuvant Radiation Treatment | up to 6 months | Change in surgical oncologist response to question regarding preference for adjuvant radiation treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Illness Perception as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS | Through 24 months after start of adjuvant treatment period | Illness perception will be assessed using the Brief Illness Perception Questionnaire. |
| Beliefs About Medicine as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS | Through 24 months after start of adjuvant treatment period | Beliefs about medicine will be assessed using the Beliefs about Medicines Questionnaire. |
| Perceived Sensitivity to Medicine as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS | Through 24 months after start of adjuvant treatment period | Perceived sensitivity to medicine will be assessed using the Perceived Sensitivity to Medicine Scale. |
| Health Related Quality of Life Surveys as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS | Through 24 months after start of adjuvant treatment period | Health related quality of life will be assessed using the EORTC QLQ-C30 and QLQ-BR23. |
| Treatment Decision as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS. | up to 90 days after surgery, chemotherapy completion, or RT completion, whichever is later | Treatment decision will be assessed using the Treatment Decision Survey, a novel series of questions regarding why subjects decide to have or not to have radiation therapy, and why or why not to restart endocrine therapy. |
| Perceptions Related to Medical Choices as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS. | Through 24 months after start of adjuvant treatment period | Subjects' perceptions related to their medical choices will be assessed using the Decisional Conflict Scale and the Decision Regret Scale. |
| Depression and Anxiety as Predictive Measure for Endocrine Therapy Adherence | Through 24 months after start of adjuvant treatment period | Depression and anxiety will be assessed using the Center for Epidemiologic Studies Depression Scale Revised. |
| Breast Cancer Beliefs as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS | Through 24 months after start of adjuvant treatment period | Breast cancer beliefs will be assessed using the UVA Breast Cancer Belief Survey, a novel series of questions regarding patient beliefs about breast cancer and breast cancer medications. |
| General Symptom Burden as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS | Through 24 months after start of adjuvant treatment period | General symptom burden will be assessed using the Breast Cancer Prevention Trial Symptom Checklist. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pre-operative endocrine therapy All participants enrolled to the study will receive 3 months of pre-operative endocrine therapy (e.g. tamoxifen or aromatase inhibitors (AIs) such as letrozole, anastrozole, or exemestane). The choice and dose of endocrine therapy will be at the discretion of the treating medical oncologist.
tamoxifen, letrozole, anastrozole, or exemestane: choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist
Patient reported outcomes: Questionnaire inquiries include the following:
* how cancer affects daily living
* beliefs about medicines and sensitivity to medicine
* symptoms
* adherence to endocrine therapy
* general health and well being
* depression and anxiety
* preference regarding radiation therapy | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Ineligible | 1 |
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Pre-operative endocrine therapy |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 75 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 78.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 68 Participants |
| Region of Enrollment United States | 75 Participants |
| Sex: Female, Male Female | 75 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 75 |
| other Total, other adverse events | 35 / 75 |
| serious Total, serious adverse events | 2 / 75 |
Outcome results
Primary
Change in Surgeon Preference for Adjuvant Radiation Treatment
Change in surgical oncologist response to question regarding preference for adjuvant radiation treatment
Time frame: up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative endocrine therapy | Change in Surgeon Preference for Adjuvant Radiation Treatment | 18 Participants |
Primary
Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment
Change in participant response to question regarding preference for adjuvant radiation treatment
Time frame: up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-operative endocrine therapy | Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment | 21 Participants |
Secondary
Beliefs About Medicine as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS
Beliefs about medicine will be assessed using the Beliefs about Medicines Questionnaire.
Time frame: Through 24 months after start of adjuvant treatment period
Secondary
Breast Cancer Beliefs as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS
Breast cancer beliefs will be assessed using the UVA Breast Cancer Belief Survey, a novel series of questions regarding patient beliefs about breast cancer and breast cancer medications.
Time frame: Through 24 months after start of adjuvant treatment period
Secondary
Depression and Anxiety as Predictive Measure for Endocrine Therapy Adherence
Depression and anxiety will be assessed using the Center for Epidemiologic Studies Depression Scale Revised.
Time frame: Through 24 months after start of adjuvant treatment period
Secondary
General Symptom Burden as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS
General symptom burden will be assessed using the Breast Cancer Prevention Trial Symptom Checklist.
Time frame: Through 24 months after start of adjuvant treatment period
Secondary
Health Related Quality of Life Surveys as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS
Health related quality of life will be assessed using the EORTC QLQ-C30 and QLQ-BR23.
Time frame: Through 24 months after start of adjuvant treatment period
Secondary
Illness Perception as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS
Illness perception will be assessed using the Brief Illness Perception Questionnaire.
Time frame: Through 24 months after start of adjuvant treatment period
Secondary
Perceived Sensitivity to Medicine as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS
Perceived sensitivity to medicine will be assessed using the Perceived Sensitivity to Medicine Scale.
Time frame: Through 24 months after start of adjuvant treatment period
Secondary
Perceptions Related to Medical Choices as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS.
Subjects' perceptions related to their medical choices will be assessed using the Decisional Conflict Scale and the Decision Regret Scale.
Time frame: Through 24 months after start of adjuvant treatment period
Secondary
Treatment Decision as Predictive Measure for Endocrine Therapy Adherence and to Assess Effect of Pre-ET on Decision Outcomes for Adjuvant Therapy After BCS.
Treatment decision will be assessed using the Treatment Decision Survey, a novel series of questions regarding why subjects decide to have or not to have radiation therapy, and why or why not to restart endocrine therapy.
Time frame: up to 90 days after surgery, chemotherapy completion, or RT completion, whichever is later