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Patient reported outcomes for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Breast CancerPatient reported outcomes - Behavioral
Eligibility
65+
Female
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Study Summary

This trial is testing whether pre-operative endocrine therapy helps inform decisions on whether or not to omit radiation for elderly women with early stage breast cancer scheduled for breast conservation surgery.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
LOXO-783
1
Accelerated Partial Breast Irradiation (APBI)
1
Tamoxifen

Study Objectives

2 Primary · 15 Secondary · Reporting Duration: Through 24 months after start of adjuvant treatment period

Month 6
Beliefs about medicine as predictive measure for endocrine therapy adherence
Breast
General symptom burden as predictive measure for endocrine therapy adherence
Health related quality of life surveys as predictive measure for endocrine therapy adherence
Illness perception as predictive measure for endocrine therapy adherence
Perceived sensitivity to medicine as predictive measure for endocrine therapy adherence
Month 24
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
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
Depression and anxiety as predictive measure for endocrine therapy adherence
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
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
Illness perception 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 as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS
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.
up to 6 months
Change in participant preference for adjuvant radiation treatment
Change in surgeon preference for adjuvant radiation treatment
Day 90
Treatment decision as predictive measure for endocrine therapy adherence and to assess effect of pre-ET on decision outcomes for adjuvant therapy after BCS.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
LOXO-783
2
Accelerated Partial Breast Irradiation (APBI)
2
Tamoxifen

Trial Design

2 Treatment Groups

Neoadjuvant endocrine therapy
1 of 2
Pre-operative endocrine therapy
1 of 2

Experimental Treatment

83 Total Participants · 2 Treatment Groups

Primary Treatment: Patient reported outcomes · No Placebo Group · Phase 2

Neoadjuvant endocrine therapyExperimental Group · 2 Interventions: tamoxifen, letrozole, anastrozole, or exemestane, Patient reported outcomes · Intervention Types: Drug, Behavioral
Pre-operative endocrine therapyExperimental Group · 2 Interventions: tamoxifen, letrozole, anastrozole, or exemestane, Patient reported outcomes · Intervention Types: Drug, Behavioral

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through 24 months after start of adjuvant treatment period

Who is running the clinical trial?

Trish Millard, MDLead Sponsor
Shayna Showalter, MDLead Sponsor
2 Previous Clinical Trials
386 Total Patients Enrolled
2 Trials studying Breast Cancer
386 Patients Enrolled for Breast Cancer
Shayna L Showalter, MDPrincipal InvestigatorUniversity of Virginia

Eligibility Criteria

Age 65+ · Female Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Women with hormone receptor positive breast cancer who are eligible to receive tamoxifen or an aromatase inhibitor and have the ability to take oral medication are eligible for BCS
An individual with an ECOG performance status of 0-2 is considered to have a good performance status.
Women with invasive breast cancer who have been diagnosed with stage I disease, ER positive or negative, PR positive or negative, and who have no evidence of lymph node metastasis may be eligible to participate in this study.
The tumor is ≤ 2 cm in size.
The patient has decided to have breast conserving surgery.
References

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