Trial Outcomes & Findings for Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer (NCT NCT04272801)

NCT ID: NCT04272801

Last Updated: 2025-10-22

Results Overview

Change in participant response to question regarding preference for adjuvant radiation treatment

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 84 participants
• Primary outcome timeframe: up to 6 months
• Results posted on: 2025-10-22

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	84
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Measure	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
Overall Study Withdrawal by Subject	4
Overall Study Lost to Follow-up	4
Overall Study Ineligible	1

Baseline Characteristics

Pre-Operative Window of Adjuvant Endocrine Therapy to Inform RT Decisions in Older Women With Early-Stage Breast Cancer

Baseline characteristics by cohort

Measure	Pre-operative endocrine therapy n=75 Participants 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
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	75 Participants n=5 Participants
Age, Continuous	78.5 years n=5 Participants
Sex: Female, Male Female	75 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	74 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	68 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	75 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 6 months

Change in participant response to question regarding preference for adjuvant radiation treatment

Outcome measures

Measure

Pre-operative endocrine therapy n=75 Participants 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

Number of Participants Who Changed Their Preference for Adjuvant Radiation Treatment

21 Participants

PRIMARY outcome

Timeframe: up to 6 months

Change in surgical oncologist response to question regarding preference for adjuvant radiation treatment

Outcome measures

Measure

Pre-operative endocrine therapy n=75 Participants 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

Change in Surgeon Preference for Adjuvant Radiation Treatment

18 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 24 months after start of adjuvant treatment period

General symptom burden will be assessed using the Breast Cancer Prevention Trial Symptom Checklist.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 24 months after start of adjuvant treatment period

Illness perception will be assessed using the Brief Illness Perception Questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 24 months after start of adjuvant treatment period

Beliefs about medicine will be assessed using the Beliefs about Medicines Questionnaire.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 24 months after start of adjuvant treatment period

Perceived sensitivity to medicine will be assessed using the Perceived Sensitivity to Medicine Scale.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Through 24 months after start of adjuvant treatment period

Depression and anxiety will be assessed using the Center for Epidemiologic Studies Depression Scale Revised.

Outcome measures

Outcome data not reported

Adverse Events

Pre-operative endocrine therapy

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pre-operative endocrine therapy n=75 participants at risk 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
Vascular disorders Pulmonary Embolism	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Vascular disorders Acute Stroke	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.

Other adverse events

Measure	Pre-operative endocrine therapy n=75 participants at risk 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
Psychiatric disorders Agitation	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Investigations Alanine aminotransferase (ALT) Increase	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Skin and subcutaneous tissue disorders Alopecia	12.0% 9/75 • Number of events 9 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Psychiatric disorders Anxiety	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Arthralgia	17.3% 13/75 • Number of events 13 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Arthritis	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Investigations Aspartate aminotransferase (AST) Increase	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Back Pain	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Infections and infestations Bladder Infection	2.7% 2/75 • Number of events 3 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Eye disorders Blurred Vision	2.7% 2/75 • Number of events 2 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Gastrointestinal disorders Constipation	2.7% 2/75 • Number of events 2 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Respiratory, thoracic and mediastinal disorders Cough	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Gastrointestinal disorders Diarrhea	4.0% 3/75 • Number of events 3 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Nervous system disorders Dizziness	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Gastrointestinal disorders Dry Mouth	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Skin and subcutaneous tissue disorders Dry Skin	2.7% 2/75 • Number of events 2 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
General disorders Edema Limbs	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Respiratory, thoracic and mediastinal disorders Epistaxis	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Injury, poisoning and procedural complications Fall	2.7% 2/75 • Number of events 2 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
General disorders Fatigue	17.3% 13/75 • Number of events 14 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
General disorders Fever	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Flank Pain	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
General disorders Flu Like Symptoms	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
General disorders Covid-19	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Psychiatric disorders Insomnia	9.3% 7/75 • Number of events 7 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Nervous system disorders Headaches	8.0% 6/75 • Number of events 6 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Vascular disorders Hot Flashes	29.3% 22/75 • Number of events 22 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Metabolism and nutrition disorders Hypercalcemia	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Metabolism and nutrition disorders Hyperkalemia	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Vascular disorders Hypertension	4.0% 3/75 • Number of events 3 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Investigations Hyperglycemia	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Joint Effusion	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Infections and infestations Lung Infection	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Investigations Lymphocyte Count Increased	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Nervous system disorders Memory Impairment	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Metabolism and nutrition disorders Vitamin D Deficiency	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Gastrointestinal disorders Mucositis Oral	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Muscle Cramp	2.7% 2/75 • Number of events 2 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Neck/Bilateral Arm Pressure	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Knee Pain	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Transient Joint Stiffness	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Myalgia	2.7% 2/75 • Number of events 2 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Gastrointestinal disorders Nausea	6.7% 5/75 • Number of events 5 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Musculoskeletal and connective tissue disorders Pain in Extremity	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Reproductive system and breast disorders Perineal Pain	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Skin and subcutaneous tissue disorders Pruritis	2.7% 2/75 • Number of events 2 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Psychiatric disorders Mood Swings	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Skin and subcutaneous tissue disorders Rash Maculo-Papulr	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Vascular disorders Thromboembolic Event	1.3% 1/75 • Number of events 2 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Nervous system disorders Transient Ischemic Attacks	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Infections and infestations Upper Respiratory Infection	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Renal and urinary disorders Urinary Incontinence	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Infections and infestations Urinary Tract Infection	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Reproductive system and breast disorders Uterine Pain	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Reproductive system and breast disorders Vagina Dryness	2.7% 2/75 • Number of events 2 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Infections and infestations Vaginal Infection	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Reproductive system and breast disorders Vaginal Pain	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Ear and labyrinth disorders Vertigo	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Eye disorders Vision Decrease	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.
Investigations Weight Loss	1.3% 1/75 • Number of events 1 • Adverse events were collected from the date of informed consent through 30 days after the last dose of neo-adjuvant endocrine therapy for non-serious AEs, and through study completion (an average of approximately 27 months) for related SAEs or until initiation of another therapy.

Additional Information

Dr. Shayna Showalter

University of Virginia

Phone: 434-956-8032

Email: snl2t@uvahealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place