## Protocol Section
### Identification Module
**NCT ID:** NCT00005879

**Brief Title:** LY353381 in Preventing Breast Cancer in Women With Hyperplasia

**Official Title:** A Phase II Clinical Trial of a Selective Estrogen Receptor Modulator (LY353381*HCl) in High Risk Women With Fine Needle Aspiration Cytologic Evidence of Hyperplasia

#### Organization Study ID Info
**ID:** KUMC-HSC-7264-97
#### Organization
**Class:** OTHER
**Full Name:** University of Kansas Medical Center
#### Secondary ID Infos
**Domain:** PDQ (Physician Data Query)
**ID:** CDR0000067918
**Type:** REGISTRY
**Domain:** NCI
**ID:** NCI-P00-0146
**Type:** OTHER
**ID:** U01CA077165
**Link:** https://reporter.nih.gov/quickSearch/U01CA077165
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2008-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-07

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-05-30

**Type:** ACTUAL

**Results First Submit Date:** 2017-01-23

**Results First Submit QC Date:** 2017-04-19

#### Start Date
**Date:** 2000-08

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2003-01-27
**Type:** ESTIMATED
**Study First Submit Date:** 2000-06-02
**Study First Submit QC Date:** 2003-01-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Kansas Medical Center

#### Responsible Party

**Investigator Affiliation:** University of Kansas Medical Center

**Investigator Full Name:** Carol Fabian, MD

**Investigator Title:** Director, Breast Cancer Prevention Unit

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of LY353381 may be an effective way to prevent the development of breast cancer in women who have hyperplasia.

PURPOSE: Randomized phase II trial to study the effectiveness of LY353381 in preventing breast cancer in women who have hyperplasia.

**Detailed Description:** OBJECTIVES:

* Determine if LY353381 hydrochloride improves baseline cytology in women at high risk for breast cancer.
* Determine if this drug modulates other potential surrogate endpoint biomarkers or drug effect biomarkers.
* Determine if cytologic improvement is associated with initial presentation of the various stratification factors.
* Determine whether cytology is correlated with other potential surrogate endpoint biomarkers or drug effect biomarkers and whether change in cytology is correlated with change in the other biomarkers.
* Monitor the effects of this drug in terms of quality of life and women's health.

OUTLINE: This is a randomized, double-blind, multicenter study followed by an open-label study for both arms. Patients are stratified according to cytologic status (hyperplasia with atypia vs hyperplasia without atypia), mutation status (known carrier for BRCA1 or BRCA2 genes vs known not to be a carrier of mutant genes), menopausal status (premenopausal vs postmenopausal), estrogen-receptor status, and participating center. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive oral LY353381 hydrochloride once daily for 6 months.
* Arm II: Patients receive oral placebo once daily for 6 months. Patients in both arms then receive oral LY353381 hydrochloride for an additional 6 months.

Quality of life is assessed at baseline and then at 6 and 12 months.

Patients are followed at 2 weeks and then annually for 5 years.

PROJECTED ACCRUAL: A total of 210-220 patients will be accrued for this study within 2.5-3 years.

### Conditions Module

**Conditions:**

- Breast Cancer

**Keywords:**

- breast cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 199

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Placebo

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

#### Arm Group 2

**Description:** LY353381, 20 mg daily

**Intervention Names:**

- Drug: arzoxifene

**Label:** Arzoxifene

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Arzoxifene

**Description:** one tablet daily

**Name:** arzoxifene

**Other Names:**

- LY353381

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** matched tablet dialy

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Change in the semi-quantitative score assigned by the designated cytopathologist.

Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.

**Measure:** Change in Masood Score

**Time Frame:** Baseline to 6 months

**Description:** Change (improvement) in categorical descriptor of cytologic abnormality as assigned by the primary cytopathologist.

Categories include: normal (non-proliferative), epithelial hyperplasia, epithelial hyperplasia with atypia.

**Measure:** Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months

**Time Frame:** Baseline to 6 months

### Eligibility Module

**Eligibility Criteria:** DISEASE CHARACTERISTICS:

* Current random fine needle breast aspiration (FNA) evidence of 1 of the following:

  * Hyperplasia with atypia
  * Hyperplasia without atypia but with a 10-year modified Gail risk of at least 4%
  * Hyperplasia without atypia but with a BRCAPRO risk of at least 25%
  * Hyperplasia without atypia but with a known mutation in BRCA1 or BRCA2
  * Hyperplasia without atypia but with a history of contralateral ductal carcinoma in situ or invasive breast cancer
* FNA must have been taken during days 1-14 of the menstrual cycle for premenopausal women
* Classified as ACR class I-III on mammogram with stepwedge within past 6 months If intact uterus and/or ovaries, must have color doppler transvaginal pelvic sonogram within past 6 months showing endometrial thickening no greater than 13 mm premenopausal or no greater than 8 mm postmenopausal

  * No ovarian cysts felt to be possibly or probably non-physiologic that have not resolved to gynecologist's satisfaction on repeat sonogram
* Must agree to have or have had genetic counseling and genetic testing performed for BRCA1 and BRCA2
* No active cancer (e.g., detectable disease)
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Female

Menopausal status:

* Any

Performance status:

* Not specified

Life expectancy:

* At least 12 months

Hematopoietic:

* Hemoglobin greater than 10 g/dL
* Granulocyte count greater than 1,000/mm\^3
* No deficiencies in protein C, protein S, or antithrombin III
* No activated protein C resistance

Hepatic:

* Albumin greater than 3.0 g/dL
* Bilirubin less than 1.5 mg/dL
* AST less than 100 U/L
* Alkaline phosphatase less than 200 U/L

Renal:

* Creatinine less than 1.5 mg/dL

Cardiovascular:

* No history of deep venous thrombosis not related to trauma or pregnancy
* No severe coronary artery disease
* No history of prior stroke

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 3 months after study
* No other active cancer
* No retinal vein thrombosis
* No concurrent severe poorly controlled migraine
* No factor V Leiden mutation carrier

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 12 months since prior immunotherapy

Chemotherapy:

* At least 3 months between completion of prior KUMC phase II difluoromethylornithine (DFMO) study and baseline aspiration
* At least 12 months since prior chemotherapy

Endocrine therapy:

* Must not have started or stopped hormone replacement therapy or oral contraceptives within 6 months of baseline aspiration
* Must continue all hormone replacement therapy and/or oral contraceptives that were being taken at time of baseline aspiration
* At least 12 months since prior tamoxifen, raloxifene, or other antihormonal therapy

Radiotherapy:

* At least 3 months since prior radiotherapy

Surgery:

* At least 6 months between prior oophorectomy and baseline aspiration

Other:

* At least 2 weeks since the start of other new medication that would be ingested for 1 or more months

**Healthy Volunteers:** True

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Kansas City

**Country:** United States

**Facility:** University of Kansas Medical Center

**State:** Kansas

**Zip:** 66160-7820

**Location 2:**

**City:** Dallas

**Country:** United States

**Facility:** U.S. Oncology Research, Inc.

**State:** Texas

**Zip:** 75246

#### Overall Officials

**Official 1:**

**Affiliation:** University of Kansas

**Name:** Carol J. Fabian, MD

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**Description:** Global results will be published.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M10016

- Name: Hyperplasia

- Relevance: HIGH

- As Found: Hyperplasia

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000006965

- Term: Hyperplasia

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M8116

- Name: Estrogens

- Relevance: LOW

- As Found: Unknown

- ID: M22599

- Name: Estrogen Receptor Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M22597

- Name: Selective Estrogen Receptor Modulators

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Placebo

**Description:** Placebo

Placebo: matched tablet dialy

**ID:** EG000

**Other Num Affected:** 100

**Other Num at Risk:** 101

**Serious Number Affected:** 5

**Serious Number At Risk:** 101

**Title:** Placebo

**Group ID:** EG001

**Title:** Arzoxifene

**Description:** LY353381, 20 mg daily

arzoxifene: one tablet daily

**ID:** EG001

**Other Num Affected:** 97

**Other Num at Risk:** 98

**Serious Number Affected:** 9

**Serious Number At Risk:** 98

**Title:** Arzoxifene

**Frequency Threshold:** 5

#### Other Events

**Term:** Asthenia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Fatigue

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vasodilation

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Notes:** Hot flashes

**Organ System:** General disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Leg Cramps

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Sweating

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Metrorrhagia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Urinary Frequency

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** CTCAE (3.0)

**Term:** Vaginitis

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

#### Serious Events

**Term:** APPENDICITIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 101

**Num Events:** 2

**Group ID:** EG001

**Num At Risk:** 98

**Term:** SLIPPED DISK

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 101

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 98

**Num Events:** 1

**Term:** OVARIAN CYST

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 101

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 98

**Num Events:** 1

**Term:** ISCHEMIC COLITIS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 101

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 98

**Term:** UTERINE DISORDER / MULTIPLE UTERINE FIBROIDS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 101

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 98

**Num Events:** 1

**Term:** ANGIOEDEMA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 101

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 98

**Num Events:** 1

**Term:** DEEP VEIN THROMBOSIS RIGHT CALF

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Vascular disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 101

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 98

**Term:** RIGHT BIMALLEOLAR ANKLE FRACTURE

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 101

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 98

**Num Events:** 1

**Term:** BILATERAL CATARACTS

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Eye disorders

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 101

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 98

**Num Events:** 1

**Term:** ACUTE MYELOID LEUKEMIA

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 101

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 98

**Num Events:** 1

**Term:** BREAST CANCER

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 101

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 98

**Num Events:** 1

**Term:** PRIMARY DCIS IN BREAST

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Neoplasms benign, malignant and unspecified (incl cysts and polyps)

**Source Vocabulary:** CTCAE (3.0)

##### Stats

**Group ID:** EG000

**Num At Risk:** 101

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 98

**Num Events:** 1

**Time Frame:** Duration on study agent, nominally a maximum of 12 months.

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 101

**Group ID:** BG001

**Value:** 98

**Group ID:** BG002

**Value:** 199

**Units:** Participants

### Group

**ID:** BG000

**Title:** Placebo

**Description:** Placebo

Placebo: matched tablet dialy

### Group

**ID:** BG001

**Title:** Arzoxifene

**Description:** LY353381, 20 mg daily

arzoxifene: one tablet daily

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 7.1

**Value:** 46.5

#### Measurement

**Group ID:** BG001

**Spread:** 6.6

**Value:** 46.7

#### Measurement

**Group ID:** BG002

**Spread:** 6.9

**Value:** 46.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 101

#### Measurement

**Group ID:** BG001

**Value:** 98

#### Measurement

**Group ID:** BG002

**Value:** 199

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 101

#### Measurement

**Group ID:** BG001

**Value:** 98

#### Measurement

**Group ID:** BG002

**Value:** 199

**Class Title:** United States

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 2.6

**Value:** 64.8

#### Measurement

**Group ID:** BG001

**Spread:** 2.4

**Value:** 65.1

#### Measurement

**Group ID:** BG002

**Spread:** 2.5

**Value:** 65.0

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 32

**Value:** 156

#### Measurement

**Group ID:** BG001

**Spread:** 40

**Value:** 157

#### Measurement

**Group ID:** BG002

**Spread:** 36

**Value:** 156

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 5.5

**Value:** 26.3

#### Measurement

**Group ID:** BG001

**Spread:** 5.8

**Value:** 26.0

#### Measurement

**Group ID:** BG002

**Spread:** 5.6

**Value:** 26.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 52

#### Measurement

**Group ID:** BG001

**Value:** 51

#### Measurement

**Group ID:** BG002

**Value:** 103

**Category Title:** Pre

#### Measurement

**Group ID:** BG000

**Value:** 49

#### Measurement

**Group ID:** BG001

**Value:** 47

#### Measurement

**Group ID:** BG002

**Value:** 96

**Category Title:** Post

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 66

#### Measurement

**Group ID:** BG001

**Value:** 69

#### Measurement

**Group ID:** BG002

**Value:** 135

**Category Title:** None

#### Measurement

**Group ID:** BG000

**Value:** 35

#### Measurement

**Group ID:** BG001

**Value:** 29

#### Measurement

**Group ID:** BG002

**Value:** 64

**Category Title:** OC or HRT Use

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 1.42

**Value:** 12.78

#### Measurement

**Group ID:** BG001

**Spread:** 1.45

**Value:** 12.82

#### Measurement

**Group ID:** BG002

**Spread:** 1.43

**Value:** 12.79

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.4

**Value:** 20.6

#### Measurement

**Group ID:** BG001

**Spread:** 12.1

**Value:** 20.2

#### Measurement

**Group ID:** BG002

**Spread:** 11.2

**Value:** 20.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 17

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 34

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 27

#### Measurement

**Group ID:** BG002

**Value:** 50

**Class Title:** 0 Relatives

#### Measurement

**Group ID:** BG000

**Value:** 53

#### Measurement

**Group ID:** BG001

**Value:** 52

#### Measurement

**Group ID:** BG002

**Value:** 105

**Class Title:** 1 Relative

#### Measurement

**Group ID:** BG000

**Value:** 23

#### Measurement

**Group ID:** BG001

**Value:** 17

#### Measurement

**Group ID:** BG002

**Value:** 40

**Class Title:** 2 Relatives

#### Measurement

**Group ID:** BG000

**Value:** 2

#### Measurement

**Group ID:** BG001

**Value:** 2

#### Measurement

**Group ID:** BG002

**Value:** 4

**Class Title:** 3 Relatives

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
### Measure 4
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Height
**Unit of Measure:** inches
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Weight
**Unit of Measure:** lb
### Measure 6
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** BMI
**Unit of Measure:** kg/m^2
### Measure 7
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Menopause Status
**Unit of Measure:** Participants
### Measure 8
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Hormone Use
**Unit of Measure:** Participants
### Measure 9
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age at Menarche
**Unit of Measure:** years
### Measure 10
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age at First Live Birth
**Unit of Measure:** years
### Measure 11
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Prior Biopsy
**Unit of Measure:** Participants
### Measure 12
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Number relatives with Breast Cancer
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** bkimler@kumc.edu
**Organization:** University of Kansas Medical Center
**Phone:** 913-588-4523
**Title:** Bruce F. Kimler, Ph.D.
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.9
- **Upper Limit:** 
- **Value:** -1.1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** -0.8
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 53
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 52
**Title:** No Improvement
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 31
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 30
**Title:** Improvement
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Change in the semi-quantitative score assigned by the designated cytopathologist.

Range 6-24. Score represents increasing abnormality (i.e., worse appearance) Sum composite of 6 cytomorphological features, each scored as 1-4.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Analysis is restricted to subjects that complete the initial 6-month portion of the trial, have a repeat random periareolar fine needle aspiration, and are thus evaluable for change in Masood score.
**Reporting Status:** POSTED
**Time Frame:** Baseline to 6 months
**Title:** Change in Masood Score
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### Group
**Description:** Placebo

Placebo: matched tablet dialy
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** LY353381, 20 mg daily

arzoxifene: one tablet daily
**ID:** OG001
**Title:** Arzoxifene
#### Outcome Measure 2
**Description:** Change (improvement) in categorical descriptor of cytologic abnormality as assigned by the primary cytopathologist.

Categories include: normal (non-proliferative), epithelial hyperplasia, epithelial hyperplasia with atypia.
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Population Description:** Analysis is restricted to subjects that complete the initial 6-month portion of the trial, have a repeat random periareolar fine needle aspiration, and are thus evaluable for change in cytomorphology category.
**Reporting Status:** POSTED
**Time Frame:** Baseline to 6 months
**Title:** Number of Participants With Improvement From Baseline in Cytomorphologic Abnormality at 6 Months
**Type:** PRIMARY
**Unit of Measure:** Participants
##### Group
**Description:** Placebo

Placebo: matched tablet dialy
**ID:** OG000
**Title:** Placebo
##### Group
**Description:** LY353381, 20 mg daily

arzoxifene: one tablet daily
**ID:** OG001
**Title:** Arzoxifene
### Participant Flow Module
#### Group
**Description:** Placebo

Placebo: matched tablet dialy
**ID:** FG000
**Title:** Placebo
#### Group
**Description:** LY353381, 20 mg daily

arzoxifene: one tablet daily
**ID:** FG001
**Title:** Arzoxifene
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 8
###### Reason
**Group ID:** FG001
**Number of Subjects:** 10
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 101
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 98
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 93
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 88
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
**Recruitment Details:** Screen by random periareolar fine needle aspiration for presence of hyperplasia or hyperplasia with atypia.
**Has Results:** True