Recent Updates
Recently added Catalysts

LY353381

Phase 4

Breast Neoplasms | Small molecule | Oncology |Eli Lilly and Company|Trials Updated: Apr 30, 2015

LY353381 development status

Highest phase Phase 4 (NCT00190697)
Phase scored for LLYPhase 3
Registered trials 6 across 1 sponsor since Apr 2002

LY353381 target and mechanism

ModalitySmall molecule

Also known as Arzoxifene

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials7
Total Enrollment10,080

FDA Designations

No designations recorded

LY353381 clinical trials

LY353381 · 7 trials · 7 indications

Phase 3 4Phase 2 3
NCT00383422Study Comparing Arzoxifene With Raloxifene in Women After Menopause With OsteoporosisOsteoporosis, Postmenopausal
COMPLETED320 Analytics
NCT00088010Effects of Arzoxifene on Bone Fractures and Incidence of Breast CancerOsteoporosis, Postmenopausal
COMPLETED9,369 Analytics
NCT00085956Effects of Arzoxifene on Bone Mass and the UterusPostmenopausal Bone Loss
COMPLETED300 Analytics
NCT00034125Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.Breast Neoplasms
COMPLETED- Analytics
PHASE3COMPLETED
Study Comparing Arzoxifene With Raloxifene in Women After Menopause With Osteoporosis
Osteoporosis, PostmenopausalUnlock trial analytics
PHASE3COMPLETED
Effects of Arzoxifene on Bone Fractures and Incidence of Breast Cancer
Osteoporosis, PostmenopausalUnlock trial analytics
PHASE3COMPLETED
Effects of Arzoxifene on Bone Mass and the Uterus
Postmenopausal Bone LossUnlock trial analytics
PHASE3COMPLETED
Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.
Breast NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Percent change in Lumbar Spine BMD
baseline to 12 months
Effects of arzoxifene on bone fractures and bone mass
5 years
Effects of arzoxifene on getting breast cancer
5 years
The safety of arzoxifene and any side effects
5 years
The effects of arzoxifene on bone mineral density (bone mass) at the spine and hip in postmenopausal women
The effects of arzoxifene on the uterus (womb) in post menopausal women
The safety of arzoxifene and any side effects that might be associated with its use
Lumbar spine bone mineral density (BMD), by dual energy X-ray absorptiometry (DXA) analyses
6 months

Secondary Endpoints

Secondary BMD measures of total hip and femoral neck
at 6 and 12 months
Biochemical markers of bone metabolism assessed
baseline, 3, 6, and 12 months
Assessment of coagulation parameters
baseline, 3, 6, and 12 months
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -

Interventions

NameTypeDescription
ArzoxifeneDRUG20 mg, oral, tablet, once a day for 52 weeks
RaloxifeneDRUG60 mg, oral, tablet, once a day for 52 weeks
PlaceboDRUGoral, tablet, once a day for 36 months
LY353381DRUG -
tamoxifenDRUG -
arzoxifene hydrochlorideDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range50 Years to 75 Years
SexFEMALE
Healthy VolunteersNo
Study Sites21

Inclusion Criteria: * Must have osteoporosis * Must be between 50 and 75 years old and be able to walk * Have at least two of your back bones that can be x-rayed * Have not had a period in at least two years * Be willing to have blood tests Exclusion Criteria: * Have a bone disease other than ost...

Countries:United StatesArgentinaAustraliaCanadaFranceItalySpainTaiwanChileIndiaMexicoSouth Korea
Unlock Eligibility Criteria

Frequently asked questions about LY353381

What is LY353381 used for in breast cancer?

LY353381 is an investigational small molecule being studied for the treatment of breast neoplasms, specifically in women with locally advanced or metastatic breast cancer. It is being developed by Eli Lilly and Company and has completed a Phase 3 clinical trial.

Who makes LY353381?

LY353381 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is an investigational small molecule in the oncology therapeutic area.

What phase is LY353381 in?

LY353381 has completed a Phase 3 clinical trial. The trial, NCT00034125, was a randomized, double-blind study comparing LY353381 to tamoxifen in women with locally advanced or metastatic breast cancer. The drug remains investigational and is not approved.

What clinical trials is LY353381 in?

LY353381 has one completed clinical trial, NCT00034125, a Phase 3 study comparing LY353381 to tamoxifen in women with locally advanced or metastatic breast cancer. The trial was conducted in the United States, Argentina, Chile, India, and Mexico, and enrolled female participants aged 18 years and older.

Is LY353381 FDA approved?

LY353381 is not FDA approved. It is an investigational drug that has completed a Phase 3 clinical trial for breast cancer, but approval status has not been established. The drug remains in clinical development and is not available as a marketed therapy.