Approval Probability
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arzoxifene · 1 trial · 2 indications
The primary endpoint was changed in Ki67 in breast tissue of enrolled patients
| Arm | Type | Description |
|---|---|---|
| Arm I | EXPERIMENTAL | Participants receive oral tamoxifen once daily for 6 months in the absence of disease progression or unacceptable toxicity. After the completion of 6 months of treatment, participants are offered the opportunity to continue treatment for an additional 6 months. |
| Arm II | EXPERIMENTAL | Participants receive oral arzoxifene once daily for 6 months in the absence of disease progression or unacceptable toxicity. After the completion of 6 months of treatment, participants are offered the opportunity to continue treatment for an additional 6 months. |
| Arm III | PLACEBO_COMPARATOR | Participants receive an oral placebo once daily once daily for 6 months in the absence of disease progression or unacceptable toxicity. After the completion of 6 months of treatment, participants are offered treatment with arzoxifene for an additional 6 months. |
| Name | Type | Description |
|---|---|---|
| arzoxifene hydrochloride | DRUG | Given orally |
| tamoxifen citrate | DRUG | Given orally |
| placebo | OTHER | Given orally |
DISEASE CHARACTERISTICS: * Estimated probability of carrying a BRCA1 or BRCA2 mutation ≥ 10% AND meets one of the following criteria: * Participants must have first-degree relatives (FDRs)\* or second-degree relatives (SDRs)\* (with an intervening male relative) with breast or ovarian cancer who...
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Arzoxifene is an investigational small molecule being studied for the prevention of breast cancer in premenopausal women at high risk for the disease, including those with hereditary breast and ovarian cancer linked to BRCA1 or BRCA2 mutations. It is in Phase 2 clinical development and is not approved by the FDA.
Arzoxifene is a selective estrogen receptor modulator, meaning it acts on estrogen receptors. It is being evaluated for its ability to prevent breast cancer in high-risk premenopausal women by modulating estrogen receptor activity.
Arzoxifene is being developed by Community Health Systems, Inc., a company traded on the New York Stock Exchange under the ticker symbol CYH. The drug is currently in Phase 2 clinical development for breast cancer prevention.
Arzoxifene is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 2 clinical trial has been completed, and the drug is not currently in any active trials.
Arzoxifene has been studied in one completed Phase 2 clinical trial, identified as NCT00253539. This trial compared arzoxifene to tamoxifen in preventing breast cancer in premenopausal women at high risk, including those with BRCA1 or BRCA2 mutations. The trial enrolled 3 participants.
No, arzoxifene is not the same as tamoxifen. Arzoxifene is a separate investigational drug being studied as a potential alternative to tamoxifen for breast cancer prevention. In the completed clinical trial, arzoxifene was compared directly against tamoxifen.