Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tamoxifen (Nolvadex), NOLVADEX
Tamoxifen · 4 trials · 2 indications
The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from calliper measurement). CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by Calliper: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period (based on the data from ultra sound (US) measurement). CR (or PR) criteria are met at 2 or more time in points every 4 weeks. Per RECIST Criteria (V1.0) and assessed by US: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
The BORR were defined as the percentage of patients with confirmed CR or PR in the ITT population during 24 weeks pre-operative treatment period(based on the data from magnetic resonance imaging (MRI) or computed tomography (CT) measurement). CR (or PR) criteria are met at either 12 weeks or 24 weeks. Per RECIST Criteria (V1.0) and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
| Arm | Type | Description |
|---|---|---|
| Group I | EXPERIMENTAL | Tamoxifen alone |
| Group II | EXPERIMENTAL | Tamoxifen + Aminoglutethimide |
| 1 | ACTIVE_COMPARATOR | Tamoxifen |
| 2 | EXPERIMENTAL | Anastrazole (Arimidex) |
| Name | Type | Description |
|---|---|---|
| Tamoxifen alone | DRUG | 2 x 20 mg tamoxifen daily, start of therapy within 4 weeks after surgery; therapy duration 5 years |
| Tamoxifen + Aminoglutethimide | DRUG | 2 x 20 mg tamoxifen daily (5 years) plus Aminoglutethimide daily (first 2 years) * 1st therapy week:125mg/-/125mg Aminoglutethimide daily * 2nd therapy week: 125mg/-/250mg Aminoglutethimid daily * as of 3rd therapy week: 250mg/-/250mg Aminoglutethimid daily |
| Tamoxifen | DRUG | 20 mg once daily oral dose |
| Anastrazole (Arimidex) | DRUG | 1 mg once daily oral dose |
| Goserelin acetate (Zoladex) | DRUG | 3.6mg/month depot injection |
| Anastrozole | DRUG | - |
Inclusion Criteria: * Postmenopausal patients with histologically verified, locoradically treated, invasive or minimally invasive breast cancer * Hormone receptor-positive status * More than 6 histologically examined lymph nodes * Laboratory parameters 1. hematopoiesis: \> 3500/µl leucocytes, \>...
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Tamoxifen is used for the treatment of breast cancer, including early-stage breast cancer. It is an oncology therapy studied in hormone receptor-positive disease, and the clinical program includes biomarker-selected patients. Trials have enrolled premenopausal and postmenopausal women with breast cancer.
Tamoxifen targets ESR1, the estrogen receptor alpha gene. It is classified as a modulator, meaning it acts on estrogen receptor signaling. This target class underlies its use in hormone receptor-positive breast cancer, where the trials enrolled receptor-positive and biomarker-selected patients.
Tamoxifen is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor associated with the drug's clinical development program in breast cancer.
Tamoxifen is in Phase 3 clinical development for breast cancer and early-stage breast cancer. The program includes completed Phase 3 and Phase 2 trials, with no active trials currently listed. It is an investigational small molecule in this development dataset.
Tamoxifen has been studied in completed trials including NCT00605267, a Phase 3 neoadjuvant study in premenopausal breast cancer patients in Japan; NCT00309491, a Phase 3 comparison of Tamoxifen versus Tamoxifen plus aminoglutethimide in postmenopausal receptor-positive patients; NCT00295100, a Phase 2 MRI study; and NCT00291759, the Phase 3 ABCSG 8 adjuvant trial in Austria.
Tamoxifen is also known as Nolvadex. The alternative names associated with this asset include Tamoxifen (Nolvadex) and the combination regimens Tamoxifen + Aminoglutethimide and Tamoxifen+ Aminoglutethimide, which pair Tamoxifen with aminoglutethimide in studied treatment combinations.