Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
anastrazole · 1 trial · 1 indication
PFS was assessed by the investigator based on World Health Organization (WHO) criteria using radiographic tumor evaluations. Disease progression was defined as the appearance of any new lesion not previously identified or an estimated increase of 25% or more in existent bidimensionally or unidimensionally measurable lesions or progression of an existing non-measurable lesion. For bidimensionally measurable malignant lesions with an area of at least 2.0 centimeters squared (cm\^2) an increase of 1.0 cm\^2 was required and for unidimensionally measurable lesions of 1.0 cm or less an increase of 0.5 cm was required. PFS was defined as the number of days between date of randomization and date of documented disease progression or date of death. Kaplan Meier estimates of PFS are presented.
| Arm | Type | Description |
|---|---|---|
| trastuzumab + anastrozole | EXPERIMENTAL | Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase. |
| anastrozole | ACTIVE_COMPARATOR | 1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes. |
| Name | Type | Description |
|---|---|---|
| trastuzumab (Herceptin®) | DRUG | 4mg/kg iv loading dose, followed by 2mg/kg iv weekly |
| anastrazole (Arimidex®) | DRUG | 1 mg tablet taken orally daily |
Inclusion Criteria: * postmenopausal women; * metastatic breast cancer suitable for endocrine therapy; * positive hormone receptor status; * Human epidermal growth factor receptor 2 (HER2) overexpression. Exclusion Criteria: * patients on hormone replacement therapy; * previous chemotherapy for m...
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Anastrozole is an aromatase inhibitor used in the treatment of breast cancer. It is being studied in combination with trastuzumab (Herceptin) compared to anastrozole alone in patients with metastatic breast cancer. The drug is a small molecule developed by Roche Holding AG.
Anastrozole is an aromatase inhibitor, which means it works by inhibiting the aromatase enzyme. This enzyme is involved in the production of estrogen, and by blocking it, anastrozole reduces estrogen levels, which can help slow the growth of hormone-sensitive breast cancer.
Anastrozole is developed by Roche Holding AG, a company traded under the ticker RHHBY. The drug is being investigated for use in breast cancer, specifically in combination with trastuzumab for metastatic breast cancer.
Anastrozole is in Phase 3 clinical development. It is an investigational drug for breast cancer, and it is not yet approved for this indication. The Phase 3 trial has been completed, with 208 patients enrolled.
Anastrozole has been studied in a Phase 3 clinical trial with the identifier NCT00022672. This trial evaluated the efficacy and safety of anastrozole in combination with trastuzumab compared to anastrozole alone in patients with metastatic breast cancer. The trial has been completed.
Yes, anastrozole is the same as Arimidex. In the clinical trial NCT00022672, anastrozole is referred to as Arimidex, which is a brand name for the drug. The trial compares the combination of Herceptin (trastuzumab) with Arimidex (anastrozole) to Arimidex alone.