Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication EXEMESTANE is an aromatase inhibitor indicated for: • adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to EXEMESTANE for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). FDA label
Also known as exemestane (Aromasin®), Aromasin
Exemestane · 7 trials · 2 indications
Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).
Overall survival in months measured from date of starting treatment in core study to date of death for any reason.
Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
DFS defined as time from randomization to earliest documentation of breast cancer relapse or death from any cause. DFS at Month 36 post-randomization was defined as probability of participants alive and disease-free at 36 months after the randomization. Participants withdrawn from the study for any reason in the absence of relapse were censored at the date they were last seen. Relapse was categorized as follows: loco-regional: ipsilateral breast or axillary nodal relapse; distant: distant relapse, including supraclavicular nodes; second primary breast cancer: contralateral breast cancer, excluding ductal carcinoma in situ.
Clinical benefit was based on objective tumor assessments made according to Response Evaluation Criteria (RECIST) system of unidimensional evaluation. Includes subjects with complete response (CR), partial response (PR), and long term disease stabilization (SD) for at least 24 weeks.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| exemestane | EXPERIMENTAL | - |
| tamoxifen + exemestane | EXPERIMENTAL | - |
| 1. | ACTIVE_COMPARATOR | - |
| 2. | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| exemestane | DRUG | take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal |
| anastrozole | DRUG | take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal |
| tamoxifen | DRUG | Two tablets of tamoxifen 10 mg per day during 2.5 to 3 years followed by one tablet of exemestane 25 mg per day during 2 to 2.5 years for a total duration of 5 years of treatment |
| Megestrol acetate | DRUG | Megestrol Acetate 160 mg oral tablets Qd |
| exemestane (Aromasin) | DRUG | exemestane (Aromasin) 25 mg oral tablets Qd |
| tamoxifen + exemestane | DRUG | tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy |
| Celecoxib + Exemestane | DRUG | Exemestane + celecoxib treatment arm, she will be instructed to take also two x 200 mg celecoxib capsules twice a day, every day, with food. |
| exemestane (Aromasin®) | DRUG | - |
Inclusion Criteria: * Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer. Exclusion Criteria: * Having received any hormonal therapy (e.g., Tamoxifen, LHRH-a...
Exemestane is used to treat breast neoplasms, including metastatic breast cancer. It is studied in postmenopausal women as adjuvant therapy for non-metastatic breast cancer, as neoadjuvant treatment for operable breast cancer, and as initial hormonal therapy for advanced or recurrent breast cancer.
Exemestane targets CYP19A1 and acts as an inhibitor. By inhibiting this target, it belongs to the aromatase inhibitor class of small molecule oncology agents used in hormone-sensitive breast cancer settings.
Exemestane is developed by Pfizer, Inc., which trades under the ticker PFE. The drug is also known by the brand name Aromasin.
Yes. Exemestane is marketed under the brand name Aromasin, so exemestane and Aromasin refer to the same medicine. Searches for Aromasin, exemestane (Aromasin), or exemestane (Aromasin®) all point to this same small molecule aromatase inhibitor.
Exemestane has been studied in Phase 3 clinical development for breast cancer indications. Its trial record includes six completed studies, with no active trials currently listed, and a combined enrollment of 24,753 participants across randomized, double-blind, active-controlled designs.
Completed exemestane trials include NCT01237327, a Phase 3 follow-up study in metastatic breast cancer in China, NCT00279448, a Phase 3 adjuvant study in non-metastatic breast cancer in France, and NCT00143390, a Phase 3 comparison with Arimidex in advanced or recurrent breast cancer in Japan.