Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Camizestrant · 7 trials · 6 indications
TTNT is defined as time from the date of the first administration of study treatment to the earliest start date of subsequent anti-cancer medication or death. The primary measure of interest is the TTNT event-free rate at 2 years.
IBCFS is defined as time from randomisation until date of first occurrence of: * Invasive ipsilateral breast tumour recurrence * Locoregional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer * Death attributable to any cause.
To investigate the safety and tolerability of camizestrant in combination with atirmociclib.
To determine the effect of repeated oral doses of camizestrant on the key PK parameters of a single oral dose of midazolam in healthy postmenopausal female participants.
To determine the effect of repeated oral doses of camizestrant on the key PK parameters of a single oral dose of midazolam in healthy postmenopausal female participants.
To determine the effect of repeated oral doses of camizestrant on the key PK parameters of a single oral dose of midazolam in healthy postmenopausal female participants.
To determine the effect of repeated oral titrated doses of carbamazepine on the PK of a single oral dose of camizestrant in healthy postmenopausal female participants.
To determine the effect of repeated oral titrated doses of carbamazepine on the PK of a single oral dose of camizestrant in healthy postmenopausal female participants.
To determine the effect of repeated oral titrated doses of carbamazepine on the PK of a single oral dose of camizestrant in healthy postmenopausal female participants.
Cmax: maximum concentration
tmax : time to maximum concentration
area under the concentration-time curve (AUC) from zero to the last measurable concentration (AUClast)
area under the concentration-time curve (AUC) from zero to infinity (AUCinf)
tlast: time of the last measurable concentration
t1/2λz: apparent terminal elimination half-life
CL/F: apparent clearance;
Vz/F: apparent volume of distribution.
To assess the effect of Itraconazole on AUCinf of Camizestrant.
To assess the effect of Itraconazole on AUClast of Camizestrant.
To assess the effect of Itraconazole on Cmax of Camizestrant.
| Arm | Type | Description |
|---|---|---|
| Camizestrant and Ribociclib | EXPERIMENTAL | Patients will receive the standard dose of camizestrant and ribociclib once daily as oral tablets |
| Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib | ACTIVE_COMPARATOR | standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) ± abemaciclib |
| Arm B: camizestrant ± abemaciclib | EXPERIMENTAL | camizestrant ± abemaciclib |
| Arm A: standard endocrine therapy of investigator´s choice | ACTIVE_COMPARATOR | Continue standard endocrine therapy of investigator's choice (aromatase inhibitors \[AI; exemestane, letrozole, anastrozole\] or tamoxifen) |
| Arm B: camizestrant | EXPERIMENTAL | Camizestrant |
| Camizestrant + Atirmociclib | EXPERIMENTAL | Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1. |
| Part A: Midazolam + Camizestrant | EXPERIMENTAL | Participants will receive a single oral dose of midazolam on Day 1 in Period 1, followed by oral dose of camizestrant OD from Day 2 to Day 6 in Period 2, and then single oral dose of midazolam with camizestrant on Day 7 with PK sampling on Day 7 to Day 8 in Period 3. |
| Part B: Camizestrant + Carbamazepine | EXPERIMENTAL | Participants will receive a single oral dose of camizestrant on Day 1 with PK sampling on Day 1 to Day 4 in Period 1, followed by low oral doses of carbamazepine BID on Day 4 to Day 6, mid oral doses of carbamazepine BID on Day 7 to Day 9 and high oral doses of carbamazepine BID on Day 10 to Day 15 with single oral dose of camizestrant on Day 13 with PK sampling on Day 16 in Period 2. |
| Group 1 | OTHER | Matched-control healthy participants with normal hepatic function. |
| Group 2 | OTHER | Participants with moderate hepatic impairment (CP Class B, score of 7 to 9). |
| Group 3 | OTHER | Participants with severe hepatic impairment (CP Class C, score of 10 to 15). |
| Treatment Arm | EXPERIMENTAL | Subjects will receive a single oral dose of Camizestrant on Day 1 of treatment period 1. Following washout period of 7 to 10 days, subjects will receive Itraconazole on Days 1, 2, and 3 of treatment period 2, and single oral dose of Camizestrant plus a dose of Itraconazole on Day 1, followed by Itraconazole alone on Day 2 and Day 3 of treatment period 3. |
| Name | Type | Description |
|---|---|---|
| Camizestrant | DRUG | Patients will receive the standard dose of camizestrant once daily as oral tablets |
| Ribociclib | DRUG | Patients will receive the standard dose of ribociclib once daily as oral tablets |
| Tamoxifen | DRUG | Tamoxifen. Comparator. Administered orally |
| Anastrozole | DRUG | Anastrozole. Comparator. Administered orally |
| Letrozole | DRUG | Letrozole. Comparator. Administered orally |
| Exemestane | DRUG | Exemestane. Comparator. Administered orally |
| Abemaciclib | DRUG | Abemaciclib adjuvant treatment Administered orally |
| Atirmociclib | DRUG | Atirmociclib will be administered orally. |
| Midazolam | DRUG | Midazolam will be administered orally. |
| Carbamazepine | DRUG | Carbamazepine will be administered orally. |
| Itraconazole | DRUG | Subjects will be administered Itraconazole twice a day on Day 1 and once daily on Day 2 and Day 3 of treatment period 2, and once daily on Day 1, 2 and 3 of treatment period 3. |
Inclusion Criteria: 1. Capable of giving signed informed consent. 2. Female or male, must be ≥ 18 years or as per locally allowed age limit for screening. Type of Participant and Disease Characteristics 3. Histologically or cytologically documented diagnosis of ER+, HER2- BC based on local labo...
Camizestrant is an investigational oral small molecule being developed for breast cancer, including ER-positive HER2-negative advanced breast cancer, early breast cancer, and advanced breast cancer. It is also studied in healthy subjects and in people with hepatic impairment for pharmacokinetic and safety evaluations. It is not yet approved and remains in clinical development.
Camizestrant is a selective estrogen receptor degrader (SERD), a class of drugs that target the estrogen receptor. It is being studied in ER-positive HER2-negative breast cancer, where it is intended to degrade the estrogen receptor and block estrogen-driven tumor growth.
Camizestrant is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the drug's safety, tolerability, and efficacy in breast cancer and other settings.
Camizestrant is in Phase 2 clinical development for advanced breast cancer, with an additional Phase 3b study recruiting for ER-positive HER2-negative advanced breast cancer. Early Phase 1 studies in healthy subjects and hepatic impairment have been completed. The drug is investigational and not yet approved.
Camizestrant is being studied in several trials, including NCT07427394, a Phase 2 study of camizestrant plus atirmociclib in advanced breast cancer, and NCT07647328, a Phase 3b study of camizestrant plus ribociclib in ER-positive HER2-negative advanced breast cancer. Completed Phase 1 trials include NCT05551897 and NCT05790304.
Yes, Camizestrant is also known as AZD9833. In clinical trial records, the drug is referred to by both names, such as in the study titled 'A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole.'