Table of Contents
- Clinical trial overview
- Who the trial is for
- Treatments being studied
- What the researchers measured
- Trial status and enrollment
- Key terms explained
Clinical trial overview
The available trial data describe one Phase 1/2 interventional study of Amcenestrant, also listed as SAR439859, in postmenopausal women with estrogen receptor positive advanced breast cancer.[1] The study tested Amcenestrant as a single treatment and also in combination with other anti-cancer therapies.[1]
Who the trial is for
This trial focused on women after menopause, which means they no longer have monthly periods because of natural aging.[1] The cancer type was advanced breast cancer, meaning the disease was not limited to the breast.[1] The trial data do not provide more detailed entry rules, such as age limits or prior treatments.[1]
Treatments being studied
Researchers studied Amcenestrant alone and with several other cancer medicines.[1] The combination partners named in the trial data were palbociclib, alpelisib, everolimus, and abemaciclib.[1] The record also lists branded products used in the study, including Verzenios and IBRANCE, with different tablet or capsule strengths.[1]
The study plan included three parts.[1] In dose escalation, the team increased treatment amounts step by step to find the safest dose and the maximum tolerated dose, which is the highest dose people can take without unacceptable side effects.[1] In the safety run-in, the researchers checked the recommended dose of Amcenestrant with alpelisib.[1] In dose expansion, they looked more closely at how well the treatment worked and at the overall safety profile.[1]
What the researchers measured
The main outcomes were dose-limiting toxicities, objective response rate, and adverse events.[1] Dose-limiting toxicities are serious side effects that can stop a dose from being increased further.[1] Objective response rate means the share of patients whose tumors shrink or disappear during treatment.[1] Adverse events are any unwanted medical problems that happen during the study.[1]
The dose-escalation part aimed to find the recommended dose of Amcenestrant alone and in combination with palbociclib, and also the recommended dose of everolimus or abemaciclib when used with the chosen Amcenestrant dose.[1] The safety run-in aimed to confirm the recommended dose of Amcenestrant with alpelisib.[1] The dose-expansion part looked at antitumor activity through objective response rate and at the overall safety profile of the different combinations.[1]
Trial status and enrollment
The listed study status is Completed.[1] The enrollment number provided in the trial data is 3, which means only three participants were entered in the record shown.[1] Because the enrollment was very small, the trial data mainly describe an early research effort focused on dose and safety questions.[1]
Key terms explained
Interventional study means the researchers give a treatment and then measure what happens.[1] Single agent means a treatment used by itself, not with another medicine.[1] Combination therapy means two or more treatments are given together.[1] Safety profile means the pattern of side effects and other safety findings seen in the study.[1]
Estrogen receptor positive means the cancer has receptors, or binding sites, for estrogen, which can help the cancer grow.[1] Advanced breast cancer means the cancer is more widespread than early-stage disease.[1] Phase 1/2 trials first check safety and dose, then look for early signs of benefit.[1]
