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Evaluation of Hyperglycemia Using rt-CGM in Patients with HR-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer Treated with Capivasertib

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	HR-Positive, HER2-Negative Recurrent Breast Cancer
Date of first enrollment	28/01/2026
Target sample size	20
Countries of recruitment
Study type	Interventional
Intervention(s)	In this study, the trial will be conducted in two phases: Step 1 and Step 2. <Step 1> Ten patients, which is half of the planned total number of cases, will be recruited for Step 1. The study period will include a 3-day period without capivasertib exposure followed by a 4-week oral administration period, and will be conducted on an outpatient basis. In Step 1, a real-time continuous glucose monitoring system (rt-CGM) will be attached starting 3 days prior to the initiation of capivasertib, and 24-hour continuous glucose data will be collected up to the fourth week after starting the drug. Simultaneously, self-monitoring of blood glucose (SMBG) will be performed from 3 days before the start of capivasertib through the first week of administration. Capivasertib tablets will be administered orally at a dose of 200 mg per tablet, twice daily (after breakfast and dinner). The dosing regimen will consist of 4 consecutive days of administration followed by 3 days off, repeated over a 4-week period (1 cycle). <Step 2> If Step 1 demonstrates the accuracy of rt-CGM in measuring blood glucose levels compared to SMBG under both capivasertib-unexposed and exposed conditions, the remaining 10 patients of the planned total number will be recruited for Step 2. The study period will be 4 weeks (capivasertib administration period), and it will be conducted on an outpatient basis. Starting on the same day as capivasertib administration, rt-CGM will be used to collect 24-hour continuous glucose data until the fourth week after the start of administration. Capivasertib tablets will be administered orally at a dose of 200 mg per tablet, twice daily (after breakfast and dinner), with a regimen of 4 days on followed by 3 days off, repeated over a 4-week period (1 cycle).

Outcome(s)

Primary Outcome

Accuracy of Blood Glucose Measurements by rt-CGM (Dexcom G7) Compared to SMBG in Breast Cancer Patients Receiving Capivasertib The accuracy of blood glucose measurements obtained using real-time continuous glucose monitoring (rt-CGM; Dexcom G7) will be evaluated in comparison with self-monitoring of blood glucose (SMBG) in breast cancer patients receiving Capivasertib under the following two conditions:

Secondary Outcome

Safety of rt-CGM (Dexcom G7) as a Medical Device Time to Detection of Hyperglycemia Time in Range (TIR; time within target glucose range, 70-180 mg/dL) Time Above Range (TAR; time above target glucose range, over 180 mg/dL) Incidence of Diabetic Ketoacidosis (DKA) Progression-Free Survival (PFS) Time to Treatment Failure (TTF)

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 75age old
Gender	Both
Include criteria	1. Patients with breast cancer for whom capivasertib treatment is indicated 2. Patients aged over 18 and under 75 years at the time of enrollment 3. Patients who have provided written informed consent to participate in the study
Exclude criteria	1. Patients with HbA1c over 8% 2. Patients currently taking pralidoxime iodide methyl 3. Pregnant women, women who may be pregnant, or those intending to become pregnant 4. Patients with skin conditions that make it difficult to wear the Dexcom G7 wearable sensor 5. Patients who are unable to use SMBG and rt-CGM appropriately at home or in a similar setting, in accordance with the proper use guidelines 6. Any other patients deemed inappropriate for inclusion in the study by the principal or sub-investigator