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

Exploring a Novel Approach to Identifying Hyperglycemia: Real-Time Continuous Glucose Monitoring (rt-CGM) in Patients Receiving Capivasertib for Hormone Receptor-Positive, HER2-Negative Breast Cancer

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042250167

Enrollment

Registered

2026-01-22

Start date

2026-01-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HR-Positive, HER2-Negative Recurrent Breast Cancer HR-Positive, HER2-Negative, Metastatic, Recurrent, Breast Cancer,Capivasertib

Interventions

In this study, the trial will be conducted in two phases: Step 1 and Step 2. Ten patients, which is half of the planned total number of cases, will be recruited for Step 1. The study period will incl

rt-CGM,DEXCOMG7,SMBG

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
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:	—

Measure

Time frame

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

Measure	Time frame
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)	—

Contacts

Public ContactDaigaku Nakamura

Nagoya City University Hospital

phmhori@med.nagoya-cu.ac.jp+81-52-851-5511

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026