Breast cancer?Ovarian cancer?Endometrial cancer?Cervical cancer
Conditions
Interventions
Cold exposure:None
Sponsors
v
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 75 years old; 2.Patients with a histopathologically confirmed diagnosis of any malignant tumor among breast cancer, ovarian cancer, endometrial cancer and cervical cancer, who also have a PIK3CA gene mutation detected in the tumor via genetic testing; 3.Eligible for PI3K inhibitor therapy as assessed by clinical guidelines and medical oncologists, with a plan to initiate or having already initiated monotherapy or combination therapy with PI3K inhibitors (e.g., inavolisib, alpelisib, copanlisib, taselisib, etc.); 4.Expected survival time: >=6 months, with an ECOG performance status score of 0–2; 5.Has the ability to understand the study objectives, procedures and risks, voluntarily signs the informed consent form, and has good compliance to abide by the study protocol, including regular follow-up and treatment monitoring;
Exclusion criteria
Exclusion criteria: 1.Patients with a confirmed diagnosis of any cancer type other than breast, ovarian, endometrial, or cervical cancer, or those with two or more concurrent malignancies; 2.Pregnant or lactating women, and women of childbearing age who are unable to use effective contraception as required; 3.Patients with one of the following conditions before PI3K inhibitor administration: baseline fasting blood glucose >13.9 mmol/L, glycated hemoglobin >9.0%, or a confirmed diagnosis of type 1 or type 2 diabetes; 4.Patients who have previously received PI3K inhibitor therapy and discontinued treatment due to hyperglycemia or other adverse reactions. 5.Patients with a history of severe heart disease (including but not limited to: unstable angina pectoris, myocardial infarction within the past 6 months, congestive heart failure (NYHA Class ?-?), severe cardiac arrhythmia), severe pulmonary disease (including but not limited to: severe chronic obstructive pulmonary disease, interstitial lung disease or pulmonary fibrosis), severe hepatic dysfunction, or severe renal impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;HbA1c;Tumor progression;Liver function;Tumor markers;2-hour postprandial blood glucose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Blood Count;Renal function; | — |
Countries
China
Contacts
Public ContactXiaolei Ni
Longyan First Hospital
Outcome results
None listed