Breast cancer
Conditions
Interventions
Control group:placebo
Metformin group:metfromin
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: Breast cancer 1) Age: 18-45 years old; 2) Molecular typing of breast cancer: ER(-)PR(-)HER-2(-) or HER-2(+); 3) Breast cancer staging: patients receiving adjuvant/neoadjuvant chemotherapy in stage I-IIIa; 4) Assessment of normal ovarian function before chemotherapy (regular menstruation 2 months before chemotherapy); 5) Sign the informed consent form. Cervical cancer 1) age: 18-45 years old; 2) Preoperative pathological diagnosis of cervical squamous cell carcinoma, cervical adenosquamous carcinoma or cervical adenocarcinoma; 3) Clinical diagnosis is IB2 (with fertility requirements), IB3 and IIA2; 4) retain one or both sides or part of the ovaries; 5) normal ovarian function before chemotherapy (regular menstruation 2 months before chemotherapy); Sign the informed consent form. Ovarian cancer: inclusion criteria: 1) age: 18-45 years old; 2) Pathological diagnosis is limited to unilateral ovarian epithelial cancer; malignant germ cell tumor (unlimited staging); IC stage stromal stromal cell tumor; 3) retain one or both sides or part of the ovaries; 4) need to receive chemotherapy; 5) Estimated survival period: more than 2 years; ECOG score is 0-1 points; 6) normal ovarian function before chemotherapy (regular menstruation 2 months before chemotherapy); 7) Sign the informed consent form. Ovarian cancer 1) Patients aged 18-45 years old; 2) Pathological diagnosis is limited to unilateral ovarian epithelial cancer; malignant germ cell tumor (unlimited staging); IC stage stromal stromal cell tumor; 3) retain one or both sides or part of the ovaries; 4) Who receive chemotherapy; 5) Estimated survival period: more than 2 years; ECOG score is 0-1 points; 6) Normal ovarian function before chemotherapy (regular menstruation 2 months before chemotherapy); 7) Sign the informed consent form.? Trophoblastic tumors 1)age: 18-45 years old; 2) Clinical diagnosis of aggressive hydatidiform mole and choriocarcinoma (FIGO prognostic score >= 7 points, high-risk type), placental site trophoblastic tumor (PSTT) surgery to preserve ovarian patients, high risk factors (mitotic index > 5 / 10 HPF ; > 2 years from the previous pregnancy; deep infiltration, necrosis), patients with chemotherapy with EMA-Co regimen; 3) Erosive hydatidiform mole and choriocarcinoma (FIGO prognostic score <7, low-risk type), single-agent MTX chemotherapy showed drug resistance, and patients were treated with EMA-CO regimen; 4) Assessment of normal ovarian function before chemotherapy (regular menstruation 2 months before chemotherapy); 5) Sign the informed consent form.
Exclusion criteria
Exclusion criteria: Breast cancer exclusion criteria 1) Previously received chemotherapy and pelvic area radiotherapy 2) combined with endocrine diseases affecting ovarian function (such as PCOS hyperprolactinemia, hyperandremia, adrenal dysfunction, etc.); 3) Combine cardiovascular, liver, kidney, infectious diseases, hematopoietic system and other serious diseases, with a history of lactic acidosis or high risk factors; 4) distant metastasis of breast cancer; 5) pregnant or lactating women; 6) A history of diabetes is currently taking any hypoglycemic agent; 7) known to be allergic to metformin hydrochloride and its analogues; 8) Patients who are participating in or have participated in other clinical trials in the past 3 months; 9) oral contraceptives or hormonal drugs during the trial; 10) Other patients identified by the investigator as unfit for the study; Refusal of follow-up request. Cervical cancer exclusion criteria: 1) Those who have previously received chemotherapy and pelvic area radiotherapy; 2) Combine endocrine diseases (such as PCOS, hyperprolactinemia, hyperandremia, adrenal dysfunction, etc.) that affect ovarian function; 3) Combine cardiovascular, liver, kidney, infectious diseases, hematopoietic system and other serious diseases, with a history of lactic acidosis or high risk factors; 4) distant metastasis of cervical cancer; 5) pregnant or lactating women; 6) A history of diabetes is currently taking any hypoglycemic agent; 7) known to be allergic to metformin hydrochloride and its analogues; 8) Patients who are participating in or have participated in other clinical trials in the past 3 months; 9) oral contraceptives or hormonal drugs during the trial; 10) Other patients identified by the investigator as unfit for the study; Refusal of follow-up request. Ovarian cancer exclusion criteria: 1) Those who have previously received chemotherapy and pelvic area radiotherapy; 2) Combine endocrine diseases (such as PCOS, hyperprolactinemia, hyperandremia, adrenal dysfunction, etc.) that affect ovarian function; 3) Combine cardiovascular, liver, kidney, infectious diseases, hematopoietic system and other serious diseases, with a history of lactic acidosis or high risk factors; 4) Pregnant or lactating women; 5) A history of diabetes is currently taking any hypoglycemic agent; 6) Known to be allergic to metformin hydrochloride and its analogues; 7) Patients who are participating in or have participated in other clinical trials for the past 3 months; 8) Oral contraceptives or hormonal drugs during the trial; 9) Other patients identified by the investigator as unfit for the study; Refusal of follow-up request. Exclusion criteria for gestational trophoblastic tumors: 1) Those who have previously received chemotherapy and pelvic area radiotherapy; 2) Combine endocrine diseases (such as PCOS, hyperprolactinemia, hyperandremia, adrenal dysfunction, etc.) that affect ovarian function; 3) Combine cardiovascular, liver, kidney, infectious diseases, hematopoietic system and other serious diseases, with a history of lactic acidosis or high risk factors; 4) Pregnant or lactating women; 5) A history of diabetes is currently taking any hypoglycemic agent; 6) known to be allergic to metformin hydrochloride and its analogues; 7) Patients who are participating in or have participated in other clinical trials for the past 3 months; 8) Oral contraceptives or hormonal drugs during the trial; 9) Other patients id
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ovarian function recovery (Menstruation or AMH); | — |
Secondary
| Measure | Time frame |
|---|---|
| Sex hormones+AMH+InhibinB;5-year pregnancy outcome;Safety assessment;Tumor prognosis; | — |
Countries
China
Contacts
Public ContactShixuan Wang
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed