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This study is a prospective, controlled phase IV clinical trial among postmenopausal patients with hormone receptor-positive breast cancer.The main purpose is to compare the effects of steroidal aromatase inhibitor (AI) exemestane and non-steroidal AIs on the lipid levels of breast cancer patients.
The study subjects are composed of postmenopausal women with hormone receptor-positive breast cancer who have received exemestane, anastrozole or letrozole followed by testing of safety variables such as low-density lipoprotein- cholesterol (LDL-C), triglyceride(TC), total cholesterol, high-density lipoprotein cholesterol(HDL), blood calcium, transaminase and fasting plasma glucose at different time intervals in two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| steroidal aromatase inhibitors(AIs) | Exemestane 25mg Qd for 5 years |
| |
| non-steroidal aromatase inhibitors(AIs) | Letrozole 2.5mg Qd or Anastrozole 1mg Qd for 5 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exemestane | Drug |
| ||
| Letrozole |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of patients whose low density lipoprotein-cholesterol(LDL-C) level ≥ 4.14 mmol/L in 2 years of administration among groups | Change of LDL-C level from Baseline to up to 2 years |
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Inclusion Criteria:
Pathologic analysis verifies to be early-stage invasive breast cancer while immunohistochemistry shows estrogen receptor(ER) and/or progesterone receptor(PR) positive (ER/PR positive is defined that >1% of cells are positive).
The patients have received surgery for breast cancer and recovered well for an interval of at least 1 week.
The patients have received post-operational adjuvant chemotherapy and/or adjuvant radiotherapy whereas the interval of chemotherapy and/or adjuvant radiotherapy is more than 2 weeks.
The postmenopausal women have been confirmed to be to menopausal as defined in NCCN guidelines(including post bilateral oophorectomy; age≥60 year-old; age≤60 year-old, menopause for more than 1 year and plasma Follicle-Stimulating Hormone (FSH) and estradiol levels meet the menopausal scope).
Do not receive concomitant endocrine therapy, e.g. drug-induced menopause, tamoxifen.
The patients do not have severe cardiopulmonary dysfunction.
ECOG score: 0-1
The patients have enough organ function and meet the scope of aromatase inhibitors(AIs) therapy. The laboratory test indexes must comply with the following requirements:
Blood routine: neutrophil≥1.5G/L, platelet count ≥75G/L, hemoglobin ≥100g/L Liver function: serum bilirubin ≤ 2 times the upper limit of normal value; ALT and AST≤3 times the upper limit of normal value; Renal function: serumcreatinine≤140μmol/L
Serum low density lipoprotein-cholesterol(LDL-C) value <3.37mmol/L
Imaging examination identifies none of local recurrence or distal metastasis.
No other combined malignancy.
The patients have good compliance to the therapy and follow-up to be scheduled and are able to understand the study protocol and sign the Informed Consent Form.
Exclusion criteria
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postmenopausal women with hormone receptor-positive breast cancer who have received surgery
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| Name | Affiliation | Role |
|---|---|---|
| Peng Yuan | Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32518597 | Derived | Wang X, Zhu A, Wang J, Ma F, Liu J, Fan Y, Luo Y, Zhang P, Li Q, Xu B, Yuan P. Steroidal aromatase inhibitors have a more favorable effect on lipid profiles than nonsteroidal aromatase inhibitors in postmenopausal women with early breast cancer: a prospective cohort study. Ther Adv Med Oncol. 2020 May 26;12:1758835920925991. doi: 10.1177/1758835920925991. eCollection 2020. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
| Anastrozole | Drug |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |