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The present study is to determine the adverse effects and clinical efficacy of AI combined with Capecitabine metronomic chemotherapy in postmenopausal breast cancer patients with Estrogen receptor and/or Progestrogen receptor positive.
Capecitabine (Xeloda ®) is currently the most biologically active oral fluoropyrimidine drug, and is widely used as first-line and second-line rescue therapy for advanced breast cancer ,third-generation aromatase inhibitors (AI) is the preferred adjuvant endocrine therapy for Postmenopausal hormone-sensitive breast cancer. Study showed that AI combined with metronomic chemotherapy could improve the objective response and clinical benefit in neoadjuvant therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronomic Capecitabine and AI | Experimental | Postmenopausal Hormone receptor positive breast cancer patients who wanted to conserve breast were enrolled to receive capecitabine 500mg/tid p.o plus one of the aromatase inhibitors (AIs):Anastrozole 1mg/day p.o, and who had first line or second line Letrozole therapy failure were switched to capecitabine 500mg/tid p.o plus Exemestane 25mg/day p.oï¼›or Exemestane therapy failure were switched to capecitabine 500mg/tid p.o plus Letrozole 2.5mg/day p.o. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | metronomic use: capecitabine 500mg/tid |
|
| Measure | Description | Time Frame |
|---|---|---|
| adverse events | adverse events (Hand-foot syndrome,Gynecological events, blood lipids, thrombosis, cardiovascular diseases,and etc.) | average 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival (PFS) | average 10 months |
| TTF | time to treatment failure(TTF) | average 10 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guang-Yu Liu, MD | Contact | 86-021-64175590 | 8808 | liugy123@yahoo.com |
| Jian-wei Li, MD | Contact | 86-021-64175590 | 8808 | doctorljw@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Guang-yu Liu, MD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FUSCC | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30361875 | Derived | Li JW, Zuo WJ, Ivanova D, Jia XQ, Lei L, Liu GY. Metronomic capecitabine combined with aromatase inhibitors for new chemoendocrine treatment of advanced breast cancer: a phase II clinical trial. Breast Cancer Res Treat. 2019 Jan;173(2):407-415. doi: 10.1007/s10549-018-5024-3. Epub 2018 Oct 25. |
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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 |
|---|---|
| D000069287 | Capecitabine |
| D047072 | Aromatase Inhibitors |
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
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| aromatase Inhibitors (AIs) | Drug | Anastrozole 1mg/day p.o,Exemestane 25mg/day,Letrozole 2.5mg/day p.o. |
|
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |