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| Name | Class |
|---|---|
| Sun Yat-sen University | OTHER |
| First People's Hospital of Foshan | OTHER |
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To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).
There are several options for MBC patients who are responding to chemotherapy, to continue treatment with a fix number of cycles or until disease progression which also known as maintenance chemotherapy (MCT), to stop chemotherapy and take a watch and wait strategy, or to stop chemotherapy and start the maintenance endocrine therapy (MET) for hormone receptor (HR) positive patients. Since the role of maintenance therapy in prolonging the overall survival (OS) and progression-free survival (PFS) of MBC was controversial in previous studies, the investigators performed a systematic review of randomized controlled trials to detect the association of survival with maintenance therapy in patients with MBC after first-line chemotherapy. And the investigators further performed a multi-center retrospective real-world study to evaluate these two maintenance modalities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MCT Group | People who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy. |
| |
| MET Group | People who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy. |
| |
| Observation Group | People who didn't receive any maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | 1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | From enrollment to death (for any reason) | Estimated 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | From enrollment to progression or death (for any reason) | Estimated 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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This is a multi-center real world study to compare maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and observation in patients with HR-positive MBC who achieved disease control after first-line chemotherapy. Patients were retrospectively enrolled from 3 different medical center.
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| Name | Affiliation | Role |
|---|---|---|
| Herui Yao, PhD | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First People's Hospital of Foshan | Foshan | Guangdong | China | |||
| Sun Yat-sen Memorial Hospital,Sun Yat-sen University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35130417 | Derived | Ren W, Yu Y, Hong H, Wang Y, Gao Q, Chen Y, Chen P, Zhao J, Ou Q, Lin D, Fu T, Tan Y, Li C, Xie X, Ye G, Tang J, Yao H. Clinical Evidence of Chemotherapy or Endocrine Therapy Maintenance in Patients with Metastatic Breast Cancer: Meta-Analysis of Randomized Clinical Trials and Propensity Score Matching of Multicenter Cohort Study. Cancer Res Treat. 2022 Oct;54(4):1038-1052. doi: 10.4143/crt.2021.698. Epub 2022 Feb 4. |
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| Liposomal doxorubicin | Drug | 50 mg/m 2 IV day 1, cycled every 28 days |
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| Gemcitabine | Drug | 800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days |
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| Fulvestrant | Drug | 500mg IH Days 0, 14, 28, then every 28 days |
|
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| Anastrozole | Drug | 1mg PO qd |
|
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| Letrozole | Drug | 2.5mg PO qd |
|
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| Guangzhou |
| Guangdong |
| 510000 |
| China |
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510000 | China |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| D060046 | Maintenance Chemotherapy |
| C506643 | liposomal doxorubicin |
| D000093542 | Gemcitabine |
| D000077267 | Fulvestrant |
| D000077384 | Anastrozole |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D004958 | Estradiol |
| D004963 | Estrenes |
| D004962 | Estranes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045166 | Estradiol Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
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