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| Name | Class |
|---|---|
| Shaanxi Provincial Cancer Hospital | OTHER |
| The First Affiliated Hospital of Henan University of Science and Technology | OTHER |
| Shanxi Bethune Hospital | OTHER |
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This study was a multicenter, prospective, controlled trial involving 120 breast cancer patients receiving T-DXd-based therapy. Participants were randomly assigned to either the experimental group (NEPA plus megestrol acetate) or the control group (NEPA plus dexamethasone), with 60 patients in each group. The intervention was administered over two treatment cycles. During this period, the onset time, frequency, and severity of nausea and vomiting were recorded and subjected to statistical analysis.
The primary objective of this study was to evaluate the efficacy and safety of netupitant/palonosetron capsules (NEPA) combined with megestrol acetate compared to the standard triple antiemetic regimen (NEPA plus dexamethasone) in preventing chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients undergoing T-DXd-containing regimens. The findings aim to generate clinical evidence to support optimal antiemetic management, minimize the risk of dose reduction or treatment discontinuation due to gastrointestinal adverse events, and ultimately improve patient quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEPA+ Megestrol Acetate | Experimental |
| |
| NEPA+ Dexamethasone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEPA | Drug | On the first day, oral administration of NEPA(netopitan 300mg+ palonosetron 0.50mg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The CR rate within 0-120 hours (0-5 days) after the first cycle of T-Dxd treatment | 0-120 hours (0-5 days) |
| Measure | Description | Time Frame |
|---|---|---|
| The CR rates of 0-24 hours, 24-120 hours, 120-240 hours and 0-504 hours after the first and second cycles of T-Dxd treatment. | 0-24 hours, 24-120 hours, 120-240 hours and 0-504 hours | |
| The CR rate within 0-120 hours (0-5 days) after the first cycle of T-Dxd treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| D019290 | Megestrol Acetate |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Tianjin Cancer Hospital Airport Hospital |
| UNKNOWN |
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| Dexamethasone | Drug | On the first day, oral administration of dexamethasone 6mg; From the 2nd to the 4th day, take dexamethasone 3.75mg orally per day. |
|
| Megestrol Acetate | Drug | From the 1st to the 10th day, take 160mg of Megestrol Acetate orally per day. |
|
| 0-120 hours (0-5 days) |
| The CC rates of 0-24 hours, 24-120 hours, 0-120 hours, 120-240 hours and 0-504 hours after the first and second cycles of T-Dxd treatment. | 0-24 hours, 24-120 hours, 0-120 hours, 120-240 hours and 0-504 hours |
| The time and duration of the first significant nausea and vomiting. | From the administration of T-Dxd to 21 days |
| The proportion of patients undergoing salvage treatment. | From the administration of T-Dxd to 21 days |
| The incidence of ADC reduction due to adverse reactions | From the administration of T-Dxd to 21 days |
| Evaluation of the EORTC QLQ-C30 (version 3) Quality of Life Questionnaire. | From the administration of T-Dxd to 21 days |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D008535 | Megestrol |