Granisetron Transdermal Patch for Prophylaxis of Delayed CINV

• Granisetron transdermal patch (Drug), also known as sancuso: Granisetron transdermal delivery system (GTDS) is the first 5-HT3 drug to be transdermally delivered and represents a convenient alternative to oral and intravenous antiemetics for the treatment of chemotherapy-induced nausea and vomiting.
• Palonosetron (Drug): Palonosetron is a second-generation 5-HT3 receptor antagonist with proposed higher efficacy and sustained action for prophylaxis of postoperative nausea and vomiting (PONV).
• Aprepitant (Drug): Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors.
• Fosaprepitant (Drug): Fosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting.
• Dexamethasone (Drug): Dexamethasone, one of the glucocorticoids, has been suggested as a first-line drug for preventing low-level emetogenic chemotherapy- and radiotherapy-induced nausea and vomiting.

Primary outcomes

• complete response (CR) in delay phase of CINV [From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)]: To compare the complete response (CR) of Granisetron transdermal patch to Palonosetron (complete response is defined as no vomiting and no rescue medication) in delay phase of CINV

Secondary outcomes

• complete response (CR) in the acute and overall phase of CINV [From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)]: 1\. To compare the complete response (CR) of Granisetron transdermal patch to Palonosetron (complete response is defined as no vomiting and no rescue medication) in the acute and overall phase of CINV
• complete control (CC) in delay phase of CINV [From 24 hours after initiating administration of chemotherapy agents to day 7 (24-168 hours)]: 2\. To compare the complete control (CC) of Granisetron transdermal patch to Palonosetron (complete control is defined as no vomiting, mild nausea and no rescue medication) in delay phase of CINV
• complete control (CC) in the acute and overall phase of CINV [From initiating administration of chemotherapy agents to day 1 (0-24 hours) and day 7 (0-168 hours)]: 3\. To compare the complete control (CC) of Granisetron transdermal patch to Palonosetron (complete control is defined as no vomiting and no rescue medication) in the acute and overall phase of CINV
• Patients' satisfaction with antiemetic therapy (assessed using a 10-cm visual analog scale at the time of patch removal [7 days]: "dissatisfied" on the left end (0 cm) of visual analog scale and the "very satisfied" on the right end of visual analog scale (10 cm)

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

1. Female aged ≥ 18 years;
2. Pathologically confirmed breast cancer;
3. The physical status score ECOG ≤ 2;
4. Life expectancy of ≥3 months;
5. Patients first or had already received chemotherapy;
6. Patients scheduled to receive HEC/MEC chemotherapy, and the main emetic drugs will be used within a single day;
7. Patients first use of granisetron transdermal patch;
8. In accordance with the indication of chemotherapy and basic requirements;

   * Peripheral haematology: Hb ≥8.0g/dL; absolute neutrophil count≥1.5×109/L; platelet count ≥80×109/L
   * Blood biochemistry: Total bilirubin < 1.5×ULN, ALT and AST ≤ 2.5×ULN; if liver metastasis, ALT and AST < 5×ULN, creatinine ≤ 1.5×ULN
9. Patients voluntarily participate and sign the informed consent form;
10. Be able to read, understand and complete patient diaries independently.

Exclusion Criteria:

1. Contraindicated to 5-HT receptor antagonists, NK-1 receptor antagonist or dexamethasone;
2. Patients have used 5-HT receptor antagonist, NK1 receptor antagonist or any study drugs within 4 weeks before chemotherapy
3. Any nausea and vomiting (II or above) within 72 hours before the start of chemotherapy;
4. According to the judgment of the investigators, there are concomitant diseases (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.) that seriously endanger the safety of the patient or affect the completion of the study;
5. Patients scheduled to receive radiotherapy of whole body, brain or upper abdomen;
6. Confirmed by craniocerebral CT or MRI, patients with brain tumor lesions or patients taking drugs to treat brain tumors or epileptic symptoms;
7. History of drug abuse and alcohol dependence;
8. Pregnancy, lactation or intended pregnancy;
9. History of allergic reactions to drugs with similar chemical structures, or to transdermal therapeutic systems, including commercial dressings such as Elastoplast®
10. Unable to swallow, having intestinal obstruction, or other factors that affect the taking and absorption of the drug;
11. Long-term use of any inhibitors or inducers of CYP3A4, or take these drugs within 4 weeks before the first day of chemotherapy;
12. Other situations evaluated by investigators as unsuitable for enrollment.

• Results publication: Liu X, Meng Y, Du Y, Mu Y, Li G, Li H, Guan X, Zhang J. Granisetron transdermal delivery system versus palonosetron in the prevention of long-delayed nausea and vomiting: a phase III randomized trial. Oncologist. 2026 Feb 5;31(3):oyag007. doi: 10.1093/oncolo/oyag007. PMID 41520166