To evaluate the efficacy and safety of NEPA combined with Megestrol Acetate versus NEPA combined with Dexamethasone in preventing nausea and vomiting caused by T-Dxd in breast cancer patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600116296

Enrollment

Unknown

Registered

2026-01-08

Start date

2026-01-30

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer patients receiving T-Dxd treatment

Interventions

Control group:NEPA + Dexamethasone

Experimental Group:NEPA + Megestrol Acetate

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged >=18 years; 2. Patients histologically or cytologically confirmed to have breast cancer; 3. Patients receiving the first/adequate dose of trastuzumab deruxtecan (T-Dxd) monoclonal antibody therapy; 4. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of <=2; 5. Subjects voluntarily and strictly comply with the study protocol requirements and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients taking medications that affect the assessment of nausea or vomiting (other 5-HT3 receptor antagonists, NK1 receptor antagonists, psychotropic drugs, or opiate analgesics); 2. Patients whose nausea or vomiting is highly likely to be caused by antitumor treatment methods other than ADC-containing drug therapy, as judged by the investigator; 3. Patients unsuitable for the use of glucocorticoids or progesterone; 4. Subjects with an allergic reaction to netupitant-palonosetron capsules or any of its excipients; 5. Factors significantly affecting the absorption of oral drugs, such as inability to swallow, chronic diarrhea, and intestinal obstruction; 6. Patients with severe mental diseases, or difficulty understanding questionnaires or communicating in Chinese; 7. Other conditions that may affect the conduct of the clinical study and the determination of study results, as judged by the investigator.

Design outcomes

Primary

Measure	Time frame
CR rate ;	—

Secondary

Measure	Time frame
CC rate ;Time of first occurrence of significant nausea and vomiting, as well as duration;Quality of life assessment;Incidence of ADC dose reduction due to adverse reactions;CR rate ;Proportion of patients undergoing salvage therapy;	—

Countries

China

Contacts

Public ContactChunfang Hao

Tianjin Medical University Cancer Institute and Hospital

haochf@163.com+86 22 23340123

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026