Randomized Phase II trial of palonosetron, aprepitant plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by chemotherapy for breast cancer

Randomized Phase II trial of palonosetron, aprepitant plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by chemotherapy for breast cancer - Randomized Phase II trial of palonosetron, aprepitant plus dexamethasone for 1 day with or without dexamethasone on days 2 and 3 in the prevention of nausea and vomiting induced by chemotherapy for breast cancer(KBCSG02)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000006977

Enrollment

Registered

2011-12-28

Start date

2011-03-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

breast cancer

Interventions

Palonosetron: day1 (0.75mg) Aprepitant: day1 (125mg), 2 (80mg), 3(80mg) Dexamethasone: day1(9.9mg), 2(6.6mg), 3(6.6mg) Palonosetron: day1 (0.75mg) Aprepitant: day1 (125mg), 2 (80mg), 3(80mg) Dex

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Histologically or cytologically proven breast cancer. 2) Aged 20 years or older. 3)No prior chemothearpy or radiotherapy for Breast Cancer. 4)Patients who are scheduled to receive high emetogenic chemotherapy for breast cancer. 5)Adequate organ function. 6)ECOG performance status of 0 or 1. 7)Written informed consent.

Exclusion criteria

Exclusion criteria: 1)Patients who has a convulsive disorders that need anticonvulsants therapy. 2)With nausea (CTCAE Grade2). 3)A history of sever allergic reaction with palonosetron or aprepitant or dexamethasone. 4)Pregnancy or the desire to preserve fecundity. 5)Receiving an antiemetic drug. 6)Receiving pimozide. 7)With mental disease or psychotic manifestation. 8)Any patients judged by the investigator to be unfit to participate in the study.

Design outcomes

Primary

Measure	Time frame
Complete Response Rate in overall phase(0-120 hours after chemotherapy)	—

Secondary

Measure	Time frame
-Complete Response Rate in acute and delayed phase -Complete Control Rate in overall, acute and delayed phase -The proportion of patients without nausea in overall, acute and delayed phase -Safety	—

Countries

Japan

Contacts

Public ContactYoshimasa Kosaka

Kitasato University School of Medicine Department of Surgery

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026