Randomized double-blind phase 3 study of granisetron vs palonosetron combined with dexamethasone plus fosaprepitant for patient with breast cancer treated with peri-operative AC/EC/FAC/FEC chemotherapy

Randomized double-blind phase 3 study of granisetron vs palonosetron combined with dexamethasone plus fosaprepitant for patient with breast cancer treated with peri-operative AC/EC/FAC/FEC chemotherapy - Palonosetron vs granisetron as 3 drug combination to control emesis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008897

Enrollment

330

Registered

2012-09-11

Start date

2012-11-21

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

Granisetron Palonosetron

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Invasive breast cancer confirmed by histological diagnosis. 2. Eligible for peri-operatinve AC/ EC/ FAC/FEC chemotherapy and planning for it. 3. Age over 20 years old 4. ECOG PS as 0, 1, or 2 5. Adequate organ function defined as belows; WBC >= 3000 mm^3 ANC >= 1500 mm^3 Hb >= 8 g/ dl Plt >= 10 x 10^4/mm^3 AST, ALT <= 100 IU/ L T-Bil <= 1.5 mg/ dl sCr <= 1.2 mg/ dl PaO2 >= 60 Torr or SpO2 >= 93 % (room air) 6. estimated survival more than 90 dayes 7. Written informed consent obtained

Exclusion criteria

Exclusion criteria: 1. Prior cancer chemotherapy 2. Prior radiation therapy during last 14 days 3. Receiving anti-emetic medication during last 72 hours 4. Vomitting at entry 5. Nausea Grade 2 or more (CTCAE ver. 4) at entry 6. Local or systemic infection requiring treatment 7. Severe comorbid condition such as GI bleeding, ileus, heart disease, glaucoma, diabetes 8. History of severe hypersensitivity 9. Severe psychological problem 10. Pregnant or lactating woman, or woman not going to contracept 11. HBsAg positive 12. Judged as ineligible by treating physiscian

Design outcomes

Primary

Measure	Time frame
Complete response rate for delayed emesis, defined as proportion of patients without vomiting nor rescue usage for emesis during 24 to 120 hours after chemotherapy	—

Secondary

Measure	Time frame
Complete response rate for emesis in acute (0 &#8211; 24 hours after chemotherapy) overall (0 to 120 hours after chemotherapy) phase, completer response rate for nausea or vomiting for acute/ delayed/ overall phase, safety	—

Countries

Japan

Contacts

Public ContactShinichiro Nakamura

West Japan Oncology Group WJOG datacenter

datacenter@wjog.jp06-6633-7400

Outcome results

None listed

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