One day antiemetic prophylaxis of NEPA (netupitant plus palonosetron) and dexamethasone to prevent chemotherapy-induced nausea and vomiting (CINV) in breast cancer patients receiving a combination chemotherapy of doxorubicin or epirubicin with cyclophosphamide (AC-based regimen)

Phase 1

• Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV) in breast cancer patients receiving a combination chemotherapy of doxorubicin or epirubicin with cyclophosphamide (AC-based regimen); MedDRA version: 20.0Level: LLTClassification code 10008443Term: Chemotherapy antiemetic prophylaxsisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: LLTClassification code 10008448Term: Chemotherapy induced emesis prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: LLTClassification code 10049091Term: Chemotherapy antiemetic prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: LLTClassification code 10008449Term: Chemotherapy inducted emesis prophylaxisSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 21.1Level: LLTClassification code 10036899Term: Prophylaxis against chemotherapy induced vomitingSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003316-20-IT
• Lead Sponsor: CONSORZIO ONCOTECH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-06
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

–Women >= 18 years old.
–Histologically or cytologically confirmed diagnosis of breast cancer.
–Na¿f patients.
–Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclofosfamide (AC-based regimen).
–ECOG Performance Status 0-2.
–Body Mass Index (BMI) >= 18.5.
–Written informed consent.
–If women of childbearing potential age: reliable contraceptive measures must be used.
–Normal hepatic function (<= 2 times the upper limit of normal for liver transaminases) and renal function (creatinine < 1.5 times the upper limit of normal).
–Ability and willingness of the patient to complete the diary.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 135
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

–Advanced/metastatic breast cancer.
–Patients already submitted to non-AC-based chemotherapy.
–Treatment with investigational medications within 30 days before NEPA.
–Myocardial infarction within the last 6 months.
–Documented or known hypersensitivity to 5HT3RA or NK1RA and excipients.
–Uncontrolled diabetes mellitus.
–Nausea and vomiting at baseline.
–Chronic use of other antiemetic agent(s).
–Patient’s inability to take oral medication.
–Gastrointestinal obstruction or active peptic ulcer.
–Pregnancy or breastfeeding
–Prior malignancies at other sites except surgically treated non-melanoma skin cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for >= 5 years.
–Psychiatric or CNS disorders interfering with ability to comply with study protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if the activity of one day of NEPA plus dexamethasone, to prevent chemotherapy-induced nausea and vomiting in breast cancer patients receiving adjuvant AC-based chemotherapy, is maintained during all the chemotherapy cycle treatment (maximum 4 cycles);Secondary Objective: NA;Primary end point(s): The rate of patients achieving and maintaining a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase;Timepoint(s) of evaluation of this end point: during the overall phase (From day 1 to day 5 after any AC-based chemotherapy administration) for a maximum 4 cycles.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): •rate of complete response (no vomiting and no use of rescue medication)<br>•rate of complete control (defined as complete response with a maximum grade of mild nausea)<br>•rate of emesis-free patients<br>•severity of nausea graded according to Likert<br>•patient global satisfaction with antiemetic therapy, as measured by a visual analog scale (VAS)<br>•Safety profile.;Timepoint(s) of evaluation of this end point: During the Acute Phase (0-24 hours after chemotherapy), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle and separately on single days of all chemotherapy cycles, up to 4 cycles