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NEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer (GIM15-NEPA)

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status

Completed

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Netupitant/Palonosetron

About this trial

This is an interventional prevention trial for Chemotherapy-induced Nausea and Vomiting focused on measuring nausea, vomiting, breast cancer, AC-based chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Women ≥ 18 years old
Histologically or cytologically confirmed diagnosis of breast cancer
Naïve patients
Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen)
ECOG (Eastern Cooperative Oncology Group) 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 during the study treatment period and up to 30 days after last NEPA administration
Acceptable 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.

Exclusion Criteria:

Advanced/metastatic breast cancer
Patients already submitted to non-AC-based chemotherapy
Treatment with investigational medications in 30 days before NEPA
Myocardial infarction within the last 6 months
Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) 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 (Central Nervous System) disorders interfering with ability to comply with study protocol

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Netupitant/Palonosetron & Dexamethasone

Arm Description

Netupitant/Palonosetron (NEPA) will be administered orally at the dose of 300 MG (milligrams) netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle. Dexamethasone 12 mg will be added on day 1 only of each cycle.

Outcomes

Primary Outcome Measures

Complete response

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 of all AC-based chemotherapy cycles

Secondary Outcome Measures

Acute and Delayed Phase Complete Response

Rate of complete control (defined as no emetic episode and no need for rescue medication)

Complete Control

Rate of complete control (defined as complete response with a maximum grade of mild nausea)

Emesis-Free

Percentage of emesis-free patients (no emetic episodes) after any AC-based chemotherapy administration.

Nausea

Presence of nausea graded according to Likert scale (none, mild, moderate and severe)

Global satisfaction with antiemetic therapy: Visual Analogue Scale (VAS)

Patient global satisfaction with antiemetic therapy, as measured by a Visual Analogue Scale (VAS). Scale ranges are 0-10 (0 represents maximum dissatisfaction, 10 represents maximum satisfaction)

Safety profile (according to CTCAE)

Safety profile according to CTCAE

Full Information

NCT ID

NCT03862144

First Posted

January 14, 2019

Last Updated

March 1, 2019

Sponsor

Consorzio Oncotech

1. Study Identification

Unique Protocol Identification Number

NCT03862144

Brief Title

NEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer

Acronym

GIM15-NEPA

Official Title

One Day Antiemetic Prophylaxis of NEPA (Netupitant Plus Palonosetron) and Dexamethasone to Prevent Chemotherapy-induced Nausea and Vomiting (CINV) in Breast Cancer Patients Receiving an AC-based Chemotherapy Regimen

Study Type

Interventional

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

May 12, 2016 (Actual)

Primary Completion Date

April 3, 2017 (Actual)

Study Completion Date

April 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Consorzio Oncotech

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study evaluates 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).

Detailed Description

Patients included in the study should be treated with the following antiemetic prophylaxis, during all the AC-based chemotherapy cycles, up to a maximum of 4 cycles: NEPA will be administered orally at the dose of 300 mg netupitant/0.5 palonosetron 1 hour before the start of any chemotherapy cycle. Dexamethasone 12 mg will be added on day 1 only of each cycle.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chemotherapy-induced Nausea and Vomiting

Keywords

nausea, vomiting, breast cancer, AC-based chemotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Phase II study, one stage Fleming design, open-label, multicenter, not comparative

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Netupitant/Palonosetron & Dexamethasone

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Netupitant/Palonosetron

Other Intervention Name(s)

Netupitant/Palonosetron 300 MG-0.5 MG Oral Capsule [AKYNZEO]

Primary Outcome Measure Information:

Title

Complete response

Description

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 of all AC-based chemotherapy cycles

Time Frame

During the overall phase (From day 1 to day 5 after any AC-based chemotherapy administration) for a maximum 4 cycles (each cycle is 21 days)

Secondary Outcome Measure Information:

Title

Acute and Delayed Phase Complete Response

Description

Rate of complete control (defined as no emetic episode and no need for rescue medication)

Time Frame

During the Acute Phase [0-24 hours after chemotherapy (CT)] and the Delayed (25-120 hours) phase

Title

Complete Control

Description

Rate of complete control (defined as complete response with a maximum grade of mild nausea)

Time Frame

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 (each cycle is 21 days), up to 4 cycles

Title

Emesis-Free

Description

Percentage of emesis-free patients (no emetic episodes) after any AC-based chemotherapy administration.

Time Frame

During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days)and separately on single days of all CT cycles,up to 4 cycles.Also during the period between two consecutive cycles

Title

Nausea

Description

Presence of nausea graded according to Likert scale (none, mild, moderate and severe)

Time Frame

During the Acute (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (of 21 days)and separately on single days of all chemotherapy cycles, up to 4 cycles.Also during the period between two consecutive cycles

Title

Global satisfaction with antiemetic therapy: Visual Analogue Scale (VAS)

Description

Patient global satisfaction with antiemetic therapy, as measured by a Visual Analogue Scale (VAS). Scale ranges are 0-10 (0 represents maximum dissatisfaction, 10 represents maximum satisfaction)

Time Frame

During the Acute Phase (0-24 hours after CT), the Delayed (25-120 hours), the Overall (0-120 hours) phases for each cycle (each cycle is 21 days) and separately on single days of all CT cycles, up to 4 cycles

Title

Safety profile (according to CTCAE)

Description

Safety profile according to CTCAE

Time Frame

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Women ≥ 18 years old Histologically or cytologically confirmed diagnosis of breast cancer Naïve patients Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen) ECOG (Eastern Cooperative Oncology Group) 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 during the study treatment period and up to 30 days after last NEPA administration Acceptable 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. Exclusion Criteria: Advanced/metastatic breast cancer Patients already submitted to non-AC-based chemotherapy Treatment with investigational medications in 30 days before NEPA Myocardial infarction within the last 6 months Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) 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 (Central Nervous System) disorders interfering with ability to comply with study protocol

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michelino De Laurentiis, MD, PhD

Organizational Affiliation

National Cancer Institute "Fondazione Pascale", Naples

Official's Role

Principal Investigator

12. IPD Sharing Statement

Citations:

PubMed Identifier

32188417

Citation

Caputo R, Cazzaniga ME, Sbrana A, Torrisi R, Paris I, Giordano M, Montesarchio V, Guarneri V, Amaducci L, Bilancia D, Cilenti G, Fabi A, Collova E, Schirone A, Bonizzoni E, Celio L, De Placido S, De Laurentiis M. Netupitant/palonosetron (NEPA) and dexamethasone for prevention of emesis in breast cancer patients receiving adjuvant anthracycline plus cyclophosphamide: a multi-cycle, phase II study. BMC Cancer. 2020 Mar 19;20(1):232. doi: 10.1186/s12885-020-6707-9.

Results Reference

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NEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer

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