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

NCT ID: NCT03862144

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-12
• Study Completion Date: 2017-04-03

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Netupitant/Palonosetron & Dexamethasone

• 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.

Group Type: EXPERIMENTAL

Netupitant/Palonosetron

Intervention Type: DRUG

Interventions

Netupitant/Palonosetron

Intervention Type: DRUG

Other Intervention Names

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

Eligibility Criteria

Inclusion Criteria

1. Women ≥ 18 years old

2. Histologically or cytologically confirmed diagnosis of breast cancer

3. Naïve patients

4. Be scheduled to receive adjuvant chemotherapy with anthracycline (doxorubicin or epirubicin) + cyclophosphamide (AC-based regimen)

5. ECOG (Eastern Cooperative Oncology Group) performance status 0-2

6. Body Mass index (BMI) ≥ 18.5

7. Written informed consent

8. 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

9. 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);

10. Ability and willingness of the patient to complete the diary.

Exclusion Criteria

1. Advanced/metastatic breast cancer

2. Patients already submitted to non-AC-based chemotherapy

3. Treatment with investigational medications in 30 days before NEPA

4. Myocardial infarction within the last 6 months

5. Documented or known hypersensitivity to 5HT3RA (5-Hydroxytryptamine Receptor 3 Antagonists) or NK1RA (Neurokinin-1 Receptor Antagonists) and excipients

6. Uncontrolled diabetes mellitus

7. Nausea and vomiting at baseline

8. Chronic use of other antiemetic agent(s)

9. Patient's inability to take oral medication

10. Gastrointestinal obstruction or active peptic ulcer

11. Pregnancy or breastfeeding

12. 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

13. Psychiatric or CNS (Central Nervous System) disorders interfering with ability to comply with study protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Consorzio Oncotech

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michelino De Laurentiis, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute "Fondazione Pascale", Naples

References

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.

Reference Type: DERIVED

PMID: 32188417 (View on PubMed)

Other Identifiers

GIM15-NEPA

Identifier Type: -

Identifier Source: org_study_id