An Observational, Multicenter Study Evaluating the Safety of ReAl-lifePertuzumab and Trastuzumab Fixed Dose Combination: the RAPID Study (GIM30-RAPID)

This is a single arm prospective, observational multi-centre study in patients with HER-2 positive breast cancer who have completed concurrent chemotherapy with pertuzumab and trastuzumab administered IV and are currently receiving or will be receiving maintenance therapy with PH FDC SC and have at least 6 cycles of therapy expected with PH FDC SC to conclude pre-established oncological treatment.

Treatment of the patients will not be determined or assigned by study procedures but will be based on normal clinical practice. Only data available per clinical practice will be collected within this study. The treatment decision must have been taken prior to and irrespective of patient's inclusion in the study.

Study Overview

• Status: Completed
• Conditions: Breast Cancer

Detailed Description

Primary objective

• The primary objective of the study is to evaluate the safety of pertuzumab and trastuzumab (PH) fixed-dose combination (FDC) for subcutaneous (SC) administration in patients with HER-2 positive breast cancer who have completed concurrent chemotherapy with pertuzumab and trastuzumab administered intravenously (IV) and are currently receiving or will be receiving maintenance therapy with PH FDC SC.

Secondary objectives

The secondary exploratory objectives of the study are:

• To assess the patient's social cost saving by means of a specific questionnaire;
• To assess the patient's health related quality of life (HRQOL).

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80131
    • Istituto Nazionale Tumori "Fondazione G. Pascale"
  • Pollena Trocchia, Italy, 80040
    • ASL Napoli 3 sud - Stabilimento di Pollena " Cav. R. Apicella"
  • Rome, Italy, 00144
    • IRCCS Istituto Nazionale Tumori Regina Elena
  • Rome, Italy
    • Fondazione Policlinico Universitario A. Gemelli IRCSS
  • AV
    • Avellino, AV, Italy, 83100
      • A.O.R.N. San Giuseppe Moscati
  • CE
    • Caserta, CE, Italy, 81100
      • A.O.R.N. Caserta "Sant'Anna e San Sebastiano"
  • PN
    • Aviano, PN, Italy, 33081
      • Irccs - Centro Riferimento Oncologico (C.R.O.) Di Aviano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with HER-2 positive breast cancer who have completed concurrent chemotherapy with pertuzumab and trastuzumab administered IV and are currently receiving or will be receiving maintenance therapy with PH FDC SC and have at least 6 cycles of therapy expected with PH FDC SC to conclude pre-established oncological treatment.

Description

Inclusion Criteria:

• Written informed consent of the patient;
• Female and male patients aged ≥ 18 years (no upper limit);
• Patients with HER-2 positive breast cancer, who have completed concurrent chemotherapy with pertuzumab and trastuzumab IV and are currently receiving or will be receiving maintenance therapy with PH FDC SC according to locally approved indication;
• Patients with expected at least 6 cycles of therapy with PH FDC SC to conclude pre-established oncological treatment;

Exclusion Criteria:

• Life expectancy < 6 months;
• Presence of any contraindication with regard to treatment with PH FDC SC as specified in the corresponding Summary of Product Characteristics (SmPCs) approved in Italy;
• Concomitant participation in another interventional or non-interventional trial.
• Patients with less than 6 remaining cycles of therapy with PH FDC SC to conclude pre-established oncological treatment

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
patients with HER-2 positive breast cancer; patients with HER-2 positive breast cancer who have completed concurrent chemotherapy with pertuzumab and trastuzumab administered IV and are currently receiving or will be receiving maintenance therapy with PH FDC SC and have at least 6 cycles of therapy expected with PH FDC SC to conclude pre-established oncological treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number and percentage of patients with grade 3-4 adverse events (AEs), according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).	From enrollment to the end of the study (about 24 months)

Secondary Outcome Measures

Outcome Measure	Time Frame
Other safety endpoints: number and percentage of patients with any AE, serious AEs, fatal AEs, AEs leading to withdrawal of study drug, adverse events of special interest (AESI, refer to Section 13.1.3 for the list);	From enrollment to the end of the study (about 24 months)
Patient's social cost evaluated by means of estimation of indirect costs (Loss of productivity for patients and caregiver) using a specific questionnaire administered at the Screening, after the third cycle of therapy and at the End of Treatment visit;	From enrollment to the end of the study (about 24 months)
Patient's HRQOL, evaluated by means of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) administered at the Screening, after the third cycle of therapy and at the End of Treatment visit.	From enrollment to the end of the study (about 24 months)

Collaborators and Investigators

• Sponsor: Fondazione Oncotech

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): November 29, 2024

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: GIM30-RAPID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: It is not yet known if there will be a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No