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

NCT06835348 | Completed

• 1 other identifier: GIM30-RAPID
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Oncotech: lead

Study Sites (7)

A.O.R.N. San Giuseppe Moscati

Avellino, AV, 83100, Italy

Location

A.O.R.N. Caserta "Sant'Anna e San Sebastiano"

Caserta, CE, 81100, Italy

Location

Istituto Nazionale Tumori "Fondazione G. Pascale"

Naples, Naples, 80131, Italy

Location

Irccs - Centro Riferimento Oncologico (C.R.O.) Di Aviano

Aviano, PN, 33081, Italy

Location

IRCCS Istituto Nazionale Tumori Regina Elena

Rome, Rome, 00144, Italy

Location

Fondazione Policlinico Universitario A. Gemelli IRCSS

Rome, Rome, Italy

Location

ASL Napoli 3 sud - Stabilimento di Pollena " Cav. R. Apicella"

Pollena Trocchia, 80040, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: October 3, 2023
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

IT (7)