Clinical trial NCT06835348: An Observational, Multicenter Study Evaluating the Safety of ReAl-lifePertuzumab and Trastuzumab Fixed Dose Combination: the RAPID Study
Official title: An Observational, Multicenter Study Evaluating the Safety of ReAl-lifePertuzumab and Trastuzumab Fixed Dose Combination: the RAPID Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fondazione Oncotech
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: From enrollment to the end of the study (about 24 months)
Secondary outcomes:
measure: 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);
timeFrame: From enrollment to the end of the study (about 24 months)
measure: 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;
timeFrame: From enrollment to the end of the study (about 24 months)
measure: 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.
timeFrame: From enrollment to the end of the study (about 24 months)
Other outcomes:
Locations:
city: Avellino
country: Italy
facility: A.O.R.N. San Giuseppe Moscati
state: AV
city: Caserta
country: Italy
facility: A.O.R.N. Caserta "Sant'Anna e San Sebastiano"
state: CE
city: Aviano
country: Italy
facility: Irccs - Centro Riferimento Oncologico (C.R.O.) Di Aviano
state: PN
city: Naples
country: Italy
facility: Istituto Nazionale Tumori "Fondazione G. Pascale"
city: Pollena Trocchia
country: Italy
facility: ASL Napoli 3 sud - Stabilimento di Pollena " Cav. R. Apicella"
city: Rome
country: Italy
facility: IRCCS Istituto Nazionale Tumori Regina Elena
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCSS
Study officials:
References: