Breast CancerGIM30-RAPIDNCT06835348
An Observational, Multicenter Study Evaluating the Safety of ReAl-lifePertuzumab and Trastuzumab Fixed Dose Combination: the RAPID Study
An observational study of Breast Cancer, run by Fondazione Oncotech at 7 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 7 sitesItaly
- Study dates
- 3 Oct 2023to 29 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Italy7 sites
A.O.R.N. San Giuseppe Moscati
Avellino, AV, 83100
Irccs - Centro Riferimento Oncologico (C.R.O.) Di Aviano
Aviano, PN, 33081
A.O.R.N. Caserta "Sant'Anna e San Sebastiano"
Caserta, CE, 81100
Istituto Nazionale Tumori "Fondazione G. Pascale"
Naples, Naples, 80131
ASL Napoli 3 sud - Stabilimento di Pollena " Cav. R. Apicella"
Pollena Trocchia, 80040
IRCCS Istituto Nazionale Tumori Regina Elena
Rome, Rome, 00144
Fondazione Policlinico Universitario A. Gemelli IRCSS
Rome, Rome
About this study
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.
Read the 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).
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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);
Measured: 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;
Measured: 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.
Measured: From enrollment to the end of the study (about 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start3 Oct 2023
- Primary completion29 Nov 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Oncotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835348
- Sponsor's protocol ID
- GIM30-RAPID
- Acronym
- GIM30-RAPID
- Status last verified
- Feb 2025
- First submitted
- 14 Feb 2025
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Multicenter Study Evaluating the Safety of ReAl-lifePertuzumab and Trastuzumab Fixed Dose Combination: the RAPID Study
- ClinicalTrials.gov ID
- NCT06835348
- Acronym / sponsor ID
- GIM30-RAPID / GIM30-RAPID
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Fondazione OncotechUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Time frame: From enrollment to the end of the study (about 24 months)
3 secondary outcomes
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);
Time frame: 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;
Time frame: 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.
Time frame: From enrollment to the end of the study (about 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Fondazione Oncotech at 7 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: From enrollment to the end of the study (about 24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2025.