Metastatic Breast CancerEVANCT06106711
The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).
An observational study of Metastatic Breast Cancer, run by Centro di Riferimento Oncologico - Aviano at 3 sites in Italy.
Trial summary
The study stems from the need to detect adverse events arising after the administration of Antibody-Drug Conjugates (ADCs) used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 92 participants
- Where
- 3 sitesItaly
- Study dates
- 2 Nov 2023to 30 Sep 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 92 patients diagnosed with stage IV breast cancer treated at the Department of Medical Oncology and Cancer Prevention, IRCCS National Cancer Institute of Aviano and at the other involved clinical centers considered eligible for the study will be enrolled, after providing written informed consent.
Who may be able to join
- Female gender;
- Age ≥ 18 years;
- Signature of consent to participate in the study and to the processing of personal data (Privacy);
- Diagnosis of stage IV breast cancer;
- Systemic treatment with T-DM1, T-DXD or SG as monotherapy;
- Absence of cognitive decline, expressed by a score greater than or equal to 4 on the Six Item Screener questionnaire;
- Good understanding of the Italian language;
- Willingness and ability to adhere to scheduled visits, treatment plan, laboratory tests and study procedures.
Who cannot join
- All patients who do not meet the above criteria will be excluded from the study.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Centro di Riferimento Oncologico (CRO)
Aviano, Pordenone, 33081
Cristina Mazzega Fabbro, cristina.mazzega@cro.it
Fondazione IRCCS Istituto Nazionale dei tumori
Milan, 20133
Giulia Antonacci, giulia.antonacci@istitutotumori.mi.it
Giulia Antonacci
Istituto Nazionale Tumori IRCCS G. Pascale
Naples, 80131
Maria Rosaria Esposito, mariarosaria.esposito@istitutotumori.na.it
Maria Rosaria Esposito
About this study
The study stems from the need to detect adverse events arising after the administration of Antibody-Drug Conjugates (ADCs) used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.
Read the detailed description
The study stems from the need to detect adverse events arising after the administration of ADCs used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.Through the findings of toxicities related to the ADCs, it will be possible to highlight which are the issues that most affect patients undergoing these cancer treatments. The analysis of the data collected will also make it possible to highlight any toxicities not yet considered or/and of new onset. In addition useful elements may emerge from responses to the quality of life questionnaire, to cope with the difficulties expressed by patients regarding daily life activities, social relations, work and family. Such contributions will be fundamental to the construction of integrated care pathways, the aim of which is to involve a specialized nurse as part of a multidisciplinary team.
- Conditions
- Metastatic Breast Cancer
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs) arising during treatment and degree of toxicity
Frequency adverse events (AEs) arising during treatment with TDM-1, T-DXd and SG
Measured: up to 1 year
Adverse events (AEs) arising during treatment and degree of toxicity
description of degree of toxicity of AEs classified using the international classification system CTCAE (version 5.0)
Measured: up to 1 year
Quality of life of patients during treatment
To assess the quality of life of patients treated with TDM-1, T-DXd, and SG through the administration of the EORTC QLQ-C30 questionnaire. Results will be reported as median and quartiles
Measured: up to 1 year
Secondary outcomes (6)
Dose-reduction
to identify the percentage of patients who require a reduction in dosage due to suboptimal treatment tolerance
Measured: up to 1 year
Treatment discontinuation
Identify the percentage of patients who discontinues cancer therapy due to suboptimal treatment tolerance
Measured: up to 1 year
AEs - level of distress
difference in distress levels measured with Distress thermometer between patients with different AEs secondary to cancer treatments
Measured: up to 1 year
To describe the actions taken to manage treatment-related AEs
Description of the actions taken to manage treatment-related AEs
Measured: up to 1 year
Analyze the level of concordance between the AEs detected by health care personnel and the patient's subjective assessment
Concordance between the AEs detected by health care personnel and the patient's subjective assessment
Measured: up to 1 year
Sources of distress
Frequency for answers to Distress thermometer problem list
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start2 Nov 2023 (estimated)
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic 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
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro di Riferimento Oncologico - Aviano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Cristina Mazzega Fabbro, MSc, Principal investigator, Centro di Riferimento Oncologico (CRO), IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06106711
- Sponsor's protocol ID
- CRO-2023-22
- Acronym
- EVA
- Status last verified
- Sep 2023
- First submitted
- 24 Oct 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Adverse Events, Produced by Antibodies Conjugates, on Quality of Life in Patients With Metastatic Breast Cancer: Multicentric, Observational Study (EVA).
- ClinicalTrials.gov ID
- NCT06106711
- Acronym / sponsor ID
- EVA / CRO-2023-22
- Conditions
- Metastatic Breast Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Centro di Riferimento Oncologico - AvianoUniversity, hospital or other
- Study start
- 2 Nov 2023 (estimated)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 30 Oct 2023 (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.
The study stems from the need to detect adverse events arising after the administration of Antibody-Drug Conjugates (ADCs) used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.
Detailed description
The study stems from the need to detect adverse events arising after the administration of ADCs used in the treatment of metastatic breast cancer in a real life context and to correlate the same with the quality of life reported by patients.Through the findings of toxicities related to the ADCs, it will be possible to highlight which are the issues that most affect patients undergoing these cancer treatments. The analysis of the data collected will also make it possible to highlight any toxicities not yet considered or/and of new onset. In addition useful elements may emerge from responses to the quality of life questionnaire, to cope with the difficulties expressed by patients regarding daily life activities, social relations, work and family. Such contributions will be fundamental to the construction of integrated care pathways, the aim of which is to involve a specialized nurse as part of a multidisciplinary team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 92 patients diagnosed with stage IV breast cancer treated at the Department of Medical Oncology and Cancer Prevention, IRCCS National Cancer Institute of Aviano and at the other involved clinical centers considered eligible for the study will be enrolled, after providing written informed consent.
Key inclusion criteria (8 listed)
- Female gender;
- Age ≥ 18 years;
- Signature of consent to participate in the study and to the processing of personal data (Privacy);
- Diagnosis of stage IV breast cancer;
- Systemic treatment with T-DM1, T-DXD or SG as monotherapy;
Key exclusion criteria (1 listed)
- All patients who do not meet the above criteria will be excluded from the study.
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
Adverse events (AEs) arising during treatment and degree of toxicity
Time frame: up to 1 year
Frequency adverse events (AEs) arising during treatment with TDM-1, T-DXd and SG
Adverse events (AEs) arising during treatment and degree of toxicity
Time frame: up to 1 year
description of degree of toxicity of AEs classified using the international classification system CTCAE (version 5.0)
Quality of life of patients during treatment
Time frame: up to 1 year
To assess the quality of life of patients treated with TDM-1, T-DXd, and SG through the administration of the EORTC QLQ-C30 questionnaire. Results will be reported as median and quartiles
6 secondary outcomes
Dose-reduction
Time frame: up to 1 year
Treatment discontinuation
Time frame: up to 1 year
AEs - level of distress
Time frame: up to 1 year
To describe the actions taken to manage treatment-related AEs
Time frame: up to 1 year
Analyze the level of concordance between the AEs detected by health care personnel and the patient's subjective assessment
Time frame: up to 1 year
Sources of distress
Time frame: up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
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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.
Cristina Mazzega Fabbro, MSc principal investigator
Centro di Riferimento Oncologico (CRO), IRCCS
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Centro di Riferimento Oncologico - Aviano at 3 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 8 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cristina Mazzega Fabbro, MSc (0434659111, cristina.mazzega@cro.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) arising during treatment and degree of toxicity (time frame: up to 1 year). The study lists 3 primary outcomes in all. 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 30 Oct 2023.