Long-term Safety and Efficacy of GBG Study Participants

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT05739591

Studienbeginn:
Oktober 2022

Letztes Update:
22.02.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
German Breast Group

Collaborator:
-

Studienleiter

Sibylle Loibl, Prof. Dr.
Study Chair
German Breast Group

Kontakt

Thomas Ballhausen, Dr.
Kontakt:
Phone: +49 6102 7480
E-Mail: eternity@gbg.de» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

MUI - Univ. Klinik f. Frauenheilkunde Innsbruck
6020 Innsbruck
AustriaRekrutierend» Google-Maps

Ordensklinikum Linz GmbH - BHS
4020 Linz
AustriaRekrutierend» Google-Maps

LKH Salzburg - PMU
5020 Salzburg
AustriaRekrutierend» Google-Maps

Studien-Informationen

Detailed Description:

This is a prospective and retrospective, international, multicenter, non-interventional,

observational study for collection of long-term safety and efficacy parameters of former GBG

study participants of prospective clinical trials on early breast cancer.

Patients with prospective data collection will be informed about the registry by the treating

physician at the study site. After written informed consent (which may already be included in

the main and/or biomaterial informed consent form of the respective clinical study) for data

and biomaterial collection, the registration form will be filled out completely within the

GBG electronic data capture system (MEDCODES®). Inclusion and registration can take place

after informed consent of the patient. However, documentation of follow-up should start after

the regular end of study or with the start of the follow-up period, as defined in the

respective study protocol.

A correlation of the follow-up registry database with the respective study databases is

possible via the patient identification number of the participant. Consequently, the

long-term effects of the study therapy can be calculated per therapy group, and the

effectiveness can be correlated with possible late-onset toxicities.

Post-study long-term outcome follow-up will be assessed according to local/national

guidelines for standard follow-up examinations and post-treatment surveillance. Data should

be documented at least once a year in the registry.

Relapse and safety assessment will be performed, and survival status will be collected in all

registered patients. Here, the investigator may conduct evaluations or assessments within

regular follow-up visits. However, telephone contact or contact in writing with the patient

or treating physician or relatives in case of death is also acceptable. Imaging tests (e.g.,

mammography and/or staging workup) are recommended according to local/national guidelines for

follow-up and in case of symptoms suspicious for locoregional or distant relapse.

Information to be collected include:

- Date and site of first non-invasive local recurrence, first invasive local recurrence,

first contralateral breast recurrence, first regional recurrence, first distant

recurrence

- Date and diagnosis of secondary malignancies

- Date and cause of deaths

- Pregnancies after study participation and their respective outcome

- Anti-hormonal therapies in HR+ breast cancer patients

- Further anti-cancer treatments after study participation

- Long-term adverse drug reactions of the respective study treatments

In case of disease recurrence, it is recommended to confirm diagnosis by histological

examination. If performed, an FFPE tumor tissue block from the metastatic lesion should be

provided to GBG.

It is allowed and recommended to register patients in parallel in the GBG self-reporting

registry (available only in German) that will allow follow-up and long-term efficacy

evaluations beyond the end of the respective study by the patients themselves.

STATISTICS

This is an observational study for collection of long-term safety and efficacy parameters of

former GBG study participants. As long-term outcomes and late-onset toxicities are also

secondary objectives in all prospective clinical studies of the GBG, statistical methods will

adhere as much as possible to methods described in the respective clinical trial protocols.

For the analysis, data from the corresponding clinical trials (e.g., baseline

characteristics, short-time efficacy, and toxicity parameters, already collected follow-up

data, etc.) will be merged with the registry data.

DATA HANDLING, MANAGEMENT AND QUALITY ASSURANCE

The GBG EDC system MEDCODES® will be maintained by GBG Forschungs GmbH for all study sites.

Data management, which comprises CRF design, database and application hosting, data entry,

and data validation, will be performed by GBG Forschungs GmbH for all study sites. GBG

Forschungs GmbH will provide the investigator site with the web base EDC system MEDCODES®

that is validated and conforms to 21 CFR Part 11 requirements. Investigator site staff will

not be given access to MEDCODES® until they have been trained on the EDC system.

Visual and computerized methods of data validation are applied in order to ensure accurate,

consistent, and reliable data for the subsequent analyses.

All communication between MedCODES® and the clients is securely encrypted (Secure HTTP).

In order to protect patient confidentiality, each participating patient is assigned a unique

GBG patient identification number. Instead of the true patient identity, the pseudonym is

used in all communication between the trial site and the GBG Forschungs GmbH. A correlation

of the follow-up registry database with the respective study databases is possible via the

patient identification number of the participant.

Every user is provided with a unique username and a unique password. Every user is assigned

to a user group which represents their role in the CRF workflow. Access control is based on

user name, group. Therefore, users can only access those datasets necessary for them to

fulfill their role in the CRF workflow ("need to know basis").

Ein-/Ausschlusskriterien

Inclusion criteria:

- Participation and treatment in a GBG clinical trial for early breast cancer.

- Prospective registration: Written informed consent according to local regulatory

requirements prior to data and biomaterial collection.

Exclusion criteria:

- Participation and treatment in a non-GBG clinical trial for early breast cancer.

- Patients with advanced or metastatic breast cancer who have participated and received

treatment in a GBG clinical trial.

Studien-Rationale

Primary outcome:

1. Disease-free survival (DFS) (Time Frame - 10 years):
Time period between randomization and first event (ipsi- or contralateral (non-) in-breast or loco-regional recurrence, distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause, invasive contralateral breast cancer, second primary invasive cancer (non-breast))

2. Invasive disease-free survival (iDFS) (Time Frame - 10 years):
Time period between randomization and first event (ipsi- or contralateral invasive in-breast or loco-regional recurrence, distant recurrence, death from breast cancer, death from non-breast cancer cause, death from unknown cause, invasive contralateral breast cancer, second primary invasive cancer (non-breast))

3. Distant disease-free survival (DDFS) (Time Frame - 10 years):
Time period between randomization and diagnosis of any distant recurrence of disease, any second primary invasive cancer (non-breast) or death due to any cause, whichever occurs first

4. Locoregional recurrence-free survival (LRRFS) (Time Frame - 10 years):
Time period between randomization and diagnosis of any loco-regional (ipsilateral breast (invasive or DCIS), local/regional lymph nodes) recurrence of disease, any invasive contralateral breast cancer or death due to any cause, whichever occurs first

5. Overall survival (OS) (Time Frame - 10 years):
Time period between randomization and death of any cause

6. Other primary outcome measures (Time Frame - 10 years):
Other study-specific long-term survival endpoints may be defined in the respective study protocol or statistical analysis plan (SAP)

Secondary outcome:

1. Long-term toxicity (Time Frame - 10 years):
Frequency and severity of long-term toxicity associated with study treatment are graded by the current NCI Common Terminology Criteria for Adverse Events version (NCI-CTCAE) or according to the respective study protocol or statistical analysis plan (SAP)

2. Anti-cancer therapies (Time Frame - 10 years):
Anti-cancer therapies including anti-hormonal therapy in hormone receptor positive (HR+) breast cancer after study participation are analyzed descriptively

3. Pregnancies (Time Frame - 10 years):
Pregnancies after study participation and their outcome are analyzed descriptively.

4. Impact of study treatment on Quality of Life (QoL) (Time Frame - 10 years):
In this registry, two questions on content on quality of life and degree of bother by side-effects are used

Quelle: ClinicalTrials.gov

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