Breast Cancer Registry Platform

Studien-Informationen Einschlusskriterien Studien-Rationale Studien-Arme

Rekrutierend

NCT-Nummer:
NCT03417115

Studienbeginn:
Dezember 2017

Letztes Update:
12.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
iOMEDICO AG

Collaborator:
-

Studienleiter

Norbert Marschner, MD
Study Chair
Praxis für interdisziplinäre Onkologie & Hämatologie

Kontakt

Lisa Kruggel
Kontakt:
Phone: +49 761 15242-0
E-Mail: info@iomedico.com» Kontaktdaten anzeigen

Ursula Dietrich
Kontakt:
Phone: +49 761 15242-0
E-Mail: info@iomedico.com» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Multiple sites all over germany
Multiple Locations
GermanyRekrutierend» Google-Maps
Ansprechpartner:
iOMEDICO AG
Phone: +49 761 15242-0
E-Mail: info@iomedico.com» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

OPAL is a national, observational, prospective, longitudinal, multicenter cohort study (tumor

registry platform) with the purpose to record information on the antineoplastic treatment of

breast cancer in Germany. The registry will follow patients for up to five years. It will

identify common therapeutic sequences and changes in the treatment of the disease. At

inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous

treatments are collected. During the course of observation data on all systemic treatments,

radiotherapies, surgeries, and outcome are documented.

Health-related quality of life in patients with breast cancer will be evaluated for up to

five years.

Ein-/Ausschlusskriterien

Inclusion Criteria:

EBC cohort:

- Female and male patients with early breast cancer (stage I-III defined as breast

cancer that has not spread beyond the breast or the axillary lymph nodes)

- Patients at the start of their initial systemic treatment for EBC, i.e. at start of

neoadjuvant treatment for patients receiving neoadjuvant thera-py or at start of

adjuvant treatment if no neoadjuvant therapy is given. Treatment can be cytotoxic,

endocrine, or targeted substances, what-ever was given first

ABC cohort:

- Female and male patients with advanced breast cancer (stage IV defined as synchronous

or metachronous diagnosis of distant metastases at inclusion)

- Patients at the start of their initial first-line systemic treatment for ABC, which

can be cytotoxic, endocrine or targeting a specific signaling pathway, whatever is

given first

All cohorts:

- Written informed consent

- Patients participating in the PRO module: signing of informed consent form and

completion of baseline questionnaire before start of initial systemic treatment

for EBC or systemic first-line treatment for ABC

- Patients not participating in the PRO module: within six weeks after start of

initial systemic treatment for EBC or systemic first-line treatment for ABC

- Age ≥ 18 years

Exclusion Criteria:

- Patients with prior systemic therapy (cytotoxic, endocrine, or targeted) for EBC or

ABC

- Patients who do not receive any systemic therapy for EBC or ABC

Studien-Rationale

Primary outcome:

1. Treatment reality (Time Frame - 5 years):
Description of treatment reality (Course of systemic treatments and sequential treatments) applied in German routine practice measured as the frequency of the various systemic treatments applied per line of therapy.

Secondary outcome:

1. Best Response (Time Frame - 5 years):
Documentation of response rates per line of treatment.

2. Progression-free survival (Time Frame - 5 years):
Documentation of progression-free survival per line of treatment.

3. Overall survival (Time Frame - 5 years):
Documentation of date of death.

4. Health-related quality of life (Patient-reported outcome) (Time Frame - 3.5 years):
EORTC QLQ-C30 core questionnaire and additional items.

5. Disease-free survival (Time Frame - 5 years):
Documentation of disease-free survival.

Studien-Arme

Advanced breast cancer - Her2 positive
Patients with HER2-positive advanced breast cancer
Advanced breast cancer - triple negative
Patients with triple negative advanced breast cancer
Advanced breast cancer - HR positive, Her2 negative
Patients with HR positive, Her2 negative advanced breast cancer
Early breast cancer - HER2 positive
Patients with HER2 positive early breast cancer
Early breast cancer - triple negative
Patients with triple negative early breast cancer
Early breast cancer - HR positive, HER2 negative
Patients with HR positive, HER2 negative early breast cancer

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Breast Cancer Registry Platform"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!