NCT03417115

Brief Summary

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study with associated satellites, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with breast cancer in Germany.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
35mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress74%
Dec 2017Apr 2029

Study Start

First participant enrolled

December 22, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 24, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 31, 2018

Completed
11.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2029

Last Updated

August 28, 2025

Status Verified

August 1, 2025

Enrollment Period

11.3 years

First QC Date

January 24, 2018

Last Update Submit

August 26, 2025

Conditions

Breast Cancer

Keywords

Breast CancerEpidemiologyRegistryHealth Services ResearchGermanyPalliative TreatmentAdjuvant TreatmentNeoadjuvant Treatment

Outcome Measures

Primary Outcomes (1)

  • Treatment reality

    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.

    5 years

Secondary Outcomes (5)

  • Best Response

    5 years

  • Progression-free survival

    5 years

  • Overall survival

    5 years

  • Health-related quality of life (Patient-reported outcome)

    3.5 years

  • Disease-free survival

    5 years

Study Arms (6)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult female and male patients with breast cancer starting first systemic treatment for EBC or ABC.

You may qualify if:

  • 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:
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Multiple sites all over germany

Many Locations, Germany

Location

Related Publications (1)

  • Thill M, Zahn MO, Welt A, Stickeler E, Nusch A, Fietz T, Rauh J, Wetzel N, Kruggel L, Janicke M, Marschner N, Harbeck N, Wockel A, Decker T; OPAL study group. Treatment and outcome in metastatic lobular breast cancer in the prospective German research platform OPAL. Breast Cancer Res Treat. 2023 Apr;198(3):545-553. doi: 10.1007/s10549-023-06882-7. Epub 2023 Feb 18.

    PMID: 36807725BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Norbert Marschner, MD

    Praxis für interdisziplinäre Onkologie & Hämatologie

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2018

First Posted

January 31, 2018

Study Start

December 22, 2017

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Last Updated

August 28, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)