An observational study in Breast Cancer, sponsored by iOMEDICO AG. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by iOMEDICO AG · Observational
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Among 11 studies in Breast Neoplasms by iOMEDICO AG — 2 open to participants now, 2 under way, none of them phase 3. Breast Neoplasms · iOMEDICO AG.
Among the 11 studies in Breast Neoplasms by iOMEDICO AG, this one is the only one that started in 2017, is one of 6 observational ones, and was the 7th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →2 of the 11 studies in Breast Neoplasms by iOMEDICO AG are open now, in 1 country. Recruiting first, the newest first:
iOMEDICO AG · Sites in Germany
Ages 18+ · Women only
By country, each count listing its studies:
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 6,150 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Median enrollment 388 across the 5 interventional studies, 603 across the 6 observational. Of the 9 that completed or were terminated, 0 (0%) have results posted.
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iOMEDICO AG is the lead sponsor of 53 studies on the registry; 14 are open to participants now.
None of the studies under way reaches primary completion within a year.
Among the 11 studies in Breast Neoplasms by iOMEDICO AG, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
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.
Adult female and male patients with breast cancer starting first systemic treatment for EBC or ABC.
EBC cohort:
ABC cohort I (prospective):
ABC cohort II (retrospective):
Prospective cohorts:
All cohorts:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with HER2-positive advanced breast cancer
Patients with triple negative advanced breast cancer
Patients with HR positive, Her2 negative advanced breast cancer
Patients with HER2 positive early breast cancer
Patients with triple negative early breast cancer
Patients with HR positive, HER2 negative early breast cancer
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.
Time frame: 5 years
Best Response
Documentation of response rates per line of treatment.
Time frame: 5 years
Progression-free survival
Documentation of progression-free survival per line of treatment.
Time frame: 5 years
Overall survival
Documentation of date of death.
Time frame: 5 years
Health-related quality of life (Patient-reported outcome)
EORTC QLQ-C30 core questionnaire and additional items.
Time frame: 3.5 years
Disease-free survival
Documentation of disease-free survival.
Time frame: 5 years
Plan to share: No
Started Dec 2017 (actual). Primary completion is estimated for Jun 2032, 174 months after the start.
Of 189 industry-sponsored observational studies under Breast Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 70. This study's planned 174 months is above that.
Counting every sponsor, half of 1,381 studies reached it within 55 months; a quarter within 25 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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