Praegnant Breast Cancer: Early/Advanced/Metastatic
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorUniversity Hospital Tuebingen
About this trial
Among patients with breast cancer the subgroup of patients with metastases are considered the group of patients with the worst prognosis. Not only regard-ing therapy decisions but also with regard to quality assured healthcare and health economics this entity of patients remains a challenge.
Recently, novel advances in breast cancer therapy aim at the targeted therapy of tumor entities and identification of patients, for whom the greatest therapy benefit, and the least side effects are expected.
However molecular assessment of the patient and the tumor in the metastatic situation is not performed on a routine basis and in many cases tumor character-istics from the primary tumor are considered reliable enough to make therapy decisions for the metastatic patients. Although molecular reassessment of tu-mor characteristics from tumor material of the metastasis is recommended in national guidelines, only a minority of patients is biopsied, because of the inva-siveness of the procedure, even though biopsy related complications are reported to be rare.
With modern analytic methods from blood based biomaterial there seems to be an opportunity to correlate blood based tumor assessments with actual charac-teristics of the tumor. These include expression analysis, tumor mutation analy-sis, tumor gene copy number aberrations and others. One of the main aims of the PRAEGNANT study is therefore to establish an infrastructure for the compre-hensive analysis of tumor and metastatic molecular characteristics of the patient and the tumor.
Furthermore, health care related outcomes as well as health economics provide novel approaches for integration of patients in study conduct and health care awareness and are study aims of the PRAEGNANT study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult breast cancer patients (age ≥18 years)
Patients with breast cancer and no evidence of distant metastases with a diagnosis not longer than 91 days before study entry
Patients, who are able and willing to sign the informed consent form
Adult women aged ≥18 years
Disqualifiers
Patients who did not sign the informed consent form
Patients, who are not eligible for observation due to non-availability and/or severe comor-bidities as evaluated by the treating physician
Trial population
10,000 patients with breast cancer in the neoadjuvant and adjuvant (early breast cancer) setting independent of treatment regimen. 3500 patients with locally advanced/metastatic breast cancer in any line of treatment (e.g. 1st, 2nd, 3rd, or ≥ 4th line). A patient can only participate after providing informed consent.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Blood sampling
Procedure/SurgeryA blood sample will be taken during a routine blood draw
Treatment groups
13,500 Participants
are divided into 2 treatment groupsGroup A: Advanced/metastatic breast cancer1 intervention
Group B: Early breast cancer1 intervention
Trial outcomes
Primary outcomes
1
MBC (Metastatic Breast Cancer): Discovery of biomarkers, which predict progression free survival (PFS)
Analyses will be done separately for each therapy line. Biomarkers include gene expression profiling of the primary tumor and the corresponding metastases, somatic mutations, germline genetic variation, epigenetic changes and miRNA variation up to a total of 500,000 biomarkers.
Time frame
PFS defined as the time to the first progression after study inclusion from the last time of progression before or at study entry2
EBC (Early Breast Cancer): Assessment of disease free sur-vival (DFS)
DFS defined as the time to the first disease recurrence after study inclusion from time of primary diagnosis before or at study entry
Time frame
up to 60 monthsSecondary outcomes
1
MBC: Assessment of overall survival (OS)
OS is defined as the time to death from the date of the last progression before or at study entry.
Time frame
OS is defined as the time to death from the date of the last progression before or at study entry.2
MBC: Assessment of breast cancer specific survival (BCSS)
BCSS is defined as the time to to death due to breast cancer from the date of the last progression before or at study entry.
Time frame
Time to death from the date of the last progression before or at study entry.3
MBC: Objective response
Objective response is defined as the best-documented response to the therapy started at study entry or the last therapy started before study entry.
Time frame
up to 60 months4
MBC: Description of therapies used in the metastatic setting
Therapies will be categorized and descriptive statistics will be presented.
Time frame
after 60 months (after study completion)Other outcomes
1
Correlation of the incidence of depression with germline gentic variation and therapies and gene expression from leukocytes.
Depression Inventory values will be associated with blood biomarkers, single nucleotide polymorphisms and therapies.
Time frame
Study entry and following a change of a therapy line (event-associated, e.g. after progression) up to month 602
Correlation of gene alterations (mutations and or amplifications) and gene expres-sion between primary tumor and metastatic tumor for the prediction of side effects and prognosis.
DNA and RNA of the primary tumor will be extracted of archival formalin fixed, paraffin embedded tumor samples and analyzed mutations, mutation changes, and differentially expressed genes. Additionally, FFPE will be used for the construction of a TMA for antibody staining.
Time frame
after 60 months (after study completion)3
Correlation of gene alterations (mutations and or amplifications) and gene expres-sion between primary tumor, metastatic tumor and circulating tumor cells (CTCs).
Circulating tumor cells (CTC) from selected patients will be analyzed for mutations and gene amplifications. Findings will be compared to mutations assessed from FFPE tumor material.
Time frame
Study entry and following a change of a therapy line (event-associated, e.g. after progression) up to month 604
Correlation of gene alterations (mutations and or amplifications) between primary tumor, metastatic tumor and circulating tumor DNA.
Circulating DNA (ctDNA) will be analyzed for genetic variation and compared to mutations assessed from FFPE tumor material.
Time frame
after 60 months (after study completion)Sponsors and contacts
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Source ClinicalTrials.gov