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Observational investigation of participants who are given neoadjuvant treatment for invasive breast cancer. The scope of the study is to collect information on standardized treatment results, to explore the causes of dose modification and its effect on efficacy, to explore potential prognostic factors, and to explore the long-term side effects of different treatment modalities.
The purpose of the study is based on the uniform application of international guidelines in Hungarian conditions. The standardized circumstances may lead to optimization of neoadjuvant therapy, it may facilitate subsequent data analysis, provide a basis for prospective clinical questions, and demonstrate improvement in pathologic complete remission (pCR) and overall survival (OS) compared to historical control. It may make possible to collect real-life data on each therapeutic option: efficacy, side effects, dose reduction, dose intensity, long-term consequences. The main scope is to collect prospective data to explore prognostic and predictive factors. The auxiliary aim is the assessment and comparison of quality of life during specific treatments and their side effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LuminalA |
|
| |
| LuminalB (Her2 negative) |
|
| |
| Her2 positive |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | endocrine therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| pathological complete remission rate | no invasive tumor in breast and axilla | 3 year, maximum |
| Measure | Description | Time Frame |
|---|---|---|
| invasive disease-free survival | from the beginning of neoadjuvant therapy to the first appearance of invasive tumor or death | 10 years |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) |
| Measure | Description | Time Frame |
|---|---|---|
| dose density assessment | actual dose / planned dose | 3 year, maximum |
| investigate the potential prognostic effect of neutrophil/lymphocyte ratio | study of the role of neutrophil/lymphocyte ratio (NLR) at baseline, before the 3. cycle, and before surgery. NLR is measured from the qualitative blood count as the absolute neutrophil count divided by the absolute lymphocyte count |
Inclusion Criteria:
Participant over 18 years of age .
Histologically confirmed (core biopsy) invasive breast tumor.
Tumor extent for the indication:
Appropriate general condition: ECOG 0-1
Proper organ function
Exclusion Criteria:
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Breast cancer patients for whom neoadjuvant therapy is proposed by multidisciplinary team
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| gabor Rubovszky | Contact | +3612248600 | 3442 | garub@oncol.hu |
| Balazs Madaras | Contact | +3612248600 | madarasb@oncol.hu |
| Name | Affiliation | Role |
|---|---|---|
| Gabor Rubovszky | NIO Hungary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Oncolgy | Budapest | 1122 | Hungary |
The individual participant data are not planned to be shared with other researchers but will be available upon request except personal data
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D017273 | Goserelin |
| D000077289 | Letrozole |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D000077143 | Docetaxel |
| D017239 | Paclitaxel |
| D000068878 | Trastuzumab |
| C485206 | pertuzumab |
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Triple-negative breast cancer |
|
|
| Goserelin | Drug | endocrine therapy |
|
| Letrozole 2.5Mg Tab | Drug | endocrine therapy |
|
|
| Epirubicin | Drug | chemotherapy |
|
| cyclophosphamide | Drug | chemotherapy |
|
| Docetaxel | Drug | chemotherapy |
|
| paclitaxel | Drug | chemotherapy |
|
| trastuzumab | Drug | biological treatment |
|
| pertuzumab | Drug | biological treatment |
|
| Capecitabine | Drug | chemotherapy |
|
Global health status, functional and symptom scales survey using the EORTC QLQ-C30 questionnaire before cycle 1, before cycle 4, after the last neoadjuvant chemotherapy, and before surgery, 1 year after chemotherapy
| 4 years |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ BR45) | Breast cancer-specific functional scales and symptom scales survey using the EORTC QLQ BR45 questionnaire before cycle 1, before cycle 4, after the last neoadjuvant chemotherapy, and before surgery, 1 year after chemotherapy | 4 years |
| evaluation of side effects | to collect information all potential complaints and adverse event during and after treatment | 10 years |
| 10 years |
| investigate the potential prognostic effect of monocyte/lymphocyte ratio | monocyte/lymphocyte ratio (MLR) at baseline, before the 3. cycle, and before surgery. MLR is measured from the qualitative blood count as the absolute monocyte count divided by the absolute lymphocyte count | 10 years |
| investigate potential prognostic factors, CRP | C-reactive protein serum level befor start of chemotherapy | 10 years |
| investigate potential prognostic factors | circulating free-DNA at baseline, before 3. cycle, before surgery | 10 years |
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004317 | Doxorubicin |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |