Breast Cancer
Conditions
Keywords
Neoadjuvant systemic therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGTamoxifen
endocrine therapy
DRUGGoserelin
endocrine therapy
endocrine therapy
DRUGEpirubicin
chemotherapy
DRUGcyclophosphamide
chemotherapy
DRUGDocetaxel
chemotherapy
DRUGpaclitaxel
chemotherapy
DRUGtrastuzumab
biological treatment
DRUGpertuzumab
biological treatment
DRUGCapecitabine
chemotherapy
Sponsors
National Institute of Oncology, Hungary
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Participant over 18 years of age . 2. Histologically confirmed (core biopsy) invasive breast tumor. 3. Tumor extent for the indication: * regression must be achieved for radical surgical removal or * regression is required for breast-conserving surgery or * if hormone receptor (HR)-positive and Her2-: stage IIB (cT2N1 or cT3NO) - IIIC, * if HR-negative: stage IIA (cT2N0 or cT0-1N1) - IIIC Note: In the case of a locally advanced, irresectable case, if the possibility of radical surgery later is a realistic goal, the participant may be included in the study. 4. Appropriate general condition: ECOG 0-1 5. Proper organ function * Neutrophil count ≥ 1.5 G / l, platelet count ≥ 100 G / l, hemoglobin ≥ 10 g / dl * Alanine aminotransferase (ALT) / aspartate aminotransferase (AST) is less than 1.5 times the upper limit of the normal range * bilirubin less than 1.5 times the upper limit of the normal range (except Gilbert's disease, where less than 3 times) * creatinine less than 1.5 times the upper limit of the normal range or estimated glomerular filtration rate (eGFR) higher than 60 ml / min
Exclusion criteria
1. Proven or suspected distant metastasis. 2. No staging studies have been performed: at least chest x-ray, abdominal ultrasound. It is preferred to perform CT from the chest, abdomen, pelvic regions and bone isotope, or PET / CT if possible in case of lymph node involvement. 3. Known significant heart disease: major arrhythmia or significant conduction defect (grade 2 or more), infarction or unstable angina within 6 months, cardiac collapse without appropriate therapy, long QT syndrome, heart failure (≥New York Heart Association/NYHA II) 4. Other severe acute or chronic conditions (organic or psychiatric illness, laboratory abnormality) that, in the opinion of the treating physician, result in an unacceptable increase in the risk of chemotherapy and are contraindicated in routine clinical practice. 5. Pregnancy or if the participant does not agree to use an appropriate non-hormonal method of contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological complete remission rate | 3 year, maximum | no invasive tumor in breast and axilla |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | 4 years | 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 |
| European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ BR45) | 4 years | 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 |
| evaluation of side effects | 10 years | to collect information all potential complaints and adverse event during and after treatment |
| invasive disease-free survival | 10 years | from the beginning of neoadjuvant therapy to the first appearance of invasive tumor or death |
Other
| Measure | Time frame | Description |
|---|---|---|
| investigate potential prognostic factors | 10 years | circulating free-DNA at baseline, before 3. cycle, before surgery |
| dose density assessment | 3 year, maximum | actual dose / planned dose |
| investigate the potential prognostic effect of neutrophil/lymphocyte ratio | 10 years | 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 |
| investigate the potential prognostic effect of monocyte/lymphocyte ratio | 10 years | 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 |
| investigate potential prognostic factors, CRP | 10 years | C-reactive protein serum level befor start of chemotherapy |
Countries
Hungary
Contacts
Primary Contactgabor Rubovszky
Backup ContactBalazs Madaras
Outcome results
None listed