Neoadjuvant Treatment of Breast Cancer

ConditionBreast Cancer

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-100

SponsorNational Institute of Oncology, Hungary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant over 18 years of age .

Histologically confirmed (core biopsy) invasive breast tumor.

regression must be achieved for radical surgical removal or

regression is required for breast-conserving surgery or

Disqualifiers

Proven or suspected distant metastasis.

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.

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)

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.

Trial population

Breast cancer patients for whom neoadjuvant therapy is proposed by multidisciplinary team

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Tamoxifen
Drug
endocrine therapy
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

Treatment groups

300 Participants

are divided into 4 treatment groups

Group A: LuminalA3 interventions

Group B: LuminalB (Her2 negative)8 interventions

Group C: Her2 positive9 interventions

Group D: Triple-negative breast cancer5 interventions

Trial outcomes

Primary outcomes

pathological complete remission rate

no invasive tumor in breast and axilla

Time frame

3 year, maximum

Secondary outcomes

invasive disease-free survival

from the beginning of neoadjuvant therapy to the first appearance of invasive tumor or death

Time frame

10 years

European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

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

Time frame

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

Time frame

4 years

evaluation of side effects

to collect information all potential complaints and adverse event during and after treatment

Time frame

10 years

Other outcomes

dose density assessment

actual dose / planned dose

Time frame

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

Time frame

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

Time frame

10 years

investigate potential prognostic factors, CRP

C-reactive protein serum level befor start of chemotherapy

Time frame

10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Institute of Oncology, Hungary

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: