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
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 design
Treatments tested in this trial
- Tamoxifen
- Goserelin
- Letrozole 2.5Mg Tab
- Epirubicin
- cyclophosphamide
- Docetaxel
- paclitaxel
- trastuzumab
- pertuzumab
- Capecitabine
Treatment groups
300 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov