Neoadjuvant Treatment of Breast Cancer

Официальное название

Neoadjuvant Treatment of Breast Cancer - a Prospective Observational Study, PANnon ONCology (PANONC) Group Non-commercial Clinical Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Tamoxifen
  endocrine therapy
• Препарат Goserelin
  endocrine therapy
• Препарат Letrozole 2.5Mg Tab
  endocrine therapy
• Препарат Epirubicin
  chemotherapy
• Препарат cyclophosphamide
  chemotherapy
• Препарат Docetaxel
  chemotherapy
• Препарат paclitaxel
  chemotherapy
• Препарат trastuzumab
  biological treatment
• Препарат pertuzumab
  biological treatment
• Препарат Capecitabine
  chemotherapy

Первичные конечные точки

• pathological complete remission rate [Срок оценки: 3 year, maximum]

Вторичные конечные точки (4)

• invasive disease-free survival [Срок оценки: 10 years]
• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) [Срок оценки: 4 years]
• European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Breast Cancer Module (EORTC QLQ BR45) [Срок оценки: 4 years]
• evaluation of side effects [Срок оценки: 10 years]

Критерии участия

Критерии включения

• Participant over 18 years of age .
• Histologically confirmed (core biopsy) invasive breast tumor.
• 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.
• Appropriate general condition: ECOG 0-1
• 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

Критерии исключения

• 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.
• Pregnancy or if the participant does not agree to use an appropriate non-hormonal method of contraception.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Венгрия · 1 центр

• National Institute of Oncolgy — Budapest

Идентификаторы

NCT: NCT05131893 · PANONC-1 Version: 1.1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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