Neoadjuvant Treatment of Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05131893
• Other study ID #: PANONC-1 Version: 1.1
• Status: Not yet recruiting
• Start date: March 2022
• Est. completion date: December 2031

Study information

• Verified date: November 2021
• Source: National Institute of Oncology, Hungary
• Contact: gabor Rubovszky
• Phone: +3612248600
• Email: garub[@]oncol.hu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2031
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Hungary	National Institute of Oncolgy	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Oncology, Hungary

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	dose density assessment	actual dose / planned dose	3 year, maximum
Other	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	10 years
Other	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
Other	investigate potential prognostic factors, CRP	C-reactive protein serum level befor start of chemotherapy	10 years
Other	investigate potential prognostic factors	circulating free-DNA at baseline, before 3. cycle, before surgery	10 years
Primary	pathological complete remission rate	no invasive tumor in breast and axilla	3 year, maximum
Secondary	invasive disease-free survival	from the beginning of neoadjuvant therapy to the first appearance of invasive tumor or death	10 years
Secondary	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	4 years
Secondary	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
Secondary	evaluation of side effects	to collect information all potential complaints and adverse event during and after treatment	10 years