NCT05131893

Neoadjuvant Treatment of Breast Cancer

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: National Institute of Oncology, Hungary · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Tamoxifen	endocrine therapy
DRUG	Goserelin	endocrine therapy
DRUG	Letrozole 2.5Mg Tab	endocrine therapy
DRUG	Epirubicin	chemotherapy
DRUG	cyclophosphamide	chemotherapy
DRUG	Docetaxel	chemotherapy
DRUG	paclitaxel	chemotherapy
DRUG	trastuzumab	biological treatment
DRUG	pertuzumab	biological treatment
DRUG	Capecitabine	chemotherapy

Timeline

• Start date: 2022-03-01
• Primary completion: 2023-03-01
• Completion: 2031-12-01
• First posted: 2021-11-23
• Last updated: 2021-11-23

Locations

1 site across 1 country: Hungary

Regulatory

• FDA-regulated drug study