Romanian Consensus Statement for Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer (HR+/HER2– mBC) and Triple-Negative Metastatic Breast Cancer (mTNBC)

TL;DR

This paper presents national treatment guidelines for two types of metastatic breast cancer in Romania, developed by oncologists and widely accepted by medical professionals.

Contribution

The paper introduces Romania-specific consensus guidelines for HR+/HER2– and triple-negative metastatic breast cancer, adapted from international standards and validated through a survey.

Findings

A modified Delphi survey of 61 oncologists showed over 90% agreement with the proposed treatment recommendations.

Key recommendations include mandatory biopsy at metastasis and the use of modern therapies like CDK4/6 inhibitors and immunotherapies.

The guidelines emphasize systematic toxicity monitoring and integrated supportive care.

Abstract

Breast cancer is the most common malignant disease among Romanian women, and the number of deaths remains among the highest in Europe. This consensus document provides national standards for treating two metastatic types of breast cancer without human epidermal growth factor receptor 2 (HER2) overexpression: hormone receptor-positive/HER2-negative and triple-negative metastatic disease. A scientific board of 11 oncologists, in collaboration with the Romanian National Society for Medical Oncology, adapted international guidelines to fit Romanian realities and then assessed acceptance among medical oncologists through a survey of 61 oncologists. The recommendations include: repeating biopsy and key biomarker tests at metastasis, utilizing modern targeted and immunotherapies when appropriate, carefully monitoring and managing side effects, and providing strong supportive and palliative care. Sixty-one oncologists completed the survey, and an over 90% agreement was achieved, supporting these recommendations as the new national standard.

Breast cancer (BC) is the most common malignant disease in women in Romania, with incidence and mortality rates among the highest in Europe. This consensus statement aims to ensure equitable access to care for human epidermal growth factor receptor 2-negative metastatic BC (HR+/HER2– mBC) and triple-negative mBC (mTNBC) in Romania. Between December 2024 and June 2025, a scientific board of 11 oncologists, in collaboration with the Romanian National Society for Medical Oncology (SNOMR), developed national recommendations based on ESMO/NCCN/ABC guidelines, clinical expertise, and local conditions. A modified Delphi survey was conducted among medical oncologists to evaluate acceptance of recommendations with greatest clinical impact. Key recommendations included: mandatory biopsy at metastasis with ER/PgR/HER2 retesting, HER2-low assessment, and molecular profiling (BRCA, PIK3CA, AKT1/PTEN, ESR1, plus PD-L1 testing in mTNBC); for HR+/HER2– mBC, first-line endocrine therapy plus CDK4/6 inhibitor, followed by targeted agents, chemotherapy, or antibody–drug conjugates based on progression and visceral crisis; for mTNBC, first-line immune checkpoint inhibitor plus chemotherapy in PD-L1-positive, PARP inhibitors in BRCA-positive patients, and sacituzumab-govitecan or trastuzumab-deruxtecan later; systematic toxicity monitoring; and integrated supportive and palliative care. Sixty-one oncologists completed the survey, with >90% overall agreement, suggesting broad acceptance of recommendations as Romania’s national standard for mBC care.

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