Guidelines for the treatment of ​ HR+/HER2- mBC

Endocrine therapy (ET) is the current recommended 1st line treatment for women​ with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer (HR+/HER2- mBC),2-3 even in the presence of visceral metastasis.*2​ Chemotherapy (CT) is recommended to be reserved for immediately life-threatening/rapidly progressive disease or concern/proof of endocrine resistance.2-3​

​IBRANCE® + letrozole/fulvestrant is recommended by various international guidelines as a treatment option for HR+/HER2- mBC, including:3​


IBRANCE® may be offered in combination with:​​

• AIs or fulvestrant 500 mg as 1st line therapy for post- and pre-menopausal women (with ovarian suppression) (type: evidence based, benefits outweigh harms; evidence quality: high; strength of recommendation: strong)¿3

• Fulvestrant 500 mg as 2nd line therapy for post- and pre-menopausal women (with continued ovarian suppression), even after one line of CT (type: evidence based, benefits outweigh harms; evidence quality: moderate; strength of recommendation: intermediate)3

¿Although no data exist at present, any AI could be substituted depending on individual tolerance.​


CDK 4/6 Inhibitors Recommendations: 

  • In addition to  an AI ,in patients naïve or pre-exposed to ET, provided a signifcant improvement in median PFS with an acceptable toxicity profile and is therefore one of the preferred treatment options for pre- and peri-menopausal women with OFS/OFA, men (preferably with LHRH agonist)  and post-menopausal women. QoL was comparable to that with ET alone. 
  • In addition to Fulvestrant in patients previously exposed to ET provided a significant improvement in median PFS as well as an improvement in QoL and is one of the preferred treatment options, if a CDK 4/6 inhibitor was not previously used for pre-/peri-menopausal women with OFS/OFA and post-menopausal women and men. 

*Not to be confused with visceral crisis, defined as severe organ dysfunction as assessed by signs and symptoms, laboratory studies, and rapid progression of disease. Visceral crisis is not the mere presence of visceral metastases, it implies important visceral compromise.2​

AI = Aromatase inhibitors; ASCO = American Society of Clinical Oncology; CT= chemotherapy.
ET = endocrine therapy; HR+/HER2- = hormone receptor positive, human epidermal growth factor receptor 2-negative; LHRH = luteinizing hormone-releasing hormone; mBC = metastatic breast cancer; NCCN = National Cancer Consortium Network.​



  1. IBRANCE® Summary of Product Characteristics.​
  2. Cardoso F, et al. 4th ESO-ESMO international Consensus Guidelines for ABC, . Annals of Oncology 29: 1634–1657, 2018
  3. Rugo HS, et al. J Clin Oncol. 2016;34(25):3069-3103. ​

Date of preparation: March 2020

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.