Palbociclib is not a treatment for every type of breast cancer. Its use depends on tumor biology, disease stage, previous therapy, biomarkers and the applicable regulatory authorization.
HR-positive, HER2-negative advanced or metastatic breast cancer
Current U.S. labeling includes IBRANCE for adults with HR-positive, HER2-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy or with fulvestrant following disease progression on endocrine therapy.
PIK3CA-mutated disease
Current U.S. labeling also includes palbociclib in combination with inavolisib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive/HER2-negative locally advanced or metastatic breast cancer following recurrence on or after completing adjuvant endocrine therapy, with the mutation detected using an FDA-authorized test.
HR-positive, HER2-positive metastatic disease
In June 2026, FDA expanded palbociclib’s U.S. role to include maintenance treatment for adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment, in combination with trastuzumab, with or without pertuzumab, and endocrine therapy.
This is distinct from the HR-positive/HER2-negative indications and should not be merged with them.
European Union indication
The EMA currently describes Ibrance for HR-positive/HER2-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant following prior endocrine therapy. In pre- or perimenopausal women, endocrine therapy should be combined with an LHRH agonist.
Treatment setting
Palbociclib may therefore be used in different treatment settings depending on:
- HR status
- HER2 status
- Disease stage
- Previous endocrine therapy
- Disease progression
- PIK3CA mutation status where relevant
- Menopausal status
- Combination treatment
- Local regulatory authorization
Approved versus investigational use
Clinical studies involving palbociclib do not automatically establish an approved indication. A patient should not use palbociclib for an investigational indication based solely on research results.