Treatment
➤ Treatment recommendations in the metastatic or advanced setting should
be offered on the basis of type of adjuvant treatment, disease-free interval,
and extent of disease at the time of recurrence (Figures 1 and 2). A specific
hormonal agent may be used again if recurrence occurs >12 months from
the last treatment (Strong Recommendation; EB/CB-B-H).
Clinical Trials
➤ Use of additional biomarkers is experimental and should be reserved for
selection of treatment in clinical trials. There is no routine clinical role for
genomic or expression profiling in the selection of treatment for HR+ MBC
(Moderate Recommendation; CB-B-L).
➤ Patients should be encouraged to consider enrolling in clinical trials,
including those receiving treatment in the first-line setting (Moderate
Recommendation; EB/CB-B-I).
• Multiple clinical trials are ongoing or planned, with a focus on improving response to
hormone therapy in metastatic disease.
First-Line Therapy
➤ Postmenopausal women with HR+ MBC should be offered aromatase
inhibitors (AIs) as first-line endocrine therapy (Figure 1) (Strong
Recommendation; EB-B-H).
➤ Combination hormone therapy with fulvestrant, with a loading dose
followed by 500 mg every 28 days, plus a nonsteroidal AI may be offered
to patients with MBC without prior exposure to adjuvant endocrine therapy
(Figure 1) (Moderate Recommendation; EB-B-I).
➤ Premenopausal women with HR+ MBC should be offered ovarian
suppression or ablation in combination with hormone therapy (Strong
Recommendation; EB-B-H).
• Ovarian suppression with either gonadotropin-releasing hormone (GnRH) agonists or
ablation with oophorectomy seems to achieve similar results in MBC.
• For most patients, clinicians should use guidelines for postmenopausal women to guide
the choice of hormone treatment, although sequential therapy can also be considered.
• Patients without exposure to prior hormone therapy can also be treated with tamoxifen
or ovarian suppression or ablation alone, although combination therapy is preferred
(Figure 2).
• Treatment should be on the basis of the biolog y of the tumor and the menopausal status
of the patient, with careful attention paid to production of ovarian estrogen.
