Recommendation 3.1
➤ A nonsteroidal AI and a CDK4/6 inhibitor should be offered to
postmenopausal patients and to premenopausal patients combined
with chemical ovarian function suppression, and to male patients (with
a gonadotropin-releasing hormone analog), with treatment-naïve HR-
positive MBC. (Strong recommendation; EB-B-H)
Recommendation 3.2
➤ Fulvestrant and a CDK4/6 inhibitor should be offered to patients
with progressive disease during treatment with AIs (or who develop
a recurrence within one year of adjuvant AI therapy) with or without
one line of prior chemotherapy for metastatic disease, or as first-line
therapy. Treatment should be limited to those without prior exposure to
CDK4/6 inhibitors in the metastatic setting. (Strong recommendation;
EB-B-H)
Recommendations Unchanged from 2016 Guideline
➤ Postmenopausal women with metastatic, HR-positive breast cancer
should be offered AIs as first-line endocrine therapy.
➤ Combination hormone therapy with fulvestrant with a loading dose
followed by 500 mg every 28 days combined with a nonsteroidal
aromatase inhibitor may be offered for patients with metastatic breast
cancer without prior exposure to adjuvant endocrine therapy
➤ Premenopausal women with metastatic hormone receptor positive
breast cancer should be offered ovarian suppression/ablation in
combination with hormonal therapy. Ovarian suppression with either
gonadotropin releasing hormone (GnRH) agonists or ablation with
oophorectomy appears to achieve similar results in metastatic
breast cancer. 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/ablation alone although combination therapy
is preferred. Treatment should be based on the biology of the tumor
and the menopausal status of the patient with careful attention paid to
production of ovarian estrogen.
➤ Treatment should take into account the biology of the tumor and the
menopausal status of the patient with careful attention paid to ovarian
production of estrogen.
➤ The choice of second-line hormonal therapy should take into account
prior treatment exposure and response to previous endocrine therapy.
