Novel Therapies in
Metastatic Breast Cancer Overview
Abemaciclib
Abemaciclib is a kinase inhibitor indicated:
(1) in combination with an aromatase inhibitor
as initial endocrine-based therapy for the
treatment of postmenopausal women
with hormone receptor (HR)-positive,
human epidermal growth factor receptor
2 (HER2)-negative advanced or metastatic
breast cancer.
(2) in combination with fulvestrant for the
treatment of women with hormone
receptor (HR)-positive, human epidermal
growth factor receptor 2 (HER2)-negative
advanced or metastatic breast cancer with
disease progression following endocrine
therapy.
(3) as monotherapy for the treatment of adult
patients with HR-positive, HER2-negative
advanced or metastatic breast cancer with
disease progression following endocrine
therapy and prior chemotherapy in the
metastatic setting.
Can be taken with or without food; the
recommended starting dose in combination
with fulvestrant is 150 mg twice daily; the
recommended starting dose as monotherapy
is 200 mg twice daily. Dosing interruption and/
or dose reductions may be required based on
individual safety and tolerability.
The most common adverse reactions
(incidence of 20% or greater) are diarrhea,
neutropenia, nausea, abdominal pain,
infection, fatigue, anemia, leukopenia,
decreased appetite, vomiting, headache,
and thrombocytopenia. Additional adverse
reactions to monitor for include hepatobiliary
toxicity and venous thrombosis.
Palbociclib
Indication
Palbociclib is a kinase inhibitor indicated for
the treatment of hormone receptor (HR)-
positive, human epidermal growth factor
receptor 2 (HER2)-negative advanced or
metastatic breast cancer in combination with:
(1) an aromatase inhibitor as initial
endocrine based therapy in
postmenopausal women
(2) fulvestrant in women with disease
progression following endocrine
therapy.
Dosing and Administration
Capsules are taken orally with food; the
recommended dose is a 125 mg capsule taken
orally once daily for 21 consecutive days,
followed by 7 days off treatment, comprising
a complete cycle of 28 days in combination
with an aromatase inhibitor or fulvestrant.
Patients should be encouraged to take their
dose at approximately the same time each
day. If the patient vomits or misses a dose,
an additional dose should not be taken, and
the next prescribed dose should be taken at
the usual time. Dosing interruption and/or
dose reductions are recommended based on
individual safety and tolerability.
Adverse Reactions
The most common adverse reactions
(incidence of 10% or greater) are neutropenia,
infection, leukopenia, fatigue, nausea,
stomatitis, anemia, alopecia, diarrhea,
thrombocytopenia, rash, vomiting, decreased
appetite, asthenia, and pyrexia.
Ribociclib
Ribociclib is a kinase inhibitor indicated in
combination with an aromatase inhibitor
as initial endocrine-based therapy for the
treatment of postmenopausal women with
hormone receptor (HR)-positive, human
epidermal growth factor receptor 2 (HER2)-
negative advanced or metastatic breast cancer
Tablets are taken orally with or without
food; in combination with letrozole, the
recommended starting dose is 600 mg orally
(three 200 mg tablets) taken once daily for
21 consecutive days, followed by 7 days off
treatment. Dose interruption, reduction, and/
or discontinuation may be required, based on
individual safety and tolerability.
The most common adverse reactions
(incidence of 20% or greater) are
neutropenia, nausea, fatigue, diarrhea,
leukopenia, alopecia, vomiting, constipation,
headache, and back pain. Additional adverse
reactions to monitor for include QTc
prolongations and hepatobiliary toxicity.
Updated 6/6/18