FDA-Approved Breast Cancer Treatments- MPR

FDA-Approved Breast Cancer Treatments

FDA-APPROVED BREAST CANCER TREATMENTS
Generic	Brand	Strength	Form	Adult Dose
ALKYLATING AGENTS
cyclophos– phamide	—	25mg, 50mg	tabs	1−5mg/kg/day.
cyclophos– phamide	—	500mg, 1g, 2g	pwd for IV inj after reconstitution	40−50mg/kg in divided doses over 2−5 days or 10−15mg/kg every 7−10 days or 3−5mg/kg twice weekly.
thiotepa	—	15mg	pwd for IV, intravesical, or intracavitary admin after reconstitution	0.3−0.4mg/kg IV once every 1−4wks.
ANTIBIOTICS (CYTOTOXIC)
doxorubicin	—	10mg, 20mg, 50mg	pwd for IV inj after reconstitution	Monotherapy: 60−75mg/m² every 21 days. Combination therapy: 40−60mg/m² every 21−28 days.
doxorubicin	—	2mg/mL	soln for IV inj
epirubicin	Ellence	2mg/mL	soln for IV inj	100–120mg/m² IV bolus on Day 1 of each cycle, or 2 equally divided doses on Days 1 and 8 of each cycle. Administer in repeated 3–4 week cycles for a total of 6 cycles.
ANTIESTROGEN
tamoxifen	—	10mg, 20mg	tabs	Treatment: 20–40mg/day (give doses >20mg in the AM and PM). Reduction of incidence in high-risk women or DCIS: 20mg once daily for 5yrs.
tamoxifen	Soltamox Oral Solution	10mg/ 5mL	oral soln	Metastatic: 20–40mg/day (give doses >20mg in the AM and PM). Adjuvant: 20mg daily for 5–10yrs. Reduction of incidence in high-risk women or DCIS: 20mg once daily for 5yrs.
toremifene	Fareston	60mg	tabs	60mg once daily.
ANTIMETABOLITES
capecitabine	Xeloda	150mg, 500mg	tabs	Metastatic: Give cyclically (2 weeks on, 1 week off). Take within 30mins after AM & PM meals. Monotherapy: 1250mg/m² twice daily Combination therapy: Give with docetaxel 75mg/m² IV infused over 1hr every 3wks.
fluorouracil	—	50mg/mL	soln for IV inj	12mg/kg once daily for 4 successive days; max 800mg/day.
gemcitabine	—	200mg, 1g, 2g	pwd for IV infusion after reconstitution	1250mg/m² on Days 1 and 8 of each 21-day cycle; give with paclitaxel 175mg/m² administered on Day 1 before gemcitabine.
metho– trexate	—	25mg/mL	soln for IV, IM, intra-arterial, or intrathecal admin after dilution	See drug monograph and manufacturer’s full labeling.
	—	1g	pwd for IV, IM, intra-arterial, or intrathecal admin after dilution
	Trexall	5mg, 7.5mg, 10mg, 15mg	scored tabs
ANTIMICROTUBULE AGENTS
docetaxel	Taxotere	20mg/mL	soln for IV infusion after dilution	Infuse over 1hr once every 3wks. Chemotherapy failure: 60–100mg/m². Adjuvant in operable node (+): 75mg/m²; treat for 6 courses.
eribulin mesylate	Halaven	0.5mg/mL	soln for IV inj	1.4mg/m² IV inj over 2−5min on Days 1 and 8 of each 21‑day cycle.
ixabepilone	Ixempra	15mg, 45mg	pwd for IV infusion after constitution and dilution	Infuse over 3hrs. 40mg/m² once every 3wks. Use max BSA of 2.2m² to calculate dose if BSA >2.2m².
paclitaxel	—	6mg/mL	soln for IV infusion after dilution	Infuse over 3hrs. Node-positive: 175mg/m² IV every 3wks for 4 courses given sequentially to doxorubicin-containing combination chemotherapy. After failure of initial chemotherapy for metastatic disease or relapse: 175mg/m² IV every 3wks.
paclitaxel	Abraxane	100mg	pwd for IV infusion after reconstitution	260mg/m² every 3wks.
vinblastine	—	10mg	lyophilized pwd for IV inj or infusion after reconstitution	5.5−7.4mg/m² once weekly (see full labeling).
vinblastine	—	1mg/mL	soln for IV inj or infusion	5.5−7.4mg/m² once weekly (see full labeling).
AROMATASE INHIBITOR
anastrozole	Arimidex	1mg	tabs	1mg once daily.
exemestane	Aromasin	25mg	tabs	25mg once daily.
letrozole	Femara	2.5mg	tabs	2.5mg once daily.
ESTROGEN
conjugated estrogens	Premarin	0.3mg, 0.45mg, 0.625mg, 0.9mg, 1.25mg	tabs	10mg 3 times daily for at least 3mos.
estradiol	Estrace	0.5mg, 1mg, 2mg	scored tabs	10mg 3 times daily for at least 3mos.
ESTROGEN RECEPTOR ANTAGONIST
elacestrant	Orserdu	86mg, 345mg	tabs	ER-positive, HER2-negative, ESR1-mutated (postmenopausal women, men): 345mg once daily until disease progression or unacceptable toxicity.
fulvestrant	Faslodex	50mg/mL	soln for IM inj	Give by slow IM inj (1–2mins). 500mg (as two 5mL inj, one in each buttock) on Days 1, 15, 29, then once monthly thereafter. Combination therapy: give with palbociclib 125mg daily with food for 21 days, followed by 7 days off, or with abemaciclib 150mg twice daily, or with ribociclib 600mg daily for 21 days followed by 7 days off; in pre/perimenopausal women: also treat with LHRH agonists.
GnRH ANALOGUE
goserelin	Zoladex	3.6mg	SC implant	One 3.6mg implant every 28 days.
HER2-TARGETED ANTIBODY-DRUG CONJUGATE
ado-trastuzumab emtansine	Kadcyla	100mg, 160mg	lyophilized pwd for IV infusion after reconstitution and dilution	Infuse over 90mins. 3.6mg/kg max every 3wks (21-day cycle). MBC: treat until disease progression or unacceptable toxicity. EBC: treat for a total of 14 cycles unless disease recurrence or unacceptable toxicity.
fam-trastuzumab deruxtecan-nxki	Enhertu	100mg	lyophilized pwd for IV infusion after reconstitution and dilution	5.4mg/kg IV over 90mins every 3wks (21-day cycle) until disease progression or unacceptable toxicity.
HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR (HER2) INHIBITOR
margetuximab-cmkb	Margenza	250mg	soln for IV infusion after dilution	15mg/kg every 3wks until disease progression or unacceptable toxicity. Administer immediately after chemotherapy on days when both are administered.
pertuzumab	Perjeta	420mg/ 14mL (30mg/ mL)	soln for IV infusion	Initially 840mg IV over 60mins, followed every 3wks thereafter by a dose of 420mg IV over 30–60mins, in combination with trastuzumab. MBC: also give with docetaxel. Neoadjuvant: give every 3wks for 3–6 cycles as part of one of the treatment regimens for EBC (see full labeling). Adjuvant: give every 3wks for 1yr (up to 18 cycles) or until disease recurrence or unacceptable toxicity, whichever occurs first, as part of EBC regimen (see full labeling).
trastuzumab	Herceptin	440mg	lyophilized pwd for IV infusion after reconstitution and dilution	Metastatic treatment (alone or with paclitaxel): initially 4mg/kg over 90mins, followed by 2mg/kg over 30mins once weekly until disease progression. Adjuvant treatment (give total of 52wks of trastuzumab) in combination therapy: initially 4mg/kg over 90mins, followed by 2mg/kg over 30mins once weekly for the 1st 12wks (concurrently w. paclitaxel or docetaxel) or 18wks (concurrently w. docetaxel/ carboplatin). One week after the last trastuzumab weekly dose, give trastuzumab 6mg/kg over 30–90mins every 3wks. Single agent (within 3wks) following multi-modality anthracycline based therapy: initially 8mg/kg over 90mins, then 6mg/kg over 30–90mins every 3wks.
trastuzumab-anns	Kanjinti	420mg
trastuzumab-dkst	Ogivri	150mg, 420mg
trastuzumab-dttb	Ontruzant	150mg, 420mg
trastuzumab-pkrb	Herzuma	150mg, 420mg
trastuzumab-qyyp	Trazimera	420mg
HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR (HER2) INHIBITOR + ENDOGLYCOSIDASE
pertuzumab + trastuzumab + hyaluronidase-zzxf	Phesgo	1200mg/ 600mg/ 30000 Units per 15mL; 600mg/ 600mg/ 20000 Units per 10mL	soln for SC inj	Initially 1200mg/600mg/30000 Units over ~8mins, followed by 600mg/600mg/20000 Units over ~5mins every 3wks. Switching from IV pertuzumab/trastuzumab (if <6wks since last dose): give 600mg/600mg/20000 Units as a maintenance dose and every 3wks subsequently. Neoadjuvant: give every 3wks for 3–6 cycles as part of a treatment regimen. Following surgery, complete 1 year of treatment (up to 18 cycles) or until disease recurrence or unmanageable toxicity. Adjuvant: give every 3wks for a total of 1 year (up to 18 cycles) or until disease recurrence or unmanageable toxicity. Start on Day 1 of the first taxane-containing cycle (if standard anthracycline- and/or taxane-based chemotherapy is part of regimen). MBC: give initially with docetaxel 75mg/m² IV, may increase to 100mg/m² every 3wks if initial dose is well tolerated. Continue until disease progression or unmanageable toxicity.
trastuzumab + hyaluronidase-oysk	Herceptin Hylecta	600mg/5mL + 10,000units/5mL	soln for SC inj	600mg/10,000 Units SC over 2–5mins once every 3wks. Adjuvant treatment: treat for 52wks or until disease recurrence, whichever occurs first; extending treatment beyond 1yr: not recommended. Metastatic treatment: treat until disease progression.
KINASE INHIBITOR
abemaciclib	Verzenio	50mg, 100mg, 150mg, 200mg	tabs	In combination with fulvestrant, tamoxifen, or an aromatase inhibitor: 150mg twice daily (see full labeling); in pre/perimenopausal women and men (in combination with aromatase inhibitor) or in pre/perimenopausal women (in combination with fulvestrant): also treat with a gonadotropin-releasing hormone agonist according to current practice standards. Monotherapy: 200mg twice daily. Early breast cancer: continue until completion of 2yrs of treatment or until disease recurrence, or unacceptable toxicity. Advanced or metastatic breast cancer: continue until disease progression or unacceptable toxicity.
lapatinib	Tykerb	250mg	tabs	HER2-positive (metastatic): 1250mg once daily on Days 1–21 continuously in combination with capecitabine 2000mg/m²/day on Days 1–14 in a repeating 21 day cycle; continue until disease progression or unacceptable toxicity. HR-positive, HER2-positive (metastatic): 1500mg once daily continuously in combination with letrozole 2.5mg once daily.
neratinib	Nerlynx	40mg	tabs	Early stage: 240mg once daily until disease recurrence or for up to 1yr. Advanced or metastatic: 240mg once daily on Days 1–21 of a 21-day cycle with capecitabine (750mg/m² twice daily) on Days 1–14 of a 21-day cycle until disease progression or unacceptable toxicity. Alternative dose escalation (early stage and advanced/metastatic): 120mg once daily on Days 1–7, then 160mg once daily on Days 8–14, then 240mg once daily thereafter.
palbociclib	Ibrance	75mg, 100mg, 125mg	caps, tabs	Take caps (with food); tabs (with or without food). 125mg once daily for 21 days followed by 7 days off to complete a 28-day cycle, in combination with an aromatase inhibitor or with fulvestrant 500mg on Days 1, 15, 29, and once monthly thereafter. In the combination with fulvestrant therapy: pre/perimenopausal women should be treated with LHRH agonists. In the combination with aromatase inhibitor therapy for men: consider LHRH agonist.
ribociclib	Kisqali	200mg	tabs	600mg once daily for 21 days followed by 7 days off to complete 28-day cycle. In combination with an aromatase inhibitor: see drug’s full labeling. In combination with fulvestrant: give fulvestrant 500mg on Days 1, 15, 29, then once monthly thereafter. Pre/perimenopausal women on combination therapy: also treat with LHRH agonist.
ribociclib + letrozole	Kisqali Femara Co-Pack	200mg + 2.5mg	tabs	Kisqali: 600mg once daily for 21 days, followed by 7 days off to complete 28-day cycle. Femara: 2.5mg once daily throughout the 28-day cycle. Pre/perimenopausal women: also treat with LHRH agonist.
tucatinib	Tukysa	50mg, 150mg	tabs	HER2-positive (advanced unresectable or metastatic): 300mg twice daily (approx. 12hrs apart) until disease progression or unacceptable toxicity. Use in combination with trastuzumab and capecitabine (see respective product labeling for dosing and duration).
mTOR KINASE INHIBITOR
everolimus	Afinitor	2.5mg, 5mg, 7.5mg, 10mg	tabs	10mg once daily until disease progression or unacceptable toxicity.
PD-1/PD-L1 BLOCKING ANTIBODIES
pembrolizumab	Keytruda	25mg/mL	soln for IV infusion after dilution	Early-stage TNBC: 200mg every 3wks for 8 doses or 400mg every 6wks for 4 doses as neoadjuvant treatment for 24wks or until disease progression or unacceptable toxicity, then 200mg every 3wks for 9 doses or 400mg every 6wks for 5 doses as adjuvant treatment (single agent) for up to 27wks or until disease recurrence or unacceptable toxicity; see full labeling. Recurrent unresectable or metastatic TNBC: 200mg every 3wks or 400mg every 6wks until disease progression, unacceptable toxicity, or up to 24mos. In combination with chemotherapy: give prior to chemotherapy when given on the same day.
PHOSPHATIDYLINOSITOL-3-KINASE (PI3K) INHIBITOR
alpelisib	Piqray	50mg, 150mg, 200mg	tabs	300mg once daily with food (in combination with fulvestrant 500mg on Days 1, 15, and 29, then once monthly thereafter) until disease progression or unacceptable toxicity.
POLY (ADP-RIBOSE) POLYMERASE INHIBITOR
olaparib	Lynparza	100mg, 150mg	tabs	300mg twice daily. Early breast cancer: continue for a total of 1yr, or until disease recurrence or unacceptable toxicity. Metastatic: continue until disease progression or unacceptable toxicity.
talazoparib	Talzenna	0.1mg, 0.25mg, 0.5mg, 0.75mg, 1mg	caps	1mg once daily until disease progression or unacceptable toxicity.
PROGESTIN
megestrol acetate	—	20mg, 40mg	scored tabs	40mg 4 times daily.
SELECTIVE ESTROGEN RECEPTOR MODULATOR (SERM)
raloxifene	Evista	60mg	tabs	60mg once daily.
TROP-2 DIRECTED ANTIBODY + TOPOISOMERASE INHIBITOR CONJUGATE
sacituzumab govitecan-hziy	Trodelvy	180mg	lyophilized pwd for IV infusion after reconstitution and dilution	HR-positive, HER2-negative (advanced unresectable or metastatic), mTNBC: 10mg/kg (max dose) once weekly on Days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity. Infuse 1st infusion over 3hrs, then over 1–2hrs for subsequent infusions if tolerated.
NOTES
Key: DCIS = ductal carcinoma in situ; EBC = early breast cancer; MBC = metastatic breast cancer; mTNBC = metastatic triple-negative breast cancer Not an inclusive list of medications and/or doses. Please see drug monograph at www.eMPR.com and/or contact company for full drug labeling. (Rev. 9/2023)

Want to read more?