This is the fourth in a series about FDA-approved treatments for each sub-type of MBC. Later this week I'll post about approved treatments for TNBC.
The treatment options listed below have been reviewed with a Medical Oncologist at Columbia Presbyterian Hospital in NY. Detailed information about them is available in my book, "The Insider's Guide to Metastatic Breast Cancer" which is available as a paperback and eBook, and also a complimentary .pdf. For more information please visit: insidersguidembc.com/about
NCCN 2019 Guidelines state that hormonal (endocrine) therapy without HER2-targeted therapy may be considered in specific circumstances: if the patient’s cancer is only in the bones (or if it’s in an organ and there are no symptoms), it appears that the patient is likely to respond to endocrine therapy due to a long disease-free interval, there are limited sites of disease, a slow disease progression (“indolent disease”), and the patient is older in age.
Hormonal therapy options for eligible triple positive patients in the US are listed immediately below with the understanding that premenopausal women - as well as men - should also take a Luteinizing Hormone-Releasing Hormone (LHRH) agonist such as Zoladex (Goserelin), Lupron (Leuprolide) or Trelstar (Triptorelin) to suppress the production of specific hormones in the body (this is optional when taking Tamoxifen or Fareston). If the cancer progresses on initial endocrine therapy, another type of endocrine therapy may be considered, or a HER2-targeted therapy (with or without hormonal therapy) may be taken.
•An Aromatase Inhibitor (AI) such as Letrozole (Femara), Arimidex (Anastrozole), or Aromasin (Exemestane).
•Faslodex (Fulvestrant) with or without Arimidex.
•Tamoxifen (Nolvadex) or Fareston (Toremifene).
HER2-TARGETED THERAPY FOR TRIPLE POSITIVE PATIENTS IN THE US MAY BE TAKEN ALONE, OR IN COMBINATION WITH EITHER CHEMOTHERAPY OR HORMONAL THERAPY AS DESCRIBED BELOW. A CLINICAL TRIAL IS ALSO AN OPTION.
HER2 Targeted Therapy Options for Triple Positive Patients in the US with or without Chemotherapy:
•Herceptin (Trastuzumab) (or a biosimilar), or Herceptin Hylecta (the subcutaneous injectable form of Herceptin) with Perjeta (Pertuzumab) and a Taxane chemotherapy. (According to NCCN 2019 Guidelines, this “triplet” is the preferred therapy for triple positive patients. Once chemotherapy is stopped, hormonal therapy may be added to Herceptin and Perjeta).
•Herceptin (or a biosimilar) with chemotherapy.
•Herceptin (or a biosimilar) with Tykerb (Lapatinib).
•Tykerb with chemotherapy.
Additional lines of HER2-Targeted Therapy for Triple Positive US patients include:
•Herceptin (or a biosimilar) and Perjeta, with or without chemotherapy (if the patient has previously taken Herceptin and chemotherapy without Perjeta).
•Kadcyla (TDM-1/Ado-trastuzumab emtansine) alone.
•Herceptin Hylecta alone (if the patient has received one or more chemotherapy courses for MBC).
HER2-Targeted Therapy Options Combined with Hormonal Therapy for Triple Positive Patients in the US:
As mentioned above, premenopausal women - as well as men - should take a Luteinizing Hormone-Releasing Hormone agonist while taking hormonal therapy, although this is optional when taking Tamoxifen or Fareston.
•An Aromatase Inhibitor with Herceptin (or a biosimilar).
•An Aromatase Inhibitor with Tykerb, with or without Herceptin.
•Faslodex with Herceptin (or a biosimilar).
•Tamoxifen or Fareston with Herceptin (or a biosimilar).
•Herceptin (or a biosimilar) with Perjeta (Pertuzumab) and any one of the above hormonal therapies.
DID YOU KNOW?
Patients with bone metastases should receive a bone-directed therapy such as Xgeva (Denosumab) or Zometa (Zoledronic acid) in addition to their other therapy.
If a US patient’s cancer has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) characteristics (which are very rare), and if the patient has progressed on prior therapy and has no satisfactory treatment options, Keytruda (a PD-1 inhibitor also known as Pembrolizumab), is an FDA-approved option.
If a US patient’s cancer has a Neurotrophic Receptor Tyrosine Kinase (NTRK) gene fusion without a known acquired resistance mutation, and if there has been progression on prior therapy with no satisfactory treatment options, Larotrectinib (Vitrakvi) - an oral tyrosine kinase inhibitor that acts as an "on" or "off" switch in many cellular functions – is an FDA-approved option. NTRK fusions are extremely rare, occurring in only about 0.5–1% of common cancers.