FASLODEXTM is indicated as monotherapy for the treatment of oestrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women:
- Not previously treated with endocrine therapy, or
- With disease relapse on or after adjuvant antioestrogen therapy, or disease progression on antioestrogen therapy
Faslodex is also indicated in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.
- In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinising hormone releasing hormone agonist.
COMBINATION WITH PALBOCICLIB
PALOMA-3 STUDY DESIGN
FASLODEX 500 mg was studied in combination with palbociclib 125 mg vs FASLODEX plus placebo (the control arm).* PALOMA-3, a phase 3, international,
The primary endpoint was investigator-assessed PFS, evaluated according to RECIST v.1.1.3,4
Adapted from Cristofanilli, M et al. Lancet Oncol. 2016;17(4):425-439.3
- All patients received prior systemic therapy3,4
- 75% of patients received a previous chemotherapy regimen, 34% of which was in the metastatic setting3
- Patients were permitted to have 1 prior line of chemotherapy for advanced disease and/or multiple lines of prior endocrine therapy3
ABC=advanced breast cancer; AI=aromatase inhibitor; ER=oestrogen receptor; HER2=human epidermal growth factor receptor 2; HR=hormone receptor; mBC=metastatic breast cancer; PFS=progression-free survival; RECIST=Response Evaluation Criteria in Solid Tumors.
*Patients in both arms received FASLODEX 500 mg by intramuscular injection on Days 1, 15, and 29 of the first month, and every 28 (± 3) days thereafter, and either oral palbociclib 125 mg or placebo for 21 consecutive days followed by 7 days off treatment.3
† Women who were either premenopausal or perimenopausal were therapeutically induced to become postmenopausal and represented 20.7% of the study population.3,4
‡Disease relapse or progression had to occur during or within 1 month after treatment in the advanced setting, or during or within 12 months of completion of adjuvant therapy.
§All pre/perimenopausal women had to have commenced treatment with