FASLODEXTM
(fulvestrant)

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.

FASLODEX MONOTHERAPY AFTER PRIOR ENDOCRINE THERAPY

CONFIRM STUDY PATIENT POPULATION

Patients had HER2 - locally advanced or metastatic ER+ and/or PgR + disease

The median number of disease sites was 2, with levels of metastatic disease from bone-only to visceral involvement2     

  • 64% of patients had visceral involvement2

mBC=metastatic breast cancer.

Time of relapse/progression
FASLODEX 500 mg (n=362)
  FASLODEX 250 mg (n=374)
 
  N
%
N %
During adjuvant therapy
175
48.3
169
45.2
Early relapse
16
4.4
27
7.2
Late relapse
36
9.9
52
13.9
De novo
130
35.9
125
33.4
Other
5
1.4
1
0.3

Early relapse = 0-12 months after completion of adjuvant endocrine therapy
Late relapse = >12 months after completion of adjuvant endocrine therapy and after progression on first-line endocrine therapy for advanced disease
De novo = Patients presenting with de novo advanced disease and experiencing progression on first-line endocrine therapy

The majority of patients were responsive to their last hormonal therapy before randomisation2
65% responsive|| to last hormonal therapy before randomisation
35% not responsive to last hormonal therapy before randomisation or response unknown
The majority were under 65 years of age, with a median of 61 years2

||Patients were categorised as "responsive" if they had recurrence after 2 or more years on their last previous adjuvant endocrine therapy, and/or if they experienced complete response, partial response, or stable disease for greater than 24 weeks on first-line endocrine therapy for ABC.2
Patients were categorised as not responsive if they had recurrence within the first 2 years on their last previous adjuvant endocrine therapy, and if they experienced stable disease for less than 24 weeks or progressive disease on first-line endocrine therapy for ABC.2