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.

Monotherapy in endocrine therapy naïve patients

FALCON STUDY PATIENT POPULATION

FASLODEX was studied in an endocrine therapy-naïve patient population.1 At baseline, 84% of patients had measurable disease and 87% had metastatic disease.1

Patients with visceral metastases and patients with non-visceral metastases were represented in the FALCON Trial1,4

 

 

55% visceral involvement§

45% non-visceral involvement

 

 

§Includes patients with site of baseline disease as any of the following: adrenal, bladder, central nervous system, oesophagus, liver, lung, peritoneum, pleura, renal, small bowel, stomach, pancreas, thyroid, colon, rectum, ovary, biliary tract, ascites, pericardial effusion, spleen, or pleural effusion.1

Approximately 96% of patients had a WHO¶ performance status of 0 or 11

WHO Status Average percentage (%) of patients across both treatment arms
0 50.2%
1 45.7%
2 4.1%

For WHO performance status, 0 represents normal activity, 1 represents restricted activity, and 2 represents being in bed 50% of the time or less.1

Approximately 57% of patients were under 65 years of age1

Median age 63 years at study entry (range: 36 to 90 years)
Median age 63 years at study entry (range: 36 to 90 years)

Prior treatment in the FALCON Trial, with timing ranging from the neoadjuvant to metastatic setting1

Type of therapy
Average percentage (%) of patients across both treatment arms
Chemotherapy
 
                  ABC (1 line)
17.1%
                  Adjuvant
13.4%
                  Neoadjuvant
5.8%
Radiotherapy
22.3%
Hormonal therapy||
0.6%

ABC=advanced breast cancer.
||Represents a protocol deviation in the FALCON Trial. Three patients were found to have received prior hormonal therapy after randomisation occurred.1

Metastatic sites in the FALCON Trial1

Median age 63 years at study entry (range: 36 to 90 years)
Median age 63 years at study entry (range: 36 to 90 years)

 

Patients in the FALCON Trial were permitted to have more than 1 site of metastasis.4