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A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer

Inclusion Criteria:

- Histologically confirmed advanced or metastatic breast cancer

- postmenopausal females with amenorrhoea > 12 months and an intact uterus

- FSH levels within postmenopausal range or have undergone a bilateral oophorectomy

- ER &/or PR positive

- previous adjuvant hormone therapy > 12 months prior to enrolment

- previous adjuvant chemotherapy > 6 months prior to enrolment

- measurable disease according to RECIST and/or non measurable bone disease

- life expectancy of at least 12 weeks

- World Health Organisation (WHO) performance status (PS) of 0 to 1.

Exclusion Criteria:

- Male

- life-threatening metastatic visceral disease

- evidence of clinically active interstitial lung disease

- ER and PR negative

- treatment with LHRH analogues < 3 months prior to enrolment

- patients who have restarted menses or do not have FSH levels within the
postmenopausal range

- treatment with strontium - 90 (or other radio pharmaceutical) within the previous 3

- Treatment with hormonotherapy and/or chemotherapy for advanced disease

- extensive radiotherapy to measurable lesions within the last 4 weeks (i.e. >30% of
bone marrow, e.g. whole of pelvis or half of spine)

- currently receiving oestrogen replacement therapy

- treatment with a non-approved or experimental drug within 4 weeks before enrolment

- absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than
100 x 109/L , serum bilirubin greater than 1.25 times the upper limit of reference
range (ULRR, serum creatinine greater than 1.5 mg/dL, alanine aminotransferase (ALT)
or aspartate aminotransferase (AST) greater than 2.5 times the ULRR if no
demonstrable liver metastases, or greater than 5 times the ULRR in the presence of
liver metastases, history of bleeding diathesis or long term or present anticoagulant
therapy (other than antiplatelet therapy

- any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer

- concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known

- severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer

Principal Investigator

AstraZeneca Spain Medical Director, MD

Investigator Role:

Study Director

Investigator Affiliation:



Spain: Spanish Agency of Medicines

Study ID:




Start Date:

May 2004

Completion Date:

October 2007

Related Keywords:

  • Breast Cancer
  • Advanced breast cancer
  • Metastatic breast cancer
  • ER positive breast cancer
  • PR positive breast cancer
  • Breast Neoplasms