A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00234403
Recruitment Status : Completed
First Posted : October 7, 2005
Last Update Posted : April 23, 2009
Information provided by:

October 5, 2005
October 7, 2005
April 23, 2009
May 2004
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To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer
Same as current
Complete list of historical versions of study NCT00234403 on Archive Site
  • To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure.
  • To estimate the disease control rate at trial closure.
  • To estimate overall survival.
  • To evaluate the safety & tolerability of the combination gefitinib and fulvestrant
Same as current
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A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer
A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer
The progression free survival and efficacy of 250 mg ZD1839 in combination with a fixed dose of fulvestrant 250 mg im once a month will be evaluated in female patients with histologically-confirmed advanced or metastatic, ER and/or PR positive breast cancer
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
Drug: gefitinib and fulvestrant
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2007
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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 months
  • 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 therapy
  • concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, known
  • severe hypersensitivity to ZD1839 or fulvestrant or any of the excipients of this product.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP