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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00234403
First received: October 5, 2005
Last updated: April 22, 2009
Last verified: April 2009

October 5, 2005
April 22, 2009
May 2004
Not Provided
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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
Drug: gefitinib and fulvestrant
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2007
Not Provided

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00234403
1839IL/0141
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca
AstraZeneca
April 2009

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