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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:

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: gefitinib and fulvestrant Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer
Study Start Date : May 2004
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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

Secondary Outcome Measures :
  1. To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure.
  2. To estimate the disease control rate at trial closure.
  3. To estimate overall survival.
  4. To evaluate the safety & tolerability of the combination gefitinib and fulvestrant

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00234403

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Investigative Site
Alicante, Spain
Investigative Site
Gerona, Spain
Investigative Site
Jaen, Spain
Investigative Site
Madrid, Spain
Investigative Site
Seville, Spain
Investigative Site
Valencia, Spain
Investigative Site
Zaragoza, Spain
Sponsors and Collaborators
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Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca

Layout table for additonal information Identifier: NCT00234403     History of Changes
Other Study ID Numbers: 1839IL/0141
First Posted: October 7, 2005    Key Record Dates
Last Update Posted: April 23, 2009
Last Verified: April 2009
Keywords provided by AstraZeneca:
Advanced breast cancer
Metastatic breast cancer
ER positive breast cancer
PR positive breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs