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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2007-10-31

Brief Summary

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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

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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gefitinib and fulvestrant

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No