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

April 22, 2009 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Breast Cancer

Intervention / Treatment

Drug: gefitinib and fulvestrant

Study Type

Interventional

Enrollment

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Spain
- - 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
    - Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

October 5, 2005

First Submitted That Met QC Criteria

October 5, 2005

First Posted (ESTIMATE)

October 7, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 23, 2009

Last Update Submitted That Met QC Criteria

April 22, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

1839IL/0141

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.