A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer

AstraZeneca1 site in 1 country60 target enrollmentMay 2004

ConditionsBreast Cancer

Drugsgefitinib and fulvestrant

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: AstraZeneca
Enrollment: 60
Locations: 1
Primary Endpoint: To evaluate the progression-free survival (PFS) of the combination of 250 mg ZD1839 and fulvestrant in patients with advanced or metastatic breast cancer
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

October 2007

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

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

•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

Outcomes

Primary Outcomes

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 Outcomes

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