Clinical trial NCT00234403: A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Advanced breast cancer
Metastatic breast cancer
ER positive breast cancer
PR positive breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-10-07
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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:

* 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.

Primary outcomes:
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 outcomes:
measure: To estimate the objective response rate (complete response [CR] and partial response [PR]) at trial closure.
measure: To estimate the disease control rate at trial closure.
measure: To estimate overall survival.
measure: To evaluate the safety & tolerability of the combination gefitinib and fulvestrant
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Investigative Site
city: Gerona
country: Spain
facility: Investigative Site
city: Jaen
country: Spain
facility: Investigative Site
city: Madrid
country: Spain
facility: Investigative Site
city: Seville
country: Spain
facility: Investigative Site
city: Valencia
country: Spain
facility: Investigative Site
city: Zaragoza
country: Spain
facility: Investigative Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Spain Medical Director, MD
role: STUDY_DIRECTOR
References: