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

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00234403

Purpose

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	Intervention	Phase
Breast Cancer	Drug: gefitinib and fulvestrant	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: ZD1839 Ici 182780

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Trial to Evaluate the Combination of ZD1839 (Iressa) and Fulvestrant (Faslodex®) in Patients With Advanced or Metastatic Breast Cancer

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	60
Study Start Date:	May 2004
Study Completion Date:	June 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00234403

Locations

Spain
Investigative Site
Gerona, Spain
Investigative Site
Alicante, Spain
Investigative Site
Valencia, Spain
Investigative Site
Zaragoza, Spain
Investigative Site
Madrid, Spain
Investigative Site
Seville, Spain
Investigative Site
Jaen, Spain

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Spain Medical Director, MD

AstraZeneca

More Information

Study ID Numbers:	1839IL/0141
Study First Received:	October 5, 2005
Last Updated:	December 16, 2007
ClinicalTrials.gov Identifier:	NCT00234403
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:

Advanced breast cancer
Metastatic breast cancer
ER positive breast cancer
PR positive breast cancer

Study placed in the following topic categories:

Skin Diseases
Fulvestrant
Breast Neoplasms
Gefitinib
Breast Diseases

Additional relevant MeSH terms:

Estrogen Receptor Modulators
Estrogen Antagonists
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Hormone Antagonists
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009