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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00234403
First received: October 5, 2005
Last updated: April 22, 2009
Last verified: April 2009
  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 2

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

Resource links provided by NLM:


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: October 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Spain
Investigative Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Spain Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00234403     History of Changes
Other Study ID Numbers: 1839IL/0141
Study First Received: October 5, 2005
Last Updated: April 22, 2009
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Fulvestrant
Gefitinib
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014