A Trial to Evaluate the Combination of Iressa & Faslodex® in Patients With Advanced or Metastatic Breast Cancer
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00234403
First received: October 5, 2005
Last updated: April 22, 2009
Last verified: April 2009
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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
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 Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013