Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
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| ClinicalTrials.gov Identifier: NCT00066378 |
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Recruitment Status :
Completed
First Posted : August 7, 2003
Last Update Posted : October 24, 2013
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RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by reducing the production of estrogen. Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Combining anastrozole with gefitinib may kill more tumor cells.
PURPOSE: Randomized phase II trial to compare the effectiveness of anastrozole with or without gefitinib in treating postmenopausal women who have metastatic or locally recurrent breast cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Breast Cancer | Drug: anastrozole Drug: gefitinib | Phase 2 |
OBJECTIVES:
- Compare the 1 year antitumor activity of anastrozole with vs without gefitinib, in terms of progression-free survival, in postmenopausal women with metastatic or locally recurrent advanced breast cancer.
- Compare the objective tumor response and duration of tumor response in patients treated with these regimens.
- Compare the progression-free survival of patients treated with these regimens.
- Compare the safety of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center, dominant site of metastatic disease (bone alone vs other), prior chemotherapy (no vs yes), stage (metastatic vs locally recurrent), and measurability (measurable vs evaluable). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral anastrozole and oral gefitinib once daily.
- Arm II: Patients receive oral anastrozole and an oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 108 patients (54 per treatment arm) will be accrued for this study.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 71 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | An EORTC Randomized, Double Blind, Placebo-Controlled, Phase II Multi-Center Trial Of Anastrozole (Arimidex) In Combination With ZD 1839 (Iressa) Or Placebo In Patients With Advanced Breast Cancer |
| Study Start Date : | May 2003 |
| Actual Primary Completion Date : | August 2007 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arimidex + Iressa® 250 mg
Arimidex + Iressa® 250 mg Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
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Drug: anastrozole Drug: gefitinib |
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Active Comparator: Arimidex + Placebo
Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal
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Drug: anastrozole |
- Progression-free survival at 1 year [ Time Frame: at 1 year ]
- Tumor response as measured by RECIST [ Time Frame: from randomisation ]
- Duration of response as measured by RECIST [ Time Frame: response duration ]
- Safety as measured by CTC v2.0 [ Time Frame: from randomization ]
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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Histologically confirmed breast cancer
- Radiologically or clinically evident metastatic or locally recurrent disease
- Locally advanced disease in elderly patients
- Bone metastases only allowed
- Failed prior tamoxifen therapy
- No rapidly progressive visceral metastases
- No uncontrolled CNS metastases
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Hormone receptor status:
- Estrogen receptor and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
- Postmenopausal
Sex
- Female
Menopausal status
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Postmenopausal, defined by any of the following:
- Natural menopause with last menses more than 1 year ago
- Radiotherapy-induced oophorectomy with last menses more than 1 year ago
- Chemotherapy-induced menopause with last menses more than 1 year ago AND serum follicle-stimulating hormone and luteinizing hormone and plasma estradiol levels clearly in the postmenopausal range
- Surgical castration
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Transaminases no greater than 2.5 times ULN
- No unstable or uncompensated hepatic disease
Renal
- No unstable or uncompensated renal disease
Cardiovascular
- No unstable or uncompensated cardiac disease
Pulmonary
- No unstable or uncompensated pulmonary disease
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No clinically active interstitial lung disease
- Asymptomatic chronic stable radiographic changes are allowed
Other
- No severe or uncontrolled systemic disease
- No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, nonmelanoma skin cancer, or contralateral breast cancer
- No psychological, familial, sociological or geographical condition that would preclude study compliance and follow-up
- No grade 2 or greater unresolved chronic toxicity from prior anticancer therapy
- No unresolved ocular inflammation or infection
- No known hypersensitivity to anastrozole or gefitinib or any of their excipients
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior trastuzumab (Herceptin)
- No concurrent biologic therapy
Chemotherapy
- No more than 1 line of prior chemotherapy in the adjuvant or metastatic setting
- No concurrent chemotherapy
Endocrine therapy
- At least 2 years since prior aromatase inhibitors (e.g., anastrozole, letrozole, or exemestane) in the adjuvant setting
- Prior tamoxifen or fulvestrant in the adjuvant and/or metastatic setting allowed
- No prior aromatase inhibitors for metastatic disease
- No other concurrent hormonal therapy
Radiotherapy
- No concurrent radiotherapy to any metastatic site
Surgery
- No surgery during and within 4 days after the last dose of gefitinib
Other
- At least 30 days since prior investigational drugs
- No prior anti-epidermal growth factor therapy
- No prior anti-vascular endothelial growth factor therapy (i.e., tyrosine kinase inhibitor receptor)
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No concurrent administration of any of the following drugs:
- Phenytoin
- Carbamazepine
- Rifampin
- Phenobarbital
- Hypericum perforatum (St John's Wort)
- No other concurrent investigational drugs or treatment
- No other concurrent cancer treatment
- No concurrent systemic retinoids
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Concurrent bisphosphonate therapy for the treatment and prevention of bony metastases is allowed provided therapy was initiated prior to study entry
- Bisphosphonates may be initiated during study only for the treatment of hypercalcemia
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066378
| Belgium | |
| Ziekenhuis Netwerk Antwerpen Middelheim | |
| Antwerpen, Belgium, B-2020 | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Algemeen Ziekenhuis Sint-Augustinus | |
| Wilrijk, Belgium, 2610 | |
| France | |
| Institut Bergonie | |
| Bordeaux, France, 33076 | |
| Centre Henri Becquerel | |
| Rouen, France, 76038 | |
| Netherlands | |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | |
| Amsterdam, Netherlands, 1066 CX | |
| Universitair Medisch Centrum St. Radboud - Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Slovenia | |
| Institute of Oncology - Ljubljana | |
| Ljubljana, Slovenia, Sl-1000 | |
| United Kingdom | |
| Edinburgh Cancer Centre at Western General Hospital | |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Study Chair: | Martine J. Piccart, MD, PhD | Jules Bordet Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | European Organisation for Research and Treatment of Cancer - EORTC |
| ClinicalTrials.gov Identifier: | NCT00066378 |
| Other Study ID Numbers: |
EORTC-10021 EORTC-10021 IDBBC-10021 |
| First Posted: | August 7, 2003 Key Record Dates |
| Last Update Posted: | October 24, 2013 |
| Last Verified: | October 2013 |
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recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Gefitinib Anastrozole Antineoplastic Agents Protein Kinase Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal Aromatase Inhibitors Steroid Synthesis Inhibitors Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs |