Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
This study is currently recruiting patients.
Sponsored by: |
European Organization for Research and Treatment of Cancer
|
Information provided by: |
National Cancer Institute (NCI) |
Purpose
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
|
Treatment or Intervention |
Phase |
recurrent breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer
|
Drug: anastrozole Drug: gefitinib Procedure: aromatase inhibition Procedure: endocrine therapy Procedure: enzyme inhibitor therapy Procedure: hormone therapy Procedure: protein tyrosine kinase inhibitor therapy
|
Phase II
|
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Randomized Study of Anastrozole With or Without Gefitinib in Postmenopausal Women With Metastatic or Locally Recurrent
Breast Cancer
Further Study Details:
OBJECTIVES:
- Compare the antitumor activity of anastrozole with vs without gefitinib, in terms of clinical benefit rate, 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), and stage (metastatic vs
locally recurrent). 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.
Eligibility
Genders Eligible for Study:
Both
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Radiologically or clinically evident metastatic or locally recurrent disease
- Unidimensionally measurable disease
- Failed prior tamoxifen therapy
- No rapidly progressive visceral metastases
- No uncontrolled CNS metastases
- Hormone receptor status:
- Estrogen receptor and/or progesterone receptor positive
PATIENT CHARACTERISTICS: Age
Sex
Menopausal status
- 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
Life expectancy
Hematopoietic
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
- 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)
- 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
- 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
Location
and Contact
Information
Netherlands Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital, Amsterdam,
1066 CX,
Netherlands; Recruiting
Contact Person
31-2512-2552
Study chairs or principal investigators
Emiel J. Rutgers, MD, PhD, FRCS, Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Martine J. Piccart-Gebhart, MD, Institut Jules Bordet
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers:
CDR0000315629; EORTC-10021; IDBBC-10021
Record last reviewed:
November 2003
Record first received:
August 6, 2003
ClinicalTrials.gov Identifier:
NCT00066378Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2004-11-05