Breast CancerPhase 2NCT00066378
Anastrozole With or Without Gefitinib in Treating Postmenopausal Women With Metastatic or Locally Recurrent Breast Cancer
A Phase 2 study testing anastrozole and gefitinib in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 9 sites in 5 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- anastrozole and gefitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 9 sitesin 5 countries
- Study dates
- May 2003to Aug 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- 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
- Hormone receptor status:
- Estrogen receptor and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
- Postmenopausal
Sex
- Female
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
- 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
- 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
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Belgium3 sites
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, B-2020
Institut Jules Bordet
Brussels, 1000
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, 2610
France2 sites
Institut Bergonie
Bordeaux, 33076
Centre Henri Becquerel
Rouen, 76038
Netherlands2 sites
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, 1066 CX
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, NL-6500 HB
United Kingdom1 site
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, EH4 2XU
About this study
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
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- anastrozole, gefitinib
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anastrozoleDrug
gefitinibDrug
| Study group | Role | What they receive |
|---|---|---|
| Arimidex + Iressa® 250 mg | Experimental | Arimidex + Iressa® 250 mg Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal Receives: Drug: anastrozole; Drug: gefitinib |
| Arimidex + Placebo | Active comparator | Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal Receives: Drug: anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival at 1 year
Measured: at 1 year
Secondary outcomes (3)
Tumor response as measured by RECIST
Measured: from randomisation
Duration of response as measured by RECIST
Measured: response duration
Safety as measured by CTC v2.0
Measured: from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2003 (estimated)
- Study startMay 2003
- Primary completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine J. Piccart, MD, PhD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066378
- Sponsor's protocol ID
- EORTC-10021
- Other IDs
- EORTC-10021, IDBBC-10021
- Status last verified
- Oct 2013
- First submitted
- 6 Aug 2003
- Last updated
- 24 Oct 2013
- Results posted
- No
Publications
Mauriac L, Cameron D, Dirix L: Results of randomized phase II trial combining Iressa (gefitinib) and arimidex in women with advanced breast cancer (ABC): EORTC protocol 10021. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-6133, 2008.
Tryfonidis K, Basaran G, Bogaerts J, Debled M, Dirix L, Thery JC, Tjan-Heijnen VC, Van den Weyngaert D, Cufer T, Piccart M, Cameron D; EORTC-Breast Cancer Group. A European Organisation for Research and Treatment of Cancer randomized, double-blind, placebo-controlled, multicentre phase II trial of anastrozole in combination with gefitinib or placebo in hormone receptor-positive advanced breast cancer (NCT00066378). Eur J Cancer. 2016 Jan;53:144-54. doi: 10.1016/j.ejca.2015.10.012. Epub 2015 Dec 24.
PubMed 26724641
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00066378
- Acronym / sponsor ID
- EORTC-10021
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- May 2003
- Primary completion
- Aug 2007 (actual)
- First posted
- 7 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arimidex + Iressa® 250 mg | Experimental | Drug: anastrozole, Drug: gefitinibArimidex + Iressa® 250 mg Treatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal |
| Arimidex + Placebo | Active comparator | Drug: anastrozoleTreatment should be administered until documented disease progression, unacceptable toxicity as judged by the responsible physician or patient refusal |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anastrozole | Drug | Arimidex + Iressa® 250 mg, Arimidex + Placebo |
| gefitinib | Drug | Arimidex + Iressa® 250 mg |
Primary outcome
Progression-free survival at 1 year
Time frame: at 1 year
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2013.
- Results publicationMauriac L, Cameron D, Dirix L: Results of randomized phase II trial combining Iressa (gefitinib) and arimidex in women with advanced breast cancer (ABC): EORTC protocol 10021. [Abstract] 31st Annual San Antonio Breast Cancer Symposium, December 10-14, 2008, San Antonio, Texas. A-6133, 2008.
- Derived from this study: PubMed 26724641Tryfonidis K, Basaran G, Bogaerts J, Debled M, Dirix L, Thery JC, Tjan-Heijnen VC, Van den Weyngaert D, Cufer T, Piccart M, Cameron D; EORTC-Breast Cancer Group. A European Organisation for Research and Treatment of Cancer randomized, double-blind, placebo-controlled, multicentre phase II trial of anastrozole in combination with gefitinib or placebo in hormone receptor-positive advanced breast cancer (NCT00066378). Eur J Cancer. 2016 Jan;53:144-54. doi: 10.1016/j.ejca.2015.10.012. Epub 2015 Dec 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martine J. Piccart, MD, PhD study chair
Jules Bordet Institute
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anastrozole and gefitinib in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belgium, France, Netherlands, Slovenia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival at 1 year (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066378, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2013.