Breast CancerPhase 2NCT00066339
Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy
A Phase 2 study testing gefitinib in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Belgium.
Trial summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- gefitinib
- How many people
- 44 participants
- Where
- 1 siteBelgium
- Study dates
- May 2003to Jan 2004
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Radiological and/or clinical evidence of metastatic disease
- Progressive disease after prior therapy with an antiestrogen (e.g., tamoxifen or faslodex) and a nonsteroidal aromatase inhibitor (e.g., anastrozole or letrozole) in the adjuvant and/or metastatic setting* NOTE: *Endocrine therapy must be the last treatment before study entry
- Unidimensionally measurable disease
- No rapidly progressive visceral metastases
- No uncontrolled CNS metastases
- Hormone receptor status:
- Estrogen receptor and/or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Not specified
Menopausal status
- Postmenopausal, defined as any of the following:
- Natural menopause with at least 1 year since last menses
- Radiation-induced oophorectomy with last menses more than 1 year ago
- Chemotherapy-induced menopause with 1 year since last menses and serum follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels 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 severe or uncontrolled hepatic disease
Renal
- No severe or uncontrolled renal disease
Cardiovascular
- No severe or uncontrolled cardiac disease
Pulmonary
- No severe or uncontrolled respiratory disease
- No evidence of clinically active interstitial lung disease
- Asymptomatic chronic stable radiographic changes allowed
Other
- No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer
- No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up
- No other severe or uncontrolled systemic disease
- No known hypersensitivity to any excipients of gefitinib
- No unresolved chronic toxicity greater than grade 2
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent biologic agents
Chemotherapy
- No more than 1 prior chemotherapy regimen for metastatic breast cancer
- No concurrent chemotherapy
Endocrine therapy
- See Disease Characteristics
- No concurrent hormonal therapy
Radiotherapy
- Prior radiotherapy allowed
- No concurrent radiotherapy to any metastatic site
Surgery
- No surgery within 4 days after study drug administration
Other
- No prior epidermal growth factor receptor inhibitor therapy
- More than 30 days since prior investigational drugs
- No concurrent use of any of the following:
- Phenytoin
- Carbamazepine
- Rifampin
- Phenobarbital
- Hypericum perforatum (St. John's Wort)
- No concurrent systemic retinoids
- No other concurrent investigational drugs or treatments
- No other concurrent anticancer treatments
- Concurrent bisphosphonates for the treatment and prevention of bony metastases are allowed provided therapy was initiated before study enrollment* NOTE: *Bisphosphonates may be initiated during study participation for the treatment of hypercalcemia only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An IDBBC Single Arm Phase II Trial Evaluating The Activity Of Iressa (ZD1839) In Metastatic Breast Cancer Patients Pretreated With An Antiestrogen And A Non-Steroidal Aromatase Inhibitor (Anastrozole Or Letrozole)
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy.
Read the detailed description
OBJECTIVES:
- Determine the clinical benefit rate, defined as complete response, partial response, or stable disease after at least 24 weeks, in patients receiving gefitinib for metastatic breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase inhibitor therapy.
- Determine the best overall response rate of patients treated with this drug.
- Determine the progression-free survival of patients treated with this drug.
- Determine the duration of response in patients treated with this drug.
- Determine the safety of this drug in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients who go off study in the absence of disease progression are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- gefitinib
- Keywords
- stage IV breast cancer, recurrent 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.
gefitinibDrug
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 completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine J. Piccart-Gebhart, MD, PhD, Study chair, Jules Bordet Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066339
- Sponsor's protocol ID
- EORTC-10012
- Other IDs
- EORTC-10012, IDBBC-10012
- Status last verified
- Jul 2012
- First submitted
- 6 Aug 2003
- Last updated
- 18 Jul 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An IDBBC Single Arm Phase II Trial Evaluating The Activity Of Iressa (ZD1839) In Metastatic Breast Cancer Patients Pretreated With An Antiestrogen And A Non-Steroidal Aromatase Inhibitor (Anastrozole Or Letrozole)
- ClinicalTrials.gov ID
- NCT00066339
- Acronym / sponsor ID
- EORTC-10012
- Conditions
- Breast Cancer
- Keywords
- stage IV breast cancer, recurrent breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- European Organisation for Research and Treatment of Cancer - EORTCResearch network
- Study start
- May 2003
- Primary completion
- Jan 2004 (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: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.
PURPOSE: Phase II trial to study the effectiveness of gefitinib in treating patients who have metastatic breast cancer that has not responded to antiestrogen and nonsteroidal aromatase inhibitor therapy.
Detailed description
OBJECTIVES:
- Determine the clinical benefit rate, defined as complete response, partial response, or stable disease after at least 24 weeks, in patients receiving gefitinib for metastatic breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase inhibitor therapy.
- Determine the best overall response rate of patients treated with this drug.
- Determine the progression-free survival of patients treated with this drug.
- Determine the duration of response in patients treated with this drug.
- Determine the safety of this drug in these patients.
OUTLINE: This is a nonrandomized, open-label, multicenter study.
Patients receive oral gefitinib once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients who go off study in the absence of disease progression are followed every 8 weeks until disease progression.
PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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 |
|---|---|---|
| gefitinib | Drug | – |
Primary outcome
Not reported in the source record.
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 18 Jul 2012.
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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-Gebhart, MD, PhD study chair
Jules Bordet Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gefitinib in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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.
Where can I read the original study information?
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 18 Jul 2012.