Breast CancerPhase 2NCT00049062
Anastrozole and ZD 1839 in Treating Postmenopausal Women With Metastatic Breast Cancer
A Phase 2 study testing anastrozole and gefitinib in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- anastrozole and gefitinib
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Sep 2002to Oct 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer
- Metastatic or locally advanced unresectable disease
- At least 1 measurable target lesion that has not been irradiated
- New lesions in a previously irradiated field allowed as sites of measurable disease
- Progressive disease after more than 2 months of aromatase inhibitor therapy
- No known CNS disease or unevaluated CNS symptoms suggestive of brain metastases
- Hormone receptor status:
- Estrogen receptor or progesterone receptor positive
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Female
Menopausal status
- Post-menopausal by 1 of the following criteria:
- Age 50 and over and has not menstruated during the past year or has castrate follicle-stimulating hormone (FSH) levels (greater than 40 IU/L)
- Under age 50 and has castrate FSH levels
- Received prior bilateral oophorectomy and has castrate FSH levels
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- ALT or AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)
Renal
- Creatinine no greater than 1.5 times ULN
Cardiovascular
- No history of congestive heart failure requiring therapy
- No ventricular arrhythmia requiring therapy
- No unstable angina pectoris
- No myocardial infarction within the past 6 months
Other
- Able to swallow oral medication
- No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
- No known malabsorption condition or other condition that would impair absorption of study drug
- No active infection
- No other concurrent medical condition that would preclude study
- No known severe hypersensitivity to ZD 1839 or any excipients
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy except in adjuvant setting
- No concurrent chemotherapy for breast cancer
Endocrine therapy
- See Disease Characteristics
- More than 30 days since other prior hormonal therapy (including hormone replacement therapy and megestrol)
- Concurrent steroids for other reasons besides skin toxicity allowed
- No other concurrent hormonal therapy (including megestrol) for breast cancer
Radiotherapy
- See Disease Characteristics
Surgery
- Recovered from prior oncologic or other major surgery
- No concurrent ophthalmic surgery
Other
- More than 30 days since prior anticancer therapy
- More than 30 days since prior non-approved or investigational drugs
- No prior epidermal growth factor receptor or HER2 blockers
- No concurrent phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, Hypericum perforatum, or systemic retinoids
- No other concurrent investigational therapy for breast cancer
- Concurrent bisphosphonates for metastatic bone disease allowed
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Therapy and Research Center
San Antonio, Texas, 78229
About this study
Official title: A Phase II And Biologic Correlative Study Investigating ARIMIDEX In Combination With IRESSA (ZD1839) In Post-Menopausal Patients With Estrogen Receptor-Positive Metastatic Breast Carcinoma Who Have Previously Failed Hormonal Therapy
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in treating postmenopausal women who have metastatic breast cancer that has not responded to hormone therapy.
Read the detailed description
OBJECTIVES:
- Determine the antitumor activity of anastrozole and ZD 1839, as measured by objective response (partial or complete) or stable disease at 6 months, in post-menopausal women with estrogen receptor-positive, hormone refractory, metastatic breast cancer.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Correlate molecular markers with clinical benefit in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients are stratified according to prior objective response to endocrine therapy (yes vs no).
Patients receive oral anastrozole once daily alone for 2 weeks. Patients then receive oral anastrozole and oral ZD 1839 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then monthly thereafter.
PROJECTED ACCRUAL: A total of 36-78 patients (18-39 per stratum) will be accrued for this study.
- Conditions
- Breast Cancer
- Being tested
- anastrozole, gefitinib
- Keywords
- recurrent 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2003 (estimated)
- Study startSep 2002
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 The University of Texas Health Science Center at San AntonioThe 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)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric K. Rowinsky, MD, Study chair, Cancer Therapy and Research Center, Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00049062
- Sponsor's protocol ID
- CDR0000257752
- Other IDs
- CTRC-IDD-0219, CTRC-IDD-1839US, CTRC-IDD-0228
- Status last verified
- Feb 2013
- First submitted
- 12 Nov 2002
- Last updated
- 21 Feb 2013
- Results posted
- No
Publications
Mita M, de Bono JS, Mita A, et al.: A phase II and biologic correlative study investigating anastrozole (A) in combination with geftinib (G) in post menopausal patients with estrogen receptor positive (ER) metastatic breast carcinoma (MBC) who have previously failed hormonal therapy. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1117, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II And Biologic Correlative Study Investigating ARIMIDEX In Combination With IRESSA (ZD1839) In Post-Menopausal Patients With Estrogen Receptor-Positive Metastatic Breast Carcinoma Who Have Previously Failed Hormonal Therapy
- ClinicalTrials.gov ID
- NCT00049062
- Acronym / sponsor ID
- CDR0000257752
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Sep 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 27 Jan 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. Anastrozole may fight breast cancer by blocking the production of estrogen by the tumor cells. Biological therapies such as ZD 1839 may interfere with the growth of the tumor cells and slow the growth of advanced solid tumors. Combining anastrozole with ZD 1839 may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining anastrozole with ZD 1839 in treating postmenopausal women who have metastatic breast cancer that has not responded to hormone therapy.
Detailed description
OBJECTIVES:
- Determine the antitumor activity of anastrozole and ZD 1839, as measured by objective response (partial or complete) or stable disease at 6 months, in post-menopausal women with estrogen receptor-positive, hormone refractory, metastatic breast cancer.
- Determine the progression-free and overall survival of patients treated with this regimen.
- Determine the safety of this regimen in these patients.
- Determine the pharmacokinetics of this regimen in these patients.
- Correlate molecular markers with clinical benefit in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter study.
Patients are stratified according to prior objective response to endocrine therapy (yes vs no).
Patients receive oral anastrozole once daily alone for 2 weeks. Patients then receive oral anastrozole and oral ZD 1839 once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed at 1 month and then monthly thereafter.
PROJECTED ACCRUAL: A total of 36-78 patients (18-39 per stratum) will be accrued for this study.
Study design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- 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 |
|---|---|---|
| anastrozole | Drug | – |
| 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 21 Feb 2013.
- Results publicationMita M, de Bono JS, Mita A, et al.: A phase II and biologic correlative study investigating anastrozole (A) in combination with geftinib (G) in post menopausal patients with estrogen receptor positive (ER) metastatic breast carcinoma (MBC) who have previously failed hormonal therapy. [Abstract] Breast Cancer Research and Treatment 94 (Suppl 1): A-1117, 2005.
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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.
Eric K. Rowinsky, MD study chair
Cancer Therapy and Research Center, Texas
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 anastrozole and gefitinib in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
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 21 Feb 2013. 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 United States. 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?
On the ClinicalTrials.gov record for NCT00049062, which also lists 1 linked publication.
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 21 Feb 2013.