Breast CancerPhase 2NCT00077025
Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer
A Phase 2 study testing Gefitinib and Anastrozole in people with Breast Cancer, run by AstraZeneca at 27 sites in 4 countries.
Trial summary
This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer. 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?
- Gefitinib and Anastrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 27 sitesin 4 countries
- Study dates
- Jan 2004to May 2013
- 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
Who may be able to join
- Female postmenopausal patients aged 18 years or older with newly diagnosed metastatic breast cancer.
- Patients with recurrent disease during or after adjuvant tamoxifen or patients who are hormone therapy naïve are eligible for this trial.
- A paraffin embedded tumor tissue block or slides from either the metastatic or primary tumor site is required.
Who cannot join
- Patients cannot be on hormone replacement therapy while on study.
- Prior chemotherapy received for metastatic disease is not allowed.
- Previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not allowed.
- Patients who have evidence of an active interstitial lung disease are not eligible.
Trial locations and contacts
27 sites in 4 countries.
27 sites in 4 countries
United States16 sites
Research Site
Albuquerque, New Mexico
Research Site
Allentown, Pennsylvania
Research Site
Cincinnati, Ohio
Research Site
Columbia, Missouri
Research Site
Houston, Texas
Research Site
La Jolla, California
Research Site
Lafayette, Louisiana
Research Site
Lake Success, New York
Research Site
Las Vegas, Nevada
Research Site
Omaha, Nebraska
Research Site
Orlando, Florida
Research Site
Rockville, Maryland
Research Site
San Diego, California
Research Site
Sioux Falls, South Dakota
Research Site
Temple, Texas
Research Site
Voorhees Township, New Jersey
Venezuela7 sites
Research Site
Barcelona
Research Site
Barquisimeto
Research Site
Caracas
Research Site
Maracaibo
Research Site
Puerto Ordaz and San Felix
Research Site
San Cristóbal
Research Site
Valencia
Mexico3 sites
Research Site
Aguascalientes
Research Site
Guadalajara
Research Site
Morelia
About this study
Official title: Phase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, Arimidex™)-Placebo to the Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer
This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer.
Read the detailed description
This is a phase II, multicenter, double-blind, randomized, placebo-controlled trial. Patients will be randomized in a double-blind manner in a 1:1 ratio to receive either 250 mg/day ZD1839 or matched placebo in combination with 1 mg/day anastrozole. The dose of ZD1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mg/day. The 1 mg dose of anastrozole is the standard approved dose.
- Conditions
- Breast Cancer
- Being tested
- Gefitinib, Anastrozole
- Keywords
- metastatic 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
Also called IRESSA
ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)
AnastrozoleDrug
Also called Arimidex
1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO
| Study group | Role | What they receive |
|---|---|---|
| Anastrozole-placebo | Active comparator | Anastrozole (ZD1033, Arimidex)-Placebo Receives: Drug: Anastrozole |
| Anastrozole-ZD1839 | Active comparator | Anastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA) Receives: Drug: Gefitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer
Measured: Duration of study
Secondary outcomes (6)
Objective response rate
To estimate the ORR (complete response [CR] and partial response [PR] as defined by RECIST for the 2 treatment arms
Measured: Duration of Study
Overall clinical benefit rate
To estimate the clinical benefit rates (CBR; defined as CR+PR[as per RECIST]+stable disease [SD]>24 weeks) for the 2 treatment arms
Measured: Duration of Study
Overall survival
To estimate overall survival (OS) for each of the 2 treatment arms
Measured: Duration of Study
Safety
To compare the tolerability of anastrozole/placebo to that of anastrozole/ZD1839
Measured: Duration of Study
Pharmacokinetic variables
To determine steady-state plasma trough concentrations of anastrozole in all patients. To determine steady-state trough concentrations of ZD1839 and to relate values to historical data
Measured: Duration of Study
Biomarker objectives
To obtain tumor tissue and blood samples for biologic studies in the limited population available and measure expression of markers that may potentially correlate with response to treatment in this patient population
Measured: Duration of Study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2004 (estimated)
- Study startJan 2004
- Primary completionMay 2013
- Study completionMay 2013
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 AstraZenecaThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Iressa Medical Science Director, MD, Study director, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077025
- Sponsor's protocol ID
- 1839US/0713
- Status last verified
- Jul 2014
- First submitted
- 9 Feb 2004
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, Arimidex™)-Placebo to the Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00077025
- Acronym / sponsor ID
- 1839US/0713
- Conditions
- Breast Cancer
- Keywords
- metastatic breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Feb 2004 (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.
This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer.
Detailed description
This is a phase II, multicenter, double-blind, randomized, placebo-controlled trial. Patients will be randomized in a double-blind manner in a 1:1 ratio to receive either 250 mg/day ZD1839 or matched placebo in combination with 1 mg/day anastrozole. The dose of ZD1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mg/day. The 1 mg dose of anastrozole is the standard approved dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anastrozole-placebo | Active comparator | Drug: AnastrozoleAnastrozole (ZD1033, Arimidex)-Placebo |
| Anastrozole-ZD1839 | Active comparator | Drug: GefitinibAnastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female postmenopausal patients aged 18 years or older with newly diagnosed metastatic breast cancer.
- Patients with recurrent disease during or after adjuvant tamoxifen or patients who are hormone therapy naïve are eligible for this trial.
- A paraffin embedded tumor tissue block or slides from either the metastatic or primary tumor site is required.
Key exclusion criteria (4 listed)
- Patients cannot be on hormone replacement therapy while on study.
- Prior chemotherapy received for metastatic disease is not allowed.
- Previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not allowed.
- Patients who have evidence of an active interstitial lung disease are not eligible.
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 |
|---|---|---|
| GefitinibAlso: IRESSAZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex) | Drug | Anastrozole-ZD1839 |
| AnastrozoleAlso: Arimidex1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO | Drug | Anastrozole-placebo |
Primary outcome
Time to progression
Time frame: Duration of study
To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer
6 secondary outcomes
Objective response rate
Time frame: Duration of Study
Overall clinical benefit rate
Time frame: Duration of Study
Overall survival
Time frame: Duration of Study
Safety
Time frame: Duration of Study
Pharmacokinetic variables
Time frame: Duration of Study
Biomarker objectives
Time frame: Duration of Study
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 16 Jul 2014.
- CSR-1839US-0713.pdfLink provided by the sponsor.
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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.
Iressa Medical Science Director, MD study director
AstraZeneca
27 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gefitinib and Anastrozole in people with Breast Cancer, run by AstraZeneca at 27 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. 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 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States, Venezuela, Mexico, Colombia. 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?
Time to progression (time frame: Duration of study). It is what the study was designed to measure, not a finding.
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 16 Jul 2014.