BREAST CANCERPhase 2NCT00206414
Arimidex/Faslodex/Iressa Study: A Trial Using Arimidex, Faslodex and Iressa in Women With Breast Cancer
A Phase 2 study testing Iressa Day 1 given with Arimidex and Faslodex and Iressa Day 21 given with Arimidex and Faslodex in people with BREAST CANCER, run by Baylor Breast Care Center at 1 site in United States.
Trial summary
The investigators want to know if combining Arimidex and Faslodex with Iressa will be an effective treatment for breast cancer. They also want to know, using special tests on the tumor, the changes that occur with the treatment so they can try to improve their treatment for breast cancer in the future. 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?
- Iressa Day 1 given with Arimidex and Faslodex and Iressa Day 21 given with Arimidex and Faslodex
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2003to Sep 2006
- 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
- All subjects must be female
- Postmenopausal status, defined as any one of the following criteria:
- documented history of bilateral oophorectomy;
- age 60 years or more;
- ages 45 to 59 and satisfying one or more of the following criteria:
- amenorrhea for at least 12 months and intact uterus;
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- amenorrhea for less than 12 months and a follicle stimulating hormone (FSH) concentration within premenopausal range including:
- patients who have had a hysterectomy;
- patients who have received hormone replacement.
- Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.
- Estrogen receptor and/or progesterone receptor positive disease
- Patients must not have received any prior treatment for current or newly diagnosed breast cancer.
- Patients must have not received previous treatment with any of the study medications or similar drugs.
- No use of selective estrogen receptor modulators (SERM) such as raloxifene or similar agents in the past 2 years.
- World Health Organization (WHO) performance status of 0, 1, or 2
- Adequate organ function defined as follows:
- adequate renal function, defined by a serum creatinine within 3 times the upper limits of normal;
- adequate liver function, defined by total bilirubin, AST, ALT, and alkaline phosphatase within 3 times the upper limits of normal;
- adequate bone marrow function, defined as a white blood cell (WBC) > 3.0 ml, platelet (PLT) > 75,000/ul, hemoglobin (Hb) > 9 gm/l
- Willing to undergo breast core biopsies as required by the study protocol
- Ability to understand and sign a written informed consent for participation in the trial
- Life expectancy of at least 1 year.
Who cannot join
- Known severe hypersensitivity to Iressa or any of the excipients of this product
- Premenopausal status
- Patients with synchronous bilateral breast cancer
- Patients with diffuse tumors that cannot be clearly measurable, such as inflammatory breast cancer
- Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ
- Patients with brain metastasis
Show all 17Show fewer
- WHO performance status of 3 or 4
- As judged by the investigator, uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the clinical trial.
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St. John's wort
- Concurrent treatment with estrogens or progestins. Patients must stop these drugs at least two weeks prior to study entry.
- Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment
- Platelet count less than 75,000
- In the opinion of the investigator, bleeding diathesis or anticoagulation therapy that would preclude intramuscular injections.
- History of hypersensitivity to castor oil
- Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded).
- Patients with recurrent breast cancer. Patients with contralateral second primary breast cancers are eligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Arimidex/Faslodex/Iressa Study: A Phase II Trial of Primary Systemic Therapy Using a Combination of Arimidex, Faslodex and Iressa (Gefitinib) in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
The investigators want to know if combining Arimidex and Faslodex with Iressa will be an effective treatment for breast cancer. They also want to know, using special tests on the tumor, the changes that occur with the treatment so they can try to improve their treatment for breast cancer in the future.
Read the detailed description
Over the last three decades, a steady shift has occurred in the management of breast cancer. Because it was traditionally viewed as a local disease, many advocated the use of radical surgery to achieve maximum survival benefit. This view has been slowly replaced by a broader biologic view that recognizes the often systemic nature of breast cancer, even when it appears to be localized to the breast. Results from randomized clinical trials have demonstrated that less extensive surgery or lumpectomy plus radiation therapy are optimal for local management of early breast cancer. In addition to the less radical approach to surgical treatment of breast cancer, other randomized clinical trials established the value of postoperative (adjuvant) systemic therapy in improving overall survival by eradicating micrometastatic disease, the major cause of mortality from breast cancer. An improved survival has been shown from using chemotherapy as well as the antiestrogen tamoxifen in the adjuvant setting and has been confirmed through the overview analyses from the Early Breast Cancer Trialist Collaborative Group. Despite the well-documented benefits of adjuvant systemic therapy, it is not effective in preventing death from breast cancer in all patients who are candidates for such treatment. The worth of such therapy can only be judged in retrospect upon disease relapse, a time when breast cancer is nearly always incurable. Currently, there are few reliable methods to predict the success or failure of a particular postoperative treatment modality and better ways to predict and optimize outcome are needed. Preoperative (primary, neoadjuvant) systemic therapy is an alternative approach that is based on a strong rationale. With the tumor still in place and directly accessible, this form of therapy allows direct observation of response to treatment which may predict the likelihood of controlling distant micrometastatic disease and also enables the sampling of tissue to explore molecular correlates of response and also the mechanisms of action of therapeutic agents. Furthermore, it allows early identification of patients with refractory disease who might benefit from alternative treatments before they develop macrometastatic disease and miss the opportunity for a cure. Primary systemic therapy can also help facilitate surgery and debulking of disease in those patients with initially inoperable tumors, as well as improve the odds of breast conservation.
A pivotal trial that established the role of preoperative systemic therapy was the NSABP trial B-187. In this trial, women with localized breast cancer were randomized to receive Adriamycin, Cytoxan (AC) either preoperatively or postoperatively. There was no difference between the two groups in disease-free and overall survival. Furthermore, quantifying tumor response preoperatively allowed prediction of patient outcome in terms of disease-free and overall survival. Specifically, patients achieving a pathologic complete response, i.e., complete disappearance of invasive cancer on pathologic examination, had the best outcome, establishing the role of response as a valid surrogate predictor of the sensitivity of distant micrometastatic disease to chemotherapy and subsequent clinical outcome. In addition, breast-conserving surgery was more frequently performed in the preoperative treatment group, an advantage over the postoperative treatment approach. Most importantly, however, NSABP trial B-18 showed conclusively that primary systemic therapy is safe and does not place patients at a disadvantage by delaying primary surgical treatment. Another large, multicenter prospective trial conducted by the European Organization for Research and Treatment of Cancer (EORTC) confirmed the findings of NSABP trial B-18.
Primary study objective:
- To determine the clinical response rate of primary breast cancer to the combination of Arimidex, Faslodex, and Iressa
Secondary study objectives:
- To study molecular changes in response to treatment
- To determine the pathologic response rate
- To assess the tolerability and safety of the combination regimen
- Conditions
- BREAST CANCER
- Being tested
- Iressa Day 1 given with Arimidex and Faslodex, Iressa Day 21 given with Arimidex and Faslodex
- Keywords
- HORMONE RECEPTOR POSITIVE 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.
Iressa Day 1 given with Arimidex and FaslodexDrug
Also called gefitinib
timing of administration of iressa is the study factor
Iressa Day 21 given with Arimidex and FaslodexDrug
Also called gefitninb
Timing of Iressa is the study factor
| Study group | Role | What they receive |
|---|---|---|
| Iressa Day 1 with Arimidex and Faslodex | Experimental | Subjects randomized to Iressa on Day 1 in combination with Arimidex and Faslodex. Receives: Drug: Iressa Day 1 given with Arimidex and Faslodex |
| Iressa Day 21 with Arimidex and Faslodex | Active comparator | Subjects randomized to Iressa Day 21 in combination with Arimidex and Faslodex Receives: Drug: Iressa Day 21 given with Arimidex and Faslodex |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary study objective - To determine the clinical response rate of primary breast cancer to the combination of Arimidex, Faslodex, and Iressa
Measured: until disdase progression
Secondary outcomes (1)
Secondary study objectives - To study molecular changes in response to treatment, to determine the pathologic response rate, and to assess the tolerability and safety of the combination regimen
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJan 2003
- Primary completionSep 2006
- Study completionSep 2006
Why it stopped: Difficulty accruing subjects the study accrual was closed
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.
- 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
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Breast Care Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mothaffar Rimawi, MD, Principal investigator, Baylor Breast Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00206414
- Sponsor's protocol ID
- H-14732
- Status last verified
- Feb 2013
- First submitted
- 12 Sep 2005
- Last updated
- 5 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Massarweh S, Tham YL, Huang J, Sexton K, Weiss H, Tsimelzon A, Beyer A, Rimawi M, Cai WY, Hilsenbeck S, Fuqua S, Elledge R. A phase II neoadjuvant trial of anastrozole, fulvestrant, and gefitinib in patients with newly diagnosed estrogen receptor positive breast cancer. Breast Cancer Res Treat. 2011 Oct;129(3):819-27. doi: 10.1007/s10549-011-1679-8. Epub 2011 Jul 27.
PubMed 21792626
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arimidex/Faslodex/Iressa Study: A Phase II Trial of Primary Systemic Therapy Using a Combination of Arimidex, Faslodex and Iressa (Gefitinib) in Postmenopausal Women With Hormone Receptor Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00206414
- Acronym / sponsor ID
- H-14732
- Conditions
- BREAST CANCER
- Keywords
- HORMONE RECEPTOR POSITIVE BREAST CANCER
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty accruing subjects the study accrual was closed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Baylor Breast Care CenterUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 21 Sep 2005 (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.
The investigators want to know if combining Arimidex and Faslodex with Iressa will be an effective treatment for breast cancer. They also want to know, using special tests on the tumor, the changes that occur with the treatment so they can try to improve their treatment for breast cancer in the future.
Detailed description
Over the last three decades, a steady shift has occurred in the management of breast cancer. Because it was traditionally viewed as a local disease, many advocated the use of radical surgery to achieve maximum survival benefit. This view has been slowly replaced by a broader biologic view that recognizes the often systemic nature of breast cancer, even when it appears to be localized to the breast. Results from randomized clinical trials have demonstrated that less extensive surgery or lumpectomy plus radiation therapy are optimal for local management of early breast cancer. In addition to the less radical approach to surgical treatment of breast cancer, other randomized clinical trials established the value of postoperative (adjuvant) systemic therapy in improving overall survival by eradicating micrometastatic disease, the major cause of mortality from breast cancer. An improved survival has been shown from using chemotherapy as well as the antiestrogen tamoxifen in the adjuvant setting and has been confirmed through the overview analyses from the Early Breast Cancer Trialist Collaborative Group. Despite the well-documented benefits of adjuvant systemic therapy, it is not effective in preventing death from breast cancer in all patients who are candidates for such treatment. The worth of such therapy can only be judged in retrospect upon disease relapse, a time when breast cancer is nearly always incurable. Currently, there are few reliable methods to predict the success or failure of a particular postoperative treatment modality and better ways to predict and optimize outcome are needed. Preoperative (primary, neoadjuvant) systemic therapy is an alternative approach that is based on a strong rationale. With the tumor still in place and directly accessible, this form of therapy allows direct observation of response to treatment which may predict the likelihood of controlling distant micrometastatic disease and also enables the sampling of tissue to explore molecular correlates of response and also the mechanisms of action of therapeutic agents. Furthermore, it allows early identification of patients with refractory disease who might benefit from alternative treatments before they develop macrometastatic disease and miss the opportunity for a cure. Primary systemic therapy can also help facilitate surgery and debulking of disease in those patients with initially inoperable tumors, as well as improve the odds of breast conservation.
A pivotal trial that established the role of preoperative systemic therapy was the NSABP trial B-187. In this trial, women with localized breast cancer were randomized to receive Adriamycin, Cytoxan (AC) either preoperatively or postoperatively. There was no difference between the two groups in disease-free and overall survival. Furthermore, quantifying tumor response preoperatively allowed prediction of patient outcome in terms of disease-free and overall survival. Specifically, patients achieving a pathologic complete response, i.e., complete disappearance of invasive cancer on pathologic examination, had the best outcome, establishing the role of response as a valid surrogate predictor of the sensitivity of distant micrometastatic disease to chemotherapy and subsequent clinical outcome. In addition, breast-conserving surgery was more frequently performed in the preoperative treatment group, an advantage over the postoperative treatment approach. Most importantly, however, NSABP trial B-18 showed conclusively that primary systemic therapy is safe and does not place patients at a disadvantage by delaying primary surgical treatment. Another large, multicenter prospective trial conducted by the European Organization for Research and Treatment of Cancer (EORTC) confirmed the findings of NSABP trial B-18.
Primary study objective:
- To determine the clinical response rate of primary breast cancer to the combination of Arimidex, Faslodex, and Iressa
Secondary study objectives:
- To study molecular changes in response to treatment
- To determine the pathologic response rate
- To assess the tolerability and safety of the combination regimen
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iressa Day 1 with Arimidex and Faslodex | Experimental | Drug: Iressa Day 1 given with Arimidex and FaslodexSubjects randomized to Iressa on Day 1 in combination with Arimidex and Faslodex. |
| Iressa Day 21 with Arimidex and Faslodex | Active comparator | Drug: Iressa Day 21 given with Arimidex and FaslodexSubjects randomized to Iressa Day 21 in combination with Arimidex and Faslodex |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- All subjects must be female
- Postmenopausal status, defined as any one of the following criteria:
- Patients must have histologically confirmed invasive breast cancer with a primary tumor of 3 cm or more in greatest dimension as measured by clinical examination.
- Estrogen receptor and/or progesterone receptor positive disease
- Patients must not have received any prior treatment for current or newly diagnosed breast cancer.
Key exclusion criteria (17 listed)
- Known severe hypersensitivity to Iressa or any of the excipients of this product
- Premenopausal status
- Patients with synchronous bilateral breast cancer
- Patients with diffuse tumors that cannot be clearly measurable, such as inflammatory breast cancer
- Other coexisting malignancies with the exception of basal cell carcinoma or cervical cancer in situ
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 |
|---|---|---|
| Iressa Day 1 given with Arimidex and FaslodexAlso: gefitinibtiming of administration of iressa is the study factor | Drug | Iressa Day 1 with Arimidex and Faslodex |
| Iressa Day 21 given with Arimidex and FaslodexAlso: gefitninbTiming of Iressa is the study factor | Drug | Iressa Day 21 with Arimidex and Faslodex |
Primary outcome
Primary study objective - To determine the clinical response rate of primary breast cancer to the combination of Arimidex, Faslodex, and Iressa
Time frame: until disdase progression
1 secondary outcome
Secondary study objectives - To study molecular changes in response to treatment, to determine the pathologic response rate, and to assess the tolerability and safety of the combination regimen
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Difficulty accruing subjects the study accrual was closed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2013.
- Derived from this study: PubMed 21792626Massarweh S, Tham YL, Huang J, Sexton K, Weiss H, Tsimelzon A, Beyer A, Rimawi M, Cai WY, Hilsenbeck S, Fuqua S, Elledge R. A phase II neoadjuvant trial of anastrozole, fulvestrant, and gefitinib in patients with newly diagnosed estrogen receptor positive breast cancer. Breast Cancer Res Treat. 2011 Oct;129(3):819-27. doi: 10.1007/s10549-011-1679-8. Epub 2011 Jul 27.
- Web SiteLink 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.
Mothaffar Rimawi, MD principal investigator
Baylor Breast Center
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 Iressa Day 1 given with Arimidex and Faslodex and Iressa Day 21 given with Arimidex and Faslodex in people with BREAST CANCER, run by Baylor Breast Care Center 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?
The sponsor lists 22 inclusion and 17 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: stopped early, as of the sponsor's last update on 5 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 was stopped early (reason given: Difficulty accruing subjects the study accrual was closed). Results are not available in the source record.
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?
Primary study objective - To determine the clinical response rate of primary breast cancer to the combination of Arimidex, Faslodex, and Iressa (time frame: until disdase progression). 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 NCT00206414, 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 5 Feb 2013.