Breast CancerPhase 2NCT00080743
Gefitinib With or Without Tamoxifen in Treating Patients With Tamoxifen-Resistant Metastatic Breast Cancer
A Phase 2 study testing gefitinib and tamoxifen citrate in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. 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 and tamoxifen citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Nov 2005
- 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
- Metastatic disease
- Initial clinical benefit from tamoxifen for metastatic disease, defined by 1 of the following:
- Stable disease for 24 weeks or longer
- Objective tumor response
- Documentation of clinical progression on tamoxifen within the past 6 weeks
- Hormone receptor status:
- Estrogen or progesterone receptor positive on most recently analyzed biopsy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Not specified
Menopausal status
- Not specified
Performance status
- ECOG 0-2
Life expectancy
- At least 6 months
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- AST ≤ 1.5 times upper limit of normal (ULN)
- Bilirubin ≤ 1.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN OR
- Creatinine clearance ≥ 50 mL/min
Pulmonary
- No clinically active interstitial lung disease
- Patients with asymptomatic chronic stable radiographic changes are eligible
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No known hypersensitivity to gefitinib
- No other malignancy within the past 5 years except basal cell carcinoma or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No concurrent trastuzumab (Herceptin®)
Chemotherapy
- No concurrent cytotoxic chemotherapy
Endocrine therapy
- See Disease Characteristics
- At least 2 weeks since other prior tamoxifen
- No concurrent hormone replacement therapy
- No other concurrent antiestrogens, including raloxifene
- No concurrent aromatase inhibitors
- No concurrent megestrol
- Concurrent systemic steroids for reasons other than skin toxicity allowed provided the steroids were initiated before study entry AND dose remains stable
Radiotherapy
- Concurrent palliative radiotherapy as short-term treatment for symptomatic bone metastases allowed provided other evaluable sites of disease are present AND treatment lasts no more than 14 days
Surgery
- Recovered from prior oncologic or other major surgery
- No concurrent surgery during and for 7 days after study treatment
- No concurrent ophthalmic surgery
Other
- Recovered from all prior therapy (except alopecia)
- More than 30 days since prior investigational drugs
- No other concurrent investigational agents
- No concurrent administration of any of the following:
- Phenytoin
- Carbamazepine
- Barbiturates
- Rifampin
- Phenobarbital
- Hypericum perforatum (St. John's wort)
- Systemic retinoids
- CYP3A4 inhibitors (e.g., itraconazole)
- Drugs that cause significant sustained elevation in gastric pH ≥ 5
Trial locations and contacts
1 site in 1 country.
United States1 site
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
Official title: ZD1839 (IRESSA) In Tamoxifen-Resistant Metastatic Breast Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Combining gefitinib with tamoxifen may be effective in killing tumor cells that have become resistant (stopped responding) to tamoxifen.
PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with tamoxifen works compared to gefitinib alone in treating patients with metastatic breast cancer that has stopped responding to tamoxifen.
Read the detailed description
OBJECTIVES:
Primary
- Compare the rate of clinical benefit in patients with tamoxifen-resistant breast cancer treated with gefitinib with or without tamoxifen.
Secondary
- Determine the toxic effects of these regimens in these patients.
- Determine whether changes in fludeoxyglucose F 18 uptake by positron emission tomography scan and changes in plasma DNA levels are indicators of an early response to gefitinib in these patients.
- Determine the pharmacokinetics of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to population (intent-to-treat population comprising all patients who receive 1 dose of treatment vs a subset of the intent-to-treat population, excluding patients with nonmeasurable/evaluable only disease). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tamoxifen once daily. Beginning 14 days after the start of tamoxifen, patients receive oral gefitinib once daily.
- Arm II: Patients receive oral placebo once daily. Beginning 14 days after the start of placebo, patients receive oral gefitinib as in arm I.
In both arms, treatment continues for 26 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 6 months.
PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study within 23 months.
- Conditions
- Breast Cancer
- Being tested
- gefitinib, tamoxifen citrate, Placebo
- Keywords
- recurrent 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.
gefitinibDrug
Also called ZD1839, Iressa
250 mg po once daily
tamoxifen citrateDrug
Also called Nolvadex
20 mg po once daily
PlaceboDrug
Also called Sugar pill
One pill po once daily
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Active comparator | Tamoxifen 20 mg po once daily Receives: Drug: gefitinib; Drug: tamoxifen citrate |
| Placebo | Placebo comparator | Placebo comparator one tablet po once daily Receives: Drug: gefitinib; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical benefit rate (complete response, partial response, and stable disease) for 26 weeks
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2004 (estimated)
- Study startJan 2004
- Primary completionApr 2005
- Study completionNov 2005
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 Dartmouth-Hitchcock Medical CenterThe 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, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Norris Cotton Cancer Center
- Investigators
- Gary N. Schwartz, MD, Principal investigator, Norris Cotton Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00080743
- Sponsor's protocol ID
- CDR0000355145
- Other IDs
- DMS-0236, ZENECA-IRUSIRES0162
- Status last verified
- Aug 2009
- First submitted
- 7 Apr 2004
- Last updated
- 6 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ZD1839 (IRESSA) In Tamoxifen-Resistant Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00080743
- Acronym / sponsor ID
- CDR0000355145
- Conditions
- Breast Cancer
- Keywords
- recurrent breast cancer, stage IV breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Norris Cotton Cancer Center
- Study start
- Jan 2004
- Primary completion
- Apr 2005 (actual)
- Study completion
- Nov 2005 (actual)
- First posted
- 8 Apr 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.
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Combining gefitinib with tamoxifen may be effective in killing tumor cells that have become resistant (stopped responding) to tamoxifen.
PURPOSE: This randomized phase II trial is studying how well giving gefitinib together with tamoxifen works compared to gefitinib alone in treating patients with metastatic breast cancer that has stopped responding to tamoxifen.
Detailed description
OBJECTIVES:
Primary
- Compare the rate of clinical benefit in patients with tamoxifen-resistant breast cancer treated with gefitinib with or without tamoxifen.
Secondary
- Determine the toxic effects of these regimens in these patients.
- Determine whether changes in fludeoxyglucose F 18 uptake by positron emission tomography scan and changes in plasma DNA levels are indicators of an early response to gefitinib in these patients.
- Determine the pharmacokinetics of these regimens in these patients.
OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are stratified according to population (intent-to-treat population comprising all patients who receive 1 dose of treatment vs a subset of the intent-to-treat population, excluding patients with nonmeasurable/evaluable only disease). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral tamoxifen once daily. Beginning 14 days after the start of tamoxifen, patients receive oral gefitinib once daily.
- Arm II: Patients receive oral placebo once daily. Beginning 14 days after the start of placebo, patients receive oral gefitinib as in arm I.
In both arms, treatment continues for 26 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed for 6 months.
PROJECTED ACCRUAL: A total of 46 patients (23 per treatment arm) will be accrued for this study within 23 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen | Active comparator | Drug: gefitinib, Drug: tamoxifen citrateTamoxifen 20 mg po once daily |
| Placebo | Placebo comparator | Drug: gefitinib, Drug: PlaceboPlacebo comparator one tablet po once daily |
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 |
|---|---|---|
| gefitinibAlso: ZD1839, Iressa250 mg po once daily | Drug | Placebo, Tamoxifen |
| tamoxifen citrateAlso: Nolvadex20 mg po once daily | Drug | Tamoxifen |
| PlaceboAlso: Sugar pillOne pill po once daily | Drug | Placebo |
Primary outcome
Clinical benefit rate (complete response, partial response, and stable disease) for 26 weeks
Time frame: 26 weeks
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 6 Aug 2009.
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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.
Gary N. Schwartz, MD principal investigator
Norris Cotton Cancer 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 gefitinib and tamoxifen citrate in people with Breast Cancer, run by Dartmouth-Hitchcock Medical 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?
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 6 Aug 2009. 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. Some participants in this study may receive a placebo. 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?
Clinical benefit rate (complete response, partial response, and stable disease) for 26 weeks (time frame: 26 weeks). 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 6 Aug 2009.