Breast CancerPhase 2NCT00109265
A Study to Evaluate Erlotinib in Patients With Advanced or Metastatic Breast Cancer During or Following Chemotherapy
A Phase 2 study testing Erlotinib HCl (OSI-774) in people with Breast Cancer, run by Genentech, Inc..
Trial summary
This is a Phase II, multicenter trial of single-agent treatment with OSI 774 in patients with histologically confirmed, incurable, locally advanced or metastatic breast cancer. Patients must have measurable disease. 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?
- Erlotinib HCl (OSI-774)
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- May 2001to Oct 2002
- 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
- Signed informed consent
- Women >=18 years of age
- Histologically documented, incurable, locally advanced or metastatic breast cancer
- Disease progression on or after therapy with an anthracycline, a taxane, and capecitabine (Cohort 1), or disease progression on or after therapy with at least one chemotherapy regimen for locally advanced or metastatic disease (Cohort 2)
- Measurable disease of >=2 cm (>=1 cm on spiral CT scan). Disease at previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy.
- HER2 negative, HER2 unknown, or HER2 positive and disease progression following Herceptin(R) (trastuzumab) therapy
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- ECOG performance status of 0 to 2
- Life expectancy of >=3 months
- Use of effective means of contraception in women of childbearing potential
- Ability to comply with study and follow-up procedures
Who cannot join
- Pleural effusions or blastic bone lesions as the only manifestations of the current metastatic breast cancer
- Other primary malignancies within 5 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
- Symptomatic or untreated brain metastases
- Radiotherapy, immunotherapy, hormonal therapy, or chemotherapy within 21 days prior to Day 0 (6 weeks for nitrosoureas or mitomycin); prior therapy with an agent designed to target either the EGFR or EGFR-specific tyrosine kinase activity
- INR >4.0 for patients receiving warfarin
- Cumulative anthracycline and anthracenedione exposure as follows: doxorubicin >450 mg/m, liposomal doxorubicin >550 mg/m, epirubicin >700 mg/m, or mitoxantrone >140 mg/m
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- Cardiac ejection fraction (MUGA or echocardiogram) less than the local institution lower limit of normal
- Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 0, or serious cardiac arrhythmia requiring medication
- Major surgery, biopsy of a parenchymal organ, or significant traumatic injury occurring within 21 days prior to Day 0
- History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications
- Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogren's syndrome), congenital abnormality (e.g., Fuch's dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease
- Pregnancy or lactation
- Any of the following abnormal baseline hematologic values: *Granulocyte count <=1500/uL; *Platelet count <100,000/uL; *Hemoglobin <9 gm/dL (transfusion permitted)
- Any of the following abnormal baseline liver function tests: *Serum bilirubin >=1.5x upper limit of normal (ULN); *Serum ALT and AST >=2.5x ULN (>5x ULN if due to liver metastases); *Alkaline phosphatase >=2.5x ULN (>4x ULN if due to liver or bone metastases)
- Other baseline laboratory values: *Serum creatinine >=1.5x ULN or creatinine clearance <=60 mL/min; *Uncontrolled hypercalcemia (>11.5 mg/dL); *Serum albumin <=3.0 g/dL
About this study
Official title: A Phase II, Multicenter, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of OSI-774 in Patients With Advanced or Metastatic Breast Cancer and Disease Progression During or Following Chemotherapy
This is a Phase II, multicenter trial of single-agent treatment with OSI 774 in patients with histologically confirmed, incurable, locally advanced or metastatic breast cancer. Patients must have measurable disease.
- Conditions
- Breast Cancer
- Being tested
- Erlotinib HCl (OSI-774)
- Keywords
- Advanced Breast Cancer, Metastatic Breast Cancer, Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erlotinib HCl (OSI-774)Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2005 (estimated)
- Study startMay 2001
- Study completionOct 2002
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 Genentech, Inc.The 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
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00109265
- Sponsor's protocol ID
- OSI2288g
- Status last verified
- Jun 2013
- First submitted
- 26 Apr 2005
- Last updated
- 2 Jul 2015
- Results posted
- No
Publications
Dickler MN, Cobleigh MA, Miller KD, Klein PM, Winer EP. Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer. Breast Cancer Res Treat. 2009 May;115(1):115-21. doi: 10.1007/s10549-008-0055-9. Epub 2008 May 22.
PubMed 18496750
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Open-Label Clinical Trial to Evaluate the Efficacy and Safety of OSI-774 in Patients With Advanced or Metastatic Breast Cancer and Disease Progression During or Following Chemotherapy
- ClinicalTrials.gov ID
- NCT00109265
- Acronym / sponsor ID
- OSI2288g
- Conditions
- Breast Cancer
- Keywords
- Advanced Breast Cancer, Metastatic Breast Cancer, Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2001
- Study completion
- Oct 2002 (actual)
- First posted
- 26 Apr 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.
This is a Phase II, multicenter trial of single-agent treatment with OSI 774 in patients with histologically confirmed, incurable, locally advanced or metastatic breast cancer. Patients must have measurable disease.
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
Key inclusion criteria (10 listed)
- Signed informed consent
- Women >=18 years of age
- Histologically documented, incurable, locally advanced or metastatic breast cancer
- Disease progression on or after therapy with an anthracycline, a taxane, and capecitabine (Cohort 1), or disease progression on or after therapy with at least one chemotherapy regimen for locally advanced or metastatic disease (Cohort 2)
- Measurable disease of >=2 cm (>=1 cm on spiral CT scan). Disease at previously irradiated sites is considered measurable if there is clear disease progression following radiation therapy.
Key exclusion criteria (16 listed)
- Pleural effusions or blastic bone lesions as the only manifestations of the current metastatic breast cancer
- Other primary malignancies within 5 years except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
- Symptomatic or untreated brain metastases
- Radiotherapy, immunotherapy, hormonal therapy, or chemotherapy within 21 days prior to Day 0 (6 weeks for nitrosoureas or mitomycin); prior therapy with an agent designed to target either the EGFR or EGFR-specific tyrosine kinase activity
- INR >4.0 for patients receiving warfarin
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 |
|---|---|---|
| Erlotinib HCl (OSI-774) | 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 2 Jul 2015.
- Results publication: PubMed 18496750Dickler MN, Cobleigh MA, Miller KD, Klein PM, Winer EP. Efficacy and safety of erlotinib in patients with locally advanced or metastatic breast cancer. Breast Cancer Res Treat. 2009 May;115(1):115-21. doi: 10.1007/s10549-008-0055-9. Epub 2008 May 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Erlotinib HCl (OSI-774) in people with Breast Cancer, run by Genentech, Inc..
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 10 inclusion and 16 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 2 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
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 NCT00109265, 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 2 Jul 2015.