Ductal Carcinoma in SituNCT00857714
Lapatinib for Treatment of Ductal Carcinoma In Situ (DCIS) of the Breast
A study testing lapatinib in people with Ductal Carcinoma in Situ, run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to establish the utility of lapatinib in the treatment of DCIS, particularly ER-negative DCIS. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ductal Carcinoma in Situ
- What is being tested?
- lapatinib
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age greater than or equal to 18 years.
- Patients with operable, biopsy-proven DCIS detected by screening mammography.
- ER/PR negative DCIS.
- DCIS that is positive for HER-2 \&/or EGFR, which is defined as IHC 3+.
- Women of childbearing potential willing to use an accepted and effective barrier method of contraception.
- ECOG performance status ≤2
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- Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram.
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must have normal organ and marrow function as defined below:
- leukocytes ≥3,000/microL
- absolute neutrophil count ≥1,500/microL
- platelets ≥100,000/microL
- total bilirubin within normal institutional limits
- AST (SGOT)/ALT(SGPT) within normal institutional limits
- creatinine within normal institutional limits OR creatinine clearance greater than or equal to 60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (using Cockcroft-Gault formula)
Who cannot join
- Invasive breast cancer
- ER+ or PR+ DCIS
- Pregnant or breast feeding women
- Patients who have had prior treatment with EGFR targeting therapies.
- Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded one week before starting lapatinib and for the duration of lapatinib therapy.
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
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- HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with lapatinib.
- Have ANY hepatic or biliary disease or dysfunction.
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis).
- Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors.
- ANY history of cardiac disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lapatinib in the Treatment of Ductal Carcinoma in Situ of the Breast
The purpose of this study is to establish the utility of lapatinib in the treatment of DCIS, particularly ER-negative DCIS.
Read the detailed description
Ductal carcinoma in situ (DCIS) of the breast is a pre-malignant lesion of the breast, which is associated with a marked increase in the likelihood of developing invasive breast cancer. Since DCIS tends to be associated with microcalcifications, it is detected with an increased frequency in patients being screened with mammographic techniques. The treatment of DCIS is based on a number of parameters; local treatment depends on the size of the lesion, grade and margins. The only systemic treatment currently available is in the form of endocrine therapy; it depends on the expression of estrogen receptor (ER). Randomized trials have shown that the treatment of DCIS with breast conserving therapy and radiation is as effective as simple mastectomy.
The efficacy of tamoxifen in reducing the incidence of further invasive or non-invasive breast cancer has been established. In addition to surgery (with or without radiation), patients with ER positive disease also receive anti-estrogen therapy. Current guidelines do not recommend any additional therapy for ER-negative DCIS.
The rationale for the proposed study is based on the observations that HER2 is expressed at high levels in higher grades of DCIS, which typically lack ER. In addition, an inverse relationship between ER expression and the expression of EGFR has also been demonstrated. Lapatinib is active against both these receptors and may have therapeutic action in ER negative DCIS.
We propose to treat the patients with drug in the interval between biopsy diagnosis and definitive surgery.
- Conditions
- Ductal Carcinoma in Situ
- Being tested
- lapatinib
- Keywords
- DCIS, breast
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinibDrug
Also called Tykerb
1500 mg lapatinib for 14-21 days
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Where Gene Signature Was Obtained.
Number of patients where gene signature was obtained. This was used to identify gene signature that denotes effect of lapatinib therapy in breast cancer cell lines and to assess effect of lapatinib therapy in patients with ductal carinoma in situ of the breast using the gene signature developed as a surrogate marker.
Measured: Up to 60 days
Secondary outcomes (1)
Number of Patients With Toxicity Associated With Short Therapy With Lapatinib.
Number of patients with toxicity associated with short therapy with lapatinib will be reported.
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionAug 2010
- Study completionAug 2010
Why it stopped: Terminated due to low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ductal Carcinoma in SituStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Sunil Badve, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00857714
- Sponsor's protocol ID
- 0812-11
- Status last verified
- Jun 2015
- First submitted
- 6 Mar 2009
- Last updated
- 8 Jul 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lapatinib in the Treatment of Ductal Carcinoma in Situ of the Breast
- ClinicalTrials.gov ID
- NCT00857714
- Acronym / sponsor ID
- 0812-11
- Conditions
- Ductal Carcinoma in Situ
- Keywords
- DCIS, breast
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to low accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Apr 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Mar 2009 (estimated)
- Results
- Posted 8 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the utility of lapatinib in the treatment of DCIS, particularly ER-negative DCIS.
Detailed description
Ductal carcinoma in situ (DCIS) of the breast is a pre-malignant lesion of the breast, which is associated with a marked increase in the likelihood of developing invasive breast cancer. Since DCIS tends to be associated with microcalcifications, it is detected with an increased frequency in patients being screened with mammographic techniques. The treatment of DCIS is based on a number of parameters; local treatment depends on the size of the lesion, grade and margins. The only systemic treatment currently available is in the form of endocrine therapy; it depends on the expression of estrogen receptor (ER). Randomized trials have shown that the treatment of DCIS with breast conserving therapy and radiation is as effective as simple mastectomy.
The efficacy of tamoxifen in reducing the incidence of further invasive or non-invasive breast cancer has been established. In addition to surgery (with or without radiation), patients with ER positive disease also receive anti-estrogen therapy. Current guidelines do not recommend any additional therapy for ER-negative DCIS.
The rationale for the proposed study is based on the observations that HER2 is expressed at high levels in higher grades of DCIS, which typically lack ER. In addition, an inverse relationship between ER expression and the expression of EGFR has also been demonstrated. Lapatinib is active against both these receptors and may have therapeutic action in ER negative DCIS.
We propose to treat the patients with drug in the interval between biopsy diagnosis and definitive surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 (15 listed)
- Age greater than or equal to 18 years.
- Patients with operable, biopsy-proven DCIS detected by screening mammography.
- ER/PR negative DCIS.
- DCIS that is positive for HER-2 \&/or EGFR, which is defined as IHC 3+.
- Women of childbearing potential willing to use an accepted and effective barrier method of contraception.
Key exclusion criteria (11 listed)
- Invasive breast cancer
- ER+ or PR+ DCIS
- Pregnant or breast feeding women
- Patients who have had prior treatment with EGFR targeting therapies.
- Patients may not be receiving any other investigational agents or receiving concurrent anticancer therapy. In addition, all herbal (alternative) medicines are excluded one week before starting lapatinib and for the duration of lapatinib therapy.
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 |
|---|---|---|
| lapatinibAlso: Tykerb1500 mg lapatinib for 14-21 days | Drug | – |
Primary outcome
Number of Patients Where Gene Signature Was Obtained.
Time frame: Up to 60 days
Number of patients where gene signature was obtained. This was used to identify gene signature that denotes effect of lapatinib therapy in breast cancer cell lines and to assess effect of lapatinib therapy in patients with ductal carinoma in situ of the breast using the gene signature developed as a surrogate marker.
1 secondary outcome
Number of Patients With Toxicity Associated With Short Therapy With Lapatinib.
Time frame: Up to 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Addressing Financial Hardship in AYA Cancer Survivors Through the Use of the New LIFT UP Intervention
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DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
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Active, not recruitingPhase 3
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
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.
Sunil Badve, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lapatinib in people with Ductal Carcinoma in Situ, run by Indiana University 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 15 inclusion and 11 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 8 Jul 2015. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients Where Gene Signature Was Obtained. (time frame: Up to 60 days). 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 8 Jul 2015.