Metastatic Breast CancerPhase 2NCT00759642
Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy
A Phase 2 study testing lapatinib in people with Metastatic Breast Cancer, run by University of Kansas Medical Center at 3 sites in United States.
Trial summary
Hormone receptor positive breast cancer is the most common type of breast cancer, comprising 70-80% of all breast cancers. Endocrine therapy is the main type of initial treatment for patients with your type of breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- lapatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2009to 20 Aug 2018
- Phase
- Phase 2
- 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
- Histologically or cytologically confirmed invasive breast cancer, which at time of study entry is either stage III (locally advanced) disease not amenable to curative therapy or stage IV disease. Histological confirmation of recurrent/metastatic disease is encouraged but not required if clinical evidence of stage IV disease recurrence is available.
- ER and/or Progesterone Receptor (PgR )positive breast cancer (10% or more of infiltrating cancer cells exhibit nuclear staining for ER and/or PgR)
- Have had progressive disease or development of new metastatic disease while on treatment or within 12 months of treatment with an aromatase inhibitor and/or Fulvestrant in adjuvant or metastatic setting
- Have measurable (defined as at least 1 lesion that can be accurately measured in at least 1 dimension [longest diameter to be recorded], with minimum lesion size ≥ 2cm on conventional measurement techniques or ≥ 1cm on spiral computed tomography [CT] scan), or evaluable disease. Patients with lytic or blastic bone disease as only site of disease will be eligible for the study. These patients will be evaluable for progression but not for response.
- Primary tumor was HER-2 negative (IHC 0 or IHC 1+/2+ and Fluorescence in situ hybridization [FISH] ≤ 1.9)
- Patients could have received prior Tamoxifen either as adjuvant therapy or for stage IV disease
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- Performance status of 2 or better per Eastern Cooperative Oncology Group (ECOG) criteria
- Adequate cardiac function (cardiac ejection fraction ≥ 50% as measured by echocardiogram or multigated acquisition (MUGA) scan).
- IV bisphosphonate and denosumab for bony metastatic disease will be allowed
- Palliative radiation therapy to bony metastases will be allowed
- Adequate bone marrow function per good medical practice. Results of these tests do not determine eligibility. Minor deviations are acceptable if they do not impact safety in the judgment of the treating physician. Absolute neutrophil count (ANC) ≥ 1500/mm3, platelet count ≥ 100,000/mm3, and hemoglobin ≥ 10 g/dL
- Adequate kidney function: serum creatinine of ≤ 1.5mg/dl and/or creatinine clearance of ≥ 60 mL/min
- Adequate hepatic function: transaminases < 2 x upper limit of normal and total bilirubin ≤ 1.5 mg/dL.
- Must have a serum albumin ≥ 3.0 g/dL.
- Must be informed of investigational nature of study and must sign informed consent in accordance with institutional rules.
- Pretreatment lab values must be performed within 14 days of patient registration and other baseline studies within 30 days.
- Patients will have a baseline bone scan, Computerized Tomography (CT) chest, abdomen and pelvis or Positron Emission Tomography (PET)/CT.
- If previously treated brain metastasis and free of central nervous system (CNS) symptoms and > 3 months from treatment of brain metastasis are eligible
Who cannot join
- Prior HER-2 targeted therapy for metastatic disease
- Has uncontrolled brain metastasis or leptomeningeal disease
- Has rapidly progressing and/or bulky disease which in the opinion of the investigator may be more appropriately treated with a chemotherapy-based strategy.
- Has an uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring parenteral antibiotics or psychiatric illness/social situations that would limit compliance with study requirements.
- Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors
- 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 (eg, Crohn's, ulcerative colitis).
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- Current active hepatic or biliary disease (exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- Renal function as measured by creatinine clearance <3 0ml/min (ratio to norm < 0.1)
- HIV-positive patients receiving combination antiretroviral therapy
- Pregnant women
- Active cardiac disease defined as:
- History of uncontrolled or symptomatic angina
- History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
- Myocardial infarction < 6 months from study entry
- Uncontrolled or symptomatic congestive heart failure
- Ejection fraction below institutional normal limit
- Any other cardiac condition, which in the opinion of treating physician, would make this protocol unreasonably hazardous for the patient
- History of another primary cancer, with exception of:
- curatively resected nonmelanomatous skin cancer
- curatively treated cervical carcinoma in-situ
- other primary solid tumor curatively resected treated with no known active disease present and no treatment administered for the last 3 years.
- Life expectancy of < 2 months
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Kansas Medical Center
Kansas City, Kansas, 66160
Truman Medical Center
Kansas City, Missouri, 64108
Cotton-O-Neil Cancer Center (Stormont Vail Health Care)
Topeka, Kansas, 66606
About this study
Official title: Phase II Trial of Lapatinib in Women With Hormone Receptor Positive (Estrogen Receptor [ER] and/or Progesterone Receptor [PR] +) Human Epidermal Growth Factor Receptor 2 (HER-2) Negative Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy
Hormone receptor positive breast cancer is the most common type of breast cancer, comprising 70-80% of all breast cancers. Endocrine therapy is the main type of initial treatment for patients with your type of breast cancer. Endocrine therapy is treatment that tries to remove, or block certain hormones from binding to the cancer cells and thus slow or stop the growth of cancer. Although most patients with your type of breast cancer respond initially to endocrine therapies, it can lose its effectiveness. New therapies for this type of cancer are needed.
Read the detailed description
Endocrine therapy forms the backbone of treatment for both early stage and advanced stage hormone receptor positive breast cancer. Although most patients with advanced estrogen receptor positive metastatic disease respond initially to endocrine therapies, this response is short lived. New therapies able to provide additional benefit to patients with hormone receptor positive, endocrine-resistant, advanced metastatic breast cancer are required. This study proposes to add lapatinib to endocrine therapy to treat hormone receptor positive HER-2 negative metastatic breast cancer patients.
- Conditions
- Metastatic Breast Cancer
- Being tested
- lapatinib
- Keywords
- breast cancer, hormone receptor positive, HER-2 negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lapatinibDrug
Also called Tykerb
lapatinib 1500 mg PO daily
| Study group | Role | What they receive |
|---|---|---|
| Lapatinib | Experimental | lapatinib Receives: Drug: lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
Progression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startMar 2009
- Primary completionNov 2015
- Study completion20 Aug 2018
Why it stopped: IRB decision
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 Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Kansas 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Priyanka Sharma, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759642
- Sponsor's protocol ID
- 11495
- Status last verified
- Jun 2019
- First submitted
- 24 Sep 2008
- Last updated
- 1 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Lapatinib in Women With Hormone Receptor Positive (Estrogen Receptor [ER] and/or Progesterone Receptor [PR] +) Human Epidermal Growth Factor Receptor 2 (HER-2) Negative Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy
- ClinicalTrials.gov ID
- NCT00759642
- Acronym / sponsor ID
- 11495
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, hormone receptor positive, HER-2 negative
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: IRB decision
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Nov 2015 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 25 Sep 2008 (estimated)
- Results
- Posted 23 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hormone receptor positive breast cancer is the most common type of breast cancer, comprising 70-80% of all breast cancers. Endocrine therapy is the main type of initial treatment for patients with your type of breast cancer. Endocrine therapy is treatment that tries to remove, or block certain hormones from binding to the cancer cells and thus slow or stop the growth of cancer. Although most patients with your type of breast cancer respond initially to endocrine therapies, it can lose its effectiveness. New therapies for this type of cancer are needed.
Detailed description
Endocrine therapy forms the backbone of treatment for both early stage and advanced stage hormone receptor positive breast cancer. Although most patients with advanced estrogen receptor positive metastatic disease respond initially to endocrine therapies, this response is short lived. New therapies able to provide additional benefit to patients with hormone receptor positive, endocrine-resistant, advanced metastatic breast cancer are required. This study proposes to add lapatinib to endocrine therapy to treat hormone receptor positive HER-2 negative metastatic breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lapatinib | Experimental | Drug: lapatiniblapatinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically or cytologically confirmed invasive breast cancer, which at time of study entry is either stage III (locally advanced) disease not amenable to curative therapy or stage IV disease. Histological confirmation of recurrent/metastatic disease is encouraged but not required if clinical evidence of stage IV disease recurrence is available.
- ER and/or Progesterone Receptor (PgR )positive breast cancer (10% or more of infiltrating cancer cells exhibit nuclear staining for ER and/or PgR)
- Have had progressive disease or development of new metastatic disease while on treatment or within 12 months of treatment with an aromatase inhibitor and/or Fulvestrant in adjuvant or metastatic setting
- Have measurable (defined as at least 1 lesion that can be accurately measured in at least 1 dimension [longest diameter to be recorded], with minimum lesion size ≥ 2cm on conventional measurement techniques or ≥ 1cm on spiral computed tomography [CT] scan), or evaluable disease. Patients with lytic or blastic bone disease as only site of disease will be eligible for the study. These patients will be evaluable for progression but not for response.
- Primary tumor was HER-2 negative (IHC 0 or IHC 1+/2+ and Fluorescence in situ hybridization [FISH] ≤ 1.9)
Key exclusion criteria (22 listed)
- Prior HER-2 targeted therapy for metastatic disease
- Has uncontrolled brain metastasis or leptomeningeal disease
- Has rapidly progressing and/or bulky disease which in the opinion of the investigator may be more appropriately treated with a chemotherapy-based strategy.
- Has an uncontrolled intercurrent illness including, but not limited to ongoing or active infection requiring parenteral antibiotics or psychiatric illness/social situations that would limit compliance with study requirements.
- Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors
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: Tykerblapatinib 1500 mg PO daily | Drug | Lapatinib |
Primary outcome
Progression Free Survival
Time frame: 12 months
Progression free survival (PFS) will be defined as the interval between the date of study initiation and the earliest date of disease progression, determined by tumor assessment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Priyanka Sharma, MD principal investigator
University of Kansas Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lapatinib in people with Metastatic Breast Cancer, run by University of Kansas Medical Center at 3 sites 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 18 inclusion and 22 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 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Yes. Results are posted in the registry (first posted 23 May 2017). 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?
Progression Free Survival (time frame: 12 months). 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 1 Jul 2019.