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- Klinische proef NCT00759642
Lapatinib in Women With Metastatic Breast Cancer Who Have Failed Prior Antihormone Therapy
19 juni 2019 bijgewerkt door: University of Kansas Medical Center
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.
Studie Overzicht
Toestand
Beëindigd
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
33
Fase
- Fase 2
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Kansas
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Kansas City, Kansas, Verenigde Staten, 66160
- University of Kansas Medical Center
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Topeka, Kansas, Verenigde Staten, 66606
- Cotton-O-Neil Cancer Center (Stormont Vail Health Care)
-
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Missouri
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Kansas City, Missouri, Verenigde Staten, 64108
- Truman Medical Center
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-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Beschrijving
Inclusion Criteria
- 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
- 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
Exclusion Criteria
- 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).
- 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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: Lapatinib
lapatinib
|
lapatinib 1500 mg PO daily
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Progression Free Survival
Tijdsspanne: 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.
|
12 months
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Hoofdonderzoeker: Priyanka Sharma, MD, University of Kansas Medical Center
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2009
Primaire voltooiing (Werkelijk)
1 november 2015
Studie voltooiing (Werkelijk)
20 augustus 2018
Studieregistratiedata
Eerst ingediend
24 september 2008
Eerst ingediend dat voldeed aan de QC-criteria
24 september 2008
Eerst geplaatst (Schatting)
25 september 2008
Updates van studierecords
Laatste update geplaatst (Werkelijk)
1 juli 2019
Laatste update ingediend die voldeed aan QC-criteria
19 juni 2019
Laatst geverifieerd
1 juni 2019
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 11495
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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