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- Klinische proef NCT00810797
Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer
Intermittent Exemestane Therapy for Metastatic Breast Cancer
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how well exemestane works in treating postmenopausal women with stage IV breast cancer.
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. Progression-free survival at 4 months, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).
SECONDARY OBJECTIVES:
I. Objective response rate (complete response [CR] and partial response [PR]).
II. Clinical benefit (CR, PR, and stable disease >= 6 months).
III. Assessment of toxicity.
IV. Assessment of compliance with medication adherence.
V. Assessment of quality of life.
VI. Assessment of bone health.
TERTIARY OBJECTIVES:
I. Serial measurements of serum estradiol, estrone, and estrone sulfate.
II. To investigate treatment resistance (e.g., expression of amphiregulin, epidermal growth factor receptor [EGFR]), using molecular and immunohistochemical analyses of blood and tumor samples of pre- and post- (when available) treatment tissues. Microarray analyses to quantitate the expression of specific estrogen-responsive genes (e.g. thyroid transcription factor 1 [TTF1] and PDZK1) will also be performed.
OUTLINE: Patients receive exemestane orally (PO) once daily (QD) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for 1 year.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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California
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Duarte, California, Verenigde Staten, 91010-3000
- City of Hope Medical Center
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South Pasadena, California, Verenigde Staten, 91030
- South Pasadena Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Histologically or cytologically confirmed metastatic carcinoma of the breast
- Hormone receptor (estrogen receptor [ER] and/or progesterone receptor [PR]) positive disease (defined as: ER and/or PR positivity as >= 5% staining), as confirmed by immunohistochemistry (IHC) based on primary breast tissue or metastatic tissue
- Postmenopausal, as defined by any of the following:
- Natural menopause, with at least 1 year since last menses
- Chemotherapy-induced menopause with at least 1 year from last menses and serum luteinizing hormone (LH)/follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range
- History of surgical or radiation-induced ovarian ablation
- For women =< 56 years old and with a history of hysterectomy but at least one ovary intact, serum LH/FSH and estradiol levels must be within the postmenopausal range
- Postmenopausal women with disease recurrence while receiving either tamoxifen or a non-steroidal aromatase inhibitor (AI) as adjuvant therapy (as long as adjuvant hormonal therapy was taken for 6 months before disease progression) or with disease recurrence following the discontinuation/completion of adjuvant hormonal therapy
- Postmenopausal women with disease progression following either 0, 1 or 2 prior hormonal therapies for metastatic breast cancer, as long as the subject has had no prior exposure to exemestane (EXE)
- Measurable or non-measurable (but evaluable) disease, as defined by RECIST criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Neutrophil count >= 1.5 X 10^9 cells/L
- Platelet count >= 100 X 10^9 cells/L
- Serum creatinine =< 1.5 times upper limit of normal (ULN)
- Total serum bilirubin =< 1.5 times ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels =< 2.5 x ULN in patients without liver metastases or =< 5 times ULN in patients with liver metastases
- Alkaline phosphatase =< 2.5 times the ULN for patients without bone or liver metastases
- Subjects must have an estimated life expectancy of greater than 6 months
Exclusion Criteria:
- Prior exposure to EXE, whether in the adjuvant or metastatic setting
- Prior history of any other cancer with the exception of non-melanoma skin cancer and treated in situ carcinoma of the cervix
- Active or symptomatic central nervous system (CNS) metastasis (stable or treated brain metastasis allowed but patients must be off decadron, if given for CNS disease)
- Hormone-receptor negative or unknown breast cancer
- More than two prior chemotherapy regimen for treatment of metastatic disease (any prior chemotherapy given in the adjuvant setting is permitted)
- Administration of any other anti-cancer therapy within 2 weeks of initiating study treatment; use of bisphosphonates, however, are permitted for patients with known bone metastases
- Treatment with any other concurrent investigational agent or anti-tumor drug (chemotherapy, antibody therapy or other biologic agents), will not be permitted
- Subjects who have had no prior exposure to endocrine therapy
- Any uncontrolled medical co-morbidity or psychiatric disorder which interferes with the ability to provide informed consent or comply with study procedures
Studie plan
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: Treatment (exemestane)
Patients receive oral exemestane once daily on days 1-14.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
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Correlatieve studies
Andere namen:
Mondeling gegeven
One year after completion of study treatment
One year after completion of study treatment
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Progression-free Survival
Tijdsspanne: Until disease progression of death from any cause, up to 3 years
|
Estimated using the product-limit method of Kaplan and Meier.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
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Until disease progression of death from any cause, up to 3 years
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Overall Response Rate
Tijdsspanne: Until disease progression or off treatment, assessed up to 1 year
|
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
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Until disease progression or off treatment, assessed up to 1 year
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: George Somlo, MD, City of Hope Medical Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Huidziektes
- Neoplasmata
- Neoplasmata per site
- Borst ziekten
- Borstneoplasmata
- Fysiologische effecten van medicijnen
- Moleculaire mechanismen van farmacologische werking
- Enzymremmers
- Antineoplastische middelen
- Hormonen, hormoonvervangers en hormoonantagonisten
- Hormoon antagonisten
- Aromatase-remmers
- Steroïde syntheseremmers
- Oestrogeen antagonisten
- Exemestaan
Andere studie-ID-nummers
- 08063
- P30CA033572 (Subsidie/contract van de Amerikaanse NIH)
- CHNMC-08063
- CDR0000629864 (Register-ID: NCI PDQ)
- NCI-2010-00761 (Register-ID: NCI CTRP)
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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