- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
California
-
Duarte, California, États-Unis, 91010-3000
- City of Hope Medical Center
-
South Pasadena, California, États-Unis, 91030
- South Pasadena Cancer Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
Études corrélatives
Autres noms:
Donné oralement
One year after completion of study treatment
One year after completion of study treatment
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression-free Survival
Délai: 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.
|
Until disease progression of death from any cause, up to 3 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Overall Response Rate
Délai: 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
|
Until disease progression or off treatment, assessed up to 1 year
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: George Somlo, MD, City of Hope Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies de la peau
- Tumeurs
- Tumeurs par site
- Maladies du sein
- Tumeurs mammaires
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Hormones, substituts hormonaux et antagonistes hormonaux
- Antagonistes hormonaux
- Inhibiteurs de l'aromatase
- Inhibiteurs de la synthèse des stéroïdes
- Antagonistes des œstrogènes
- Exémestane
Autres numéros d'identification d'étude
- 08063
- P30CA033572 (Subvention/contrat des NIH des États-Unis)
- CHNMC-08063
- CDR0000629864 (Identificateur de registre: NCI PDQ)
- NCI-2010-00761 (Identificateur de registre: NCI CTRP)
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Cancer du sein
-
AstraZenecaRecrutementAdv Solid Malig - H&N SCC, ATM Pro / Def NSCLC, Gastric, Breast and Ovarian CancerEspagne, États-Unis, Belgique, Royaume-Uni, France, Hongrie, Canada, Corée, République de, Australie
Essais cliniques sur méthode de coloration immunohistochimique
-
Icahn School of Medicine at Mount SinaiNational Institute of Mental Health (NIMH)ComplétéTroubles de l'alimentationÉtats-Unis
-
Istanbul UniversityComplétéDélire postopératoireTurquie
-
Centre Cardiologique du NordPas encore de recrutementDélire post-opératoire | Profondeur anesthésiqueFrance