- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00244959
Anastrozole in Treating Postmenopausal Women With DCIS or Stage I-III Breast Cancer
Surrogate Markers of Response: A Phase II Study of Changes in Breast Density Among Postmenopausal Women Receiving Adjuvant Anastrozole Therapy
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using anastrozole may fight breast cancer by lowering the amount of estrogen the body makes.
PURPOSE: This phase II trial is studying how anastrozole effects postmenopausal women who have undergone surgery for ductal carcinoma in situ or stage I, stage II, or stage III breast cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
Primary
- Determine the 12-month change in breast density in postmenopausal women with ductal carcinoma in situ (DCIS) or stage I-III breast cancer treated with adjuvant anastrozole.
Secondary
- Determine the change in estrone sulfate levels in patients treated with this drug.
- Correlate the change in breast density with the change in circulating estrone sulfate levels in patients treated with this drug.
- Determine the frequency of polymorphisms in aromatase (CYP19) and evaluate the relationship between wild-type aromatase enzyme with change in breast density and change in estrone sulfate levels in patients treated with this drug.
- Determine the 12-month change in bone density, and correlate it with the change in circulating estrone sulfate levels in patients treated with this drug.
- Correlate the reversal of hypermethylation with change in circulating estrone sulfate levels and breast density in patients treated with this drug.
OUTLINE: This is a pilot study. Patients are stratified according to concurrent bisphosphonate use (yes vs no).
Patients receive oral anastrozole once daily for up to 12 months in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Maryland
-
Baltimore, Maryland, États-Unis, 21231-2410
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer meeting 1 of the following criteria:
- Ductal carcinoma in situ (DCIS)
Invasive carcinoma
- Stage I-III disease
Must have undergone breast cancer surgery within the past 6 months, including any of the following:
- Mastectomy or lumpectomy with or without radiation
- Sentinel node and/or axillary node dissection
- Re-excision of lumpectomy margins
Intact contralateral breast
- No prior radiation therapy or mastectomy
- Prior biopsies allowed
Hormone receptor status:
- Estrogen and/or progesterone receptor-positive tumor by immunohistochemical staining
PATIENT CHARACTERISTICS:
Sex
- Female
Menopausal status
Postmenopausal, defined as 1 of the following:
- At least 60 years of age
- Less than 60 years of age and amenorrheic ≥ 12 months prior to study entry
- Less than 60 years of age, amenorrheic for < 12 months prior to day 1, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range
- Less than 60 years of age, without a uterus, and LH and FSH values within postmenopausal range
- Underwent prior bilateral oophorectomy
- Underwent prior radiation castration AND amenorrheic for ≥ 6 months
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Chemotherapy
- No prior or concurrent adjuvant chemotherapy for breast cancer
Endocrine therapy
- No prior aromatase inhibitor
- At least 6 weeks since prior and no concurrent tamoxifen
At least 6 weeks since prior and no concurrent hormone replacement therapy
- Concurrent low-dose, local vaginal estrogen in the form of either a conjugated estrogen ring or other similar product (e.g., Estring® or Vagifem®) allowed
- At least 6 weeks since prior and no other concurrent selective estrogen receptor modulators (e.g., raloxifene)
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
- No contralateral breast implant
Other
- Concurrent bisphosphonates allowed at the discretion of the treating oncologist
No concurrent consumption of soy supplements
- Concurrent routine dietary consumption of soy-containing foods allowed
- No other concurrent investigational or commercial drugs or therapies for the treatment of DCIS or invasive breast cancer
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: Anastrozole
Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer
|
1 mg orally daily for 12 months
Autres noms:
treatment received after breast cancer surgery
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
Change in breast density after 12 months of treatment
Délai: 12 months
|
12 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Change in hormone levels after 12 months of treatment
Délai: 12 months
|
12 months
|
Comparison between change in breast density with change in hormone levels after 12 months of treatment
Délai: 12 months
|
12 months
|
Comparison between the frequency of aromatase polymorphisms with changes in breast density and hormone levels after 12 months of treatment
Délai: 12 months
|
12 months
|
Comparison between change in bone density with change in hormone levels after 12 months of treatment
Délai: 12 months
|
12 months
|
Comparison between tissue methylation with changes in breast density and hormone levels after 12 months of treatment
Délai: 12 months
|
12 months
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chaise d'étude: Vered Stearns, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Publications et liens utiles
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 (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
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
- Agents antinéoplasiques, hormonaux
- Antagonistes hormonaux
- Inhibiteurs de l'aromatase
- Inhibiteurs de la synthèse des stéroïdes
- Antagonistes des œstrogènes
- Anastrozole
Autres numéros d'identification d'étude
- J0365 CDR0000446285
- P30CA006973 (Subvention/contrat des NIH des États-Unis)
- JHOC-J0365 (Autre identifiant: SKCCC at Johns Hopkins)
- JHOC-SKCCC-J0365 (Autre identifiant: SKCCC at Johns Hopkins)
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 .
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