Clinical trial · Interventional
Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer
Intermittent Exemestane Therapy for Metastatic Breast Cancer
NCT00810797CI-TRIAL-00047726completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exemestane | Drug | Exemestane | ALIAS |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (exemestane)
- description
- Patients receive oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: exemestane
- Other: laboratory biomarker analysis
- Procedure: quality-of-life assessment
- Other: immunohistochemistry staining method
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- Until disease progression of death from any cause, up to 3 years
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.