Clinical trial · Observational
Pharmacogenetics of Anastrozole in Postmenopausal Women With Estrogen Receptor-Positive and/or Progesterone Receptor-Positive Stage I, Stage II, or Stage III Breast Cancer
Pharmacogenetics of Aromatase Inhibitors
NCT00283608CI-TRIAL-00004844completedClinicalTrials.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: Studying samples of blood in the laboratory from patients with cancer receiving anastrozole may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors learn more about how anastrozole works in the body. PURPOSE: This research study is looking at the pharmacogenetics of anastrozole in postmenopausal women with estrogen receptor-positive (ER+) and/or progesterone receptor-positive (PR+) stage I, stage II, or stage III 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 |
|---|---|---|---|
| high performance liquid chromatography | Other | — | UNRESOLVED |
| measurements by DXA | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| Single nucleotide polymorphism (SNP) | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Anastrozole
- description
- Blood draws for baseline and six to twelve weeks.
- interventionNames
- Genetic: Single nucleotide polymorphism (SNP)
- Other: high performance liquid chromatography
- Other: measurements by DXA
- Other: questionnaire administration
- label
- Exemestane
- description
- Blood draws for baseline and six to twelve weeks
- interventionNames
- Genetic: Single nucleotide polymorphism (SNP)
- Other: high performance liquid chromatography
- Other: measurements by DXA
- Other: questionnaire administration
Primary outcomes (2)
- measure
- Association of single nucleotide polymorphisms with specific quantitative traits (i.e., hormone levels, breast density, and bone mineral density)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of breast cancer * Stage I, II, or III disease * Resected disease * Planning to undergo treatment with anastrozole at the clinically approved dose of 1 mg/day OR Mayo Clinic Cancer Center Rochester patient who will be enrolled on or has been enrolled on CAN-NCIC-MA27 and has not started taking the study medication (anastrozole or exemestane) * Hormone receptor status: * Estrogen receptor-positive and/or progesterone receptor-positive primary tumor PATIENT CHARACTERISTICS: * Female * Postmenopausal * Able to complete questionnaires alone or with assistance PRIOR CONCURRENT THERAPY: * More than 6 months since prior endocrine therapy, except tamoxifen * No other prior aromatase inhibitors (e.g., letrozole or exemestane) * No prior ovarian function suppression with surgery or radiotherapy, ovarian ablation, or luteinizing hormone-releasing hormone analogues (e.g., goserelin) as treatment for cancer
References
Publications (3)
- RESULTIngle JN, Buzdar AU, Schaid DJ, Goetz MP, Batzler A, Robson ME, Northfelt DW, Olson JE, Perez EA, Desta Z, Weintraub RA, Williard CV, Flockhart DA, Weinshilboum RM. Variation in anastrozole metabolism and pharmacodynamics in women with early breast cancer. Cancer Res. 2010 Apr 15;70(8):3278-86. doi: 10.1158/0008-5472.CAN-09-3024. Epub 2010 Mar 30. PMID 20354183
- DERIVEDLiu M, Goss PE, Ingle JN, Kubo M, Furukawa Y, Batzler A, Jenkins GD, Carlson EE, Nakamura Y, Schaid DJ, Chapman JA, Shepherd LE, Ellis MJ, Khosla S, Wang L, Weinshilboum RM. Aromatase inhibitor-associated bone fractures: a case-cohort GWAS and functional genomics. Mol Endocrinol. 2014 Oct;28(10):1740-51. doi: 10.1210/me.2014-1147. Epub 2014 Aug 22. PMID 25148458
- DERIVEDLiu M, Ingle JN, Fridley BL, Buzdar AU, Robson ME, Kubo M, Wang L, Batzler A, Jenkins GD, Pietrzak TL, Carlson EE, Goetz MP, Northfelt DW, Perez EA, Williard CV, Schaid DJ, Nakamura Y, Weinshilboum RM. TSPYL5 SNPs: association with plasma estradiol concentrations and aromatase expression. Mol Endocrinol. 2013 Apr;27(4):657-70. doi: 10.1210/me.2012-1397. Epub 2013 Mar 21. PMID 23518928