Clinical trial · Interventional
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
NCT00244959CI-TRIAL-00009764completedPhase 2ClinicalTrials.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 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.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| anastrozole | Drug | Anastrozole | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Anastrozole
- description
- Anastrozole (1mg, orally, daily) for 12 months as adjuvant therapy for breast cancer
- interventionNames
- Drug: anastrozole
- Procedure: adjuvant therapy
Primary outcomes (1)
- measure
- Change in breast density after 12 months of treatment
- timeFrame
- 12 months
Secondary outcomes (5)
- measure
- Change in hormone levels after 12 months of treatment
- timeFrame
- 12 months
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 cancerReferences
Publications (1)
- RESULTProwell TM, Blackford AL, Byrne C, Khouri NF, Dowsett M, Folkerd E, Tarpinian KS, Powers PP, Wright LA, Donehower MG, Jeter SC, Armstrong DK, Emens LA, Fetting JH, Wolff AC, Garrett-Mayer E, Skaar TC, Davidson NE, Stearns V. Changes in breast density and circulating estrogens in postmenopausal women receiving adjuvant anastrozole. Cancer Prev Res (Phila). 2011 Dec;4(12):1993-2001. doi: 10.1158/1940-6207.CAPR-11-0154. Epub 2011 Sep 1. PMID 21885816