Clinical trial · Interventional
Tamoxifen Compared With LY353381 in Treating Women With Newly Diagnosed Breast Cancer
A Phase IB Randomized Study of an Antiestrogen in Women With Newly Diagnosed Breast Cancer
NCT00005886CI-TRIAL-00025475completedPhase 1ClinicalTrials.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 stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen or LY353381 may fight breast cancer by blocking the use of estrogen. PURPOSE: This randomized phase I trial is studying how well tamoxifen works on the biomarkers of the tumor tissue, compared with LY353381, in treating women with newly diagnosed 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 |
|---|---|---|---|
| arzoxifene hydrochloride | Drug | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed noninvasive or small invasive breast cancer * Low or intermediate grade (ductal carcinoma in situ, T1, or T2) OR * Estrogen and/or progesterone receptor positive * Largest mass no greater than 5 cm * Clustered microcalcifications as only abnormality allowed with no upper size limit * If no distinction between mass and microcalcifications, size as 1 lesion * Lumpectomy or mastectomy must be planned for 2-6 weeks from start of study * No evidence of metastases from any malignancy * Hormone receptor status: * Estrogen and progesterone receptor positive (unless low or intermediate grade tumor) PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Postmenopausal by one of the following: * Prior oophorectomy * Over age 50 with prior hysterectomy, ovaries remaining * Uterus and ovaries intact and no menstrual period for more than 3 months Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 100,000/mm\^3 * Hemoglobin greater than 10 g/dL * Absolute granulocyte count greater than 1,000/mm\^3 Hepatic: * Albumin greater than 3 g/dL * Bilirubin less than 1.5 mg/dL * AST less than 100 U/L * Alkaline phosphatase less than 200 U/L Renal: * Creatinine less than 1.5 mg/dL Cardiovascular: * No history of deep vein thrombosis Pulmonary: * No prior pulmonary embolus Other: * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 1 year since prior chemotherapy Endocrine therapy: * At least 1 year since prior aromatase inhibitors, antiestrogens, or LH agonists/antagonists * No concurrent hormone replacement therapy or oral contraceptives (from time of randomization) Radiotherapy: * Not specified Surgery: * See Disease Characteristics Other: * No concurrent treatment for other malignancy
References
Publications (1)
- BACKGROUNDFabian CJ, Kimler BF, Anderson J, Tawfik OW, Mayo MS, Burak WE Jr, O'Shaughnessy JA, Albain KS, Hyams DM, Budd GT, Ganz PA, Sauter ER, Beenken SW, Grizzle WE, Fruehauf JP, Arneson DW, Bacus JW, Lagios MD, Johnson KA, Browne D. Breast cancer chemoprevention phase I evaluation of biomarker modulation by arzoxifene, a third generation selective estrogen receptor modulator. Clin Cancer Res. 2004 Aug 15;10(16):5403-17. doi: 10.1158/1078-0432.CCR-04-0171. PMID 15328178