Clinical trial · Interventional
Fulvestrant or Tamoxifen in Treating Postmenopausal Women Who Are Undergoing Surgery for Ductal Carcinoma in Situ of the Breast
A Pilot Clinical Trial to Evaluate the Biological Activity of Fulvestrant (Faslodex) in Breast Ductal Carcinoma (DCIS)
- 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 fulvestrant or tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving fulvestrant or tamoxifen before surgery may be an effective treatment for breast cancer. PURPOSE: This randomized clinical trial is studying how well giving fulvestrant or tamoxifen works in treating postmenopausal women who are undergoing surgery for ductal carcinoma in situ of the breast.
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 |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| fulvestrant | Drug | Fulvestrant | ALIAS |
| neoadjuvant therapy | Procedure | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Molecular markers of the estrogen pathway as measured by immunohistochemistry at 3 weeks
Secondary outcomes (1)
- measure
- Mammographic breast density as measured by the Madena method at 3 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed ductal carcinoma in situ (DCIS) of the breast * T0 disease * Newly diagnosed disease by minimally invasive biopsy (e.g., a vacuum-assisted large core tool \[mammotome\] or an equivalent method) * Biopsy tissue available for molecular marker analysis * Baseline mammography performed within the past 8 weeks * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * Postmenopausal Sex * Female Menopausal status * Postmenopausal, as defined by 1 of the following: * Age ≥ 60 * Age ≥ 45 AND amenorrheic for \> 1 year with uterus intact * Underwent bilateral oophorectomy * Follicle-stimulating hormone and estradiol levels in postmenopausal range Performance status * SWOG 0-1 Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 8.0 g/dL Hepatic * SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Bilirubin ≤ 2.0 times ULN Renal * Creatinine ≤ 2.0 mg/dL Cardiovascular * No history of deep vein thrombosis Pulmonary * No history of pulmonary embolism Other * Negative pregnancy test (if clinically indicated) * No peripheral neuropathy \> grade 1 * No underlying medical, psychiatric, or social condition that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * More than 6 months since prior hormonal therapy, including any of the following: * Antiestrogens * Estrogen * Selective estrogen-receptor modulators * Progestins * Aromatase inhibitors Radiotherapy * Not specified Surgery * Not specified Other * No prior therapy for DCIS
References
Publications (0)
Data not yet available