Clinical trial · Interventional
ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer
A Double-Blind Phase III Clinical Trial to Compare the Effects of a Pre-Operatively Administered Single Dose of "Faslodex" (Long-Acting ICI 182.780) With Placebo on Tumor Recurrence in Pre- and Postmenopausal Women Treated for Operable First Primary Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases. PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary 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 |
|---|---|---|---|
| conventional surgery | Procedure | — | UNRESOLVED |
| fulvestrant | Drug | Fulvestrant | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed stage I or II primary operable breast cancer * Surgery planned within next 1-4 weeks * Hormone receptor status: * Estrogen receptor positive or unknown * No known estrogen receptor negative tumor * Unknown progesterone receptor status eligible PATIENT CHARACTERISTICS: Age: * Any age Sex: * Female Menopausal status: * Premenopausal or postmenopausal Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * No bleeding diathesis not compatible with an IM depot injection Hepatic: * Not specified Renal: * Not specified Other: * Not pregnant * Negative pregnancy test * Fertile patients must use effective non-hormonal contraception during and for 2-3 months after study * No other prior or concurrent malignancy except adequately treated basal cell carcinoma of the skin or cancer of the uterine cervix * No psychological, familial, sociological, or geographical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * At least 2 months since prior ICI 182780 Radiotherapy: * No prior radiotherapy to primary tumor Surgery: * See Disease Characteristics Other: * No other concurrent preoperative therapy for breast cancer
References
Publications (0)
Data not yet available