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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00010153

Enrollment

Unknown

Registered

2003-01-27

Start date

2000-11-30

Completion date

Unknown

Last updated

2012-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer

Brief summary

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.

Detailed description

OBJECTIVES: * Determine the inhibitory effect of ICI 182780 on the development of metastasis, as measured by disease-free survival and overall survival, in women with operable stage I or II primary breast cancer. * Determine toxicity of this regimen in these patients. OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and menopausal status (premenopausal vs postmenopausal). Patients are randomized to receive either ICI 182780 IM or placebo IM over 2 minutes on day 1. Patients undergo surgery between days 8 and 29. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 3,656 patients (1,828 per arm) will be accrued for this study within 2 years.

Interventions

DRUGfulvestrant

PROCEDUREconventional surgery

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Inclusion criteria

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026