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


Phase 3
N/A
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Cornelis J.H. van de Velde, MD, PhD, FRCS, FRCPS

Investigator Role:

Study Chair

Investigator Affiliation:

Leiden University Medical Center

Authority:

United States: Federal Government

Study ID:

EORTC-10963

NCT ID:

NCT00010153

Start Date:

November 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • Breast Neoplasms

Name

Location