Clinical trial NCT00010153: ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: stage I breast cancer
stage II breast cancer
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: Breast International Group
First posted: 2003-01-27
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Christie Hospital N.H.S. Trust
state: England
Study officials:
affiliation: Leiden University Medical Center
name: Cornelis J.H. van de Velde, MD, PhD, FRCS, FRCPS
role: STUDY_CHAIR
affiliation: The Christie NHS Foundation Trust
name: Anthony Howell, MD
role: STUDY_CHAIR
References: