ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer

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Primary Purpose

Status

Terminated

Phase

Phase 3

Locations

United Kingdom

Study Type

Interventional

Intervention

fulvestrant

conventional surgery

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage I breast cancer, stage II breast cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Christie Hospital N.H.S. Trust

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00010153

First Posted

February 2, 2001

Last Updated

July 18, 2012

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Breast International Group

1. Study Identification

Unique Protocol Identification Number

NCT00010153

Brief Title

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

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Terminated

Why Stopped

low accrual

Study Start Date

November 2000 (undefined)

Primary Completion Date

October 2001 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Collaborators

Breast International Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

fulvestrant

Intervention Type

Procedure

Intervention Name(s)

conventional surgery

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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

Organizational Affiliation

Leiden University Medical Center

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Anthony Howell, MD

Organizational Affiliation

The Christie NHS Foundation Trust

Official's Role

Study Chair

Facility Information:

Facility Name

Christie Hospital N.H.S. Trust

City

Manchester

State/Province

England

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Breast Cancer

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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