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

NCT00010153 | Terminated Phase 3

• 2 other identifiers: EORTC-10963BIG-EORTC-10963
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

stage I breast cancer; stage II breast cancer

Interventions

fulvestrant DRUG

conventional surgery PROCEDURE

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead
• Breast International Group: collaborator

Study Sites (1)

Christie Hospital N.H.S. Trust

Manchester, England, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

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

  Leiden University Medical Center

  STUDY CHAIR

• Anthony Howell, MD

  The Christie NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2001
• First Posted: January 27, 2003
• Study Start: November 1, 2000
• Primary Completion: October 1, 2001
• Last Updated: July 19, 2012

Record last verified: 2012-07

Locations

GB (1)