Hormone Therapy in Treating Women With Breast Cancer

NCT00003428 | Completed Phase 2

• 4 other identifiers: 98-038CDR0000066453LILLY-H4Z-MC-JWWD(a)NCI-G98-1451
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using arzoxifene hydrochloride may fight breast cancer by blocking the use of estrogen by the tumor cells. PURPOSE: This randomized phase II trial is comparing two different doses of arzoxifene hydrochloride to see how well it works in treating women with advanced or metastatic breast cancer.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Interventions

arzoxifene hydrochloride DRUG

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Histologically proven locally advanced or metastatic breast cancer and meeting one of the following criteria: No prior systemic therapy OR Relapsed more than 12 months after stopping adjuvant tamoxifen (tamoxifen- sensitive) OR Relapsed while receiving adjuvant tamoxifen for more than 12 months (tamoxifen-refractory) OR Disease progression while receiving tamoxifen as first-line treatment for metastatic breast cancer (tamoxifen-refractory) Evaluable or bidimensionally measurable disease No rapid disease progression requiring chemotherapy Brain metastases allowed if stable for at least 6 months after surgery or radiotherapy, with no increase in corticosteroids Hormone receptor status: Estrogen receptor positive AND/OR Progesterone receptor positive OR Unknown status allowed if over 50 years old PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: ECOG 0-1 Life expectancy: At least 24 weeks Hematopoietic: Granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9 g/dL, transfusion independent Hepatic: Bilirubin no greater than 1.5 times normal PT/PTT no greater than 1.25 times upper limit of normal (ULN) ALT/AST no greater than 2.5 times ULN Renal: Creatinine less than 1.5 times ULN Calcium no greater than 11 mg/dL No hypercalcemia Other: Not pregnant or nursing Fertile patients must use approved nonhormonal contraceptive during and for 3 months after study No known predisposition to thromboembolic disorder At least 5 years since other primary malignancy except: Adequately treated nonmelanomatous skin cancer Carcinoma in situ of the cervix No serious concurrent systemic disorders incompatible with study PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Concurrent hematopoietic growth factor allowed Chemotherapy: No prior chemotherapy for metastatic breast cancer No concurrent chemotherapy Endocrine therapy: No prior hormonal therapy for metastatic breast cancer (except tamoxifen) No concurrent supplemental estrogen or progesterone At least 3 weeks since prior estrogen replacement therapy No other concurrent hormone therapy Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: Not specified Other: At least 4 weeks since prior use of other investigational agents Concurrent bisphosphonate therapy allowed No other concurrent investigational agent

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Clifford A. Hudis, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: September 13, 2004
• Study Start: May 1, 1998
• Primary Completion: June 1, 2001
• Study Completion: June 1, 2001
• Last Updated: June 24, 2013

Record last verified: 2013-06

Locations

US (1)