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Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer

NCT00244933 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-06-22

Study results available
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Summary

RATIONALE: Drugs used in chemotherapy, such as gemcitabine hydrochloride and genistein, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gemcitabine hydrochloride together with genistein works in treating women with stage IV breast cancer.

Conditions

Interventions

DIETARY_SUPPLEMENT

genistein

Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.

DRUG

gemcitabine

Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days

PROCEDURE

Tumor biopsy

Biopsy of tumor prior to dose of genistein (Novasoy)

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Amy Weise, DO · Barbara Ann Karmanos Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-02-29
Primary Completion
2008-11-30
Completion
2009-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00244933 on ClinicalTrials.gov