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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Amy Weise, Barbara Ann Karmanos Cancer Institute Identifier:
First received: October 25, 2005
Last updated: February 5, 2015
Last verified: February 2015

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.

Condition Intervention Phase
Breast Cancer
Dietary Supplement: genistein
Drug: gemcitabine
Procedure: Tumor biopsy
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays

Resource links provided by NLM:

Further study details as provided by Amy Weise, Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Objective Response Rate by RECIST Criteria Following [ Time Frame: every 2 courses until disease progression or death, up to 24 weeks ]
    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary Outcome Measures:
  • Duration of Response [ Time Frame: From the time the last patient comes off study treatment for one year ]
  • Overall Survival [ Time Frame: From the time the last patient comes off study treatment for one year to monitor survival ]
  • Time to Disease Progression [ Time Frame: From the time that treatment is initiated until the time restaging indicates progressive disease. ]
  • Duration of Survival [ Time Frame: At 1 year following study treatment ]
  • Qualitative and Quantitative Toxicities [ Time Frame: 30 days following treatment ]
  • Correlate Responses With Plasma Genistein Levels [ Time Frame: At course 1 day -7, course 1 day -1 (before and 4 hours after dose), course 2 day 1 (before and 4 hours after dose) ]
  • In Vivo Effects of Genistein in Breast Cancer Tissue Biomarkers (Ki67, TUNEL Assay, p-Akt, NF-kB, Immunohistochemistry and cDNA Microarray Analysis) [ Time Frame: At baseline (pre-genistein treatment) and 7 days following genistein treatment ]

Enrollment: 19
Study Start Date: February 2004
Study Completion Date: October 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcitabine, genistein (Novasoy), Tumor biopsy
Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
Dietary Supplement: genistein
Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
Other Name: Novasoy
Drug: gemcitabine
Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days
Other Names:
  • Gemcitabine hydrochloride
  • Gemzar®
Procedure: Tumor biopsy
Biopsy of tumor prior to dose of genistein (Novasoy)

Detailed Description:



  • Determine the objective response rate in patients with stage IV breast cancer treated with gemcitabine hydrochloride and genistein.


  • Determine the duration of response and survival of patients treated with this regimen.
  • Determine the time to disease progression in patients treated with this regimen.
  • Determine the quantitative and qualitative toxic effects of this regimen in these patients.
  • Correlate plasma genistein levels with response in patients treated with this regimen.

OUTLINE: Patients receive oral genistein once daily on days -7 to 1. Patients also receive gemcitabine hydrochloride IV on days 1 and 8 and oral genistein once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed breast cancer

    • Stage IV disease
    • Clinical and/or radiological evidence of metastatic disease
  • Measurable disease

    • Prior radiotherapy allowed provided there is ≥ 1 measurable disease site outside the radiation field
  • No active CNS metastases

    • Previously treated CNS metastases allowed provided disease is stable for ≥ 3 months without steroids or antiseizure medications
  • Hormone receptor status:

    • Not specified



  • Female

Menopausal status

  • Not specified

Performance status

  • SWOG 0-2

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL


  • Bilirubin ≤3.0 mg/dL
  • AST and ALT ≤ 2.5 times upper limit of normal


  • Creatinine ≤ 1.5 mg/dL


  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No serious systemic disorder that would preclude study compliance
  • No history of another malignancy except curatively treated carcinoma of the cervix or basal cell or squamous cell skin cancer in complete remission
  • No unresolved bacterial infection requiring antibiotic treatment
  • No known HIV-1 positivity


Biologic therapy

  • At least 3 weeks since prior biologic therapy


  • Prior adjuvant chemotherapy allowed
  • Prior adjuvant or neoadjuvant taxane-based therapy or taxane therapy for metastatic disease allowed

    • Patient must have failed therapy within 2 years after completion of treatment
  • At least 3 weeks since prior chemotherapy
  • No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease
  • No prior gemcitabine hydrochloride
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • At least 2 weeks since prior and no concurrent hormonal therapy

    • Must have documented disease progression during prior hormonal therapy


  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy and recovered
  • No concurrent radiotherapy


  • At least 3 weeks since prior surgery


  • At least 3 weeks since prior investigational therapy
  • At least 1 week since prior soy supplements (e.g., soy-based pills, liquids, or concentrates)

    • Dietary soy as part of a meal (e.g., tofu) allowed once a week
  • No concurrent nutritional supplements, herbal agents, or high doses of antioxidants (e.g., vitamins C, D, or E) that may interact with, antagonize, alter, or imitate the potential effects of gemcitabine hydrochloride or genistein

    • A single daily multivitamin is allowed
  • No other concurrent immunotherapy
  • No other concurrent experimental medication
  • Concurrent anticoagulants, appetite stimulants, and replacement steroids allowed
  Contacts and Locations
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Please refer to this study by its identifier: NCT00244933

United States, Michigan
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Principal Investigator: Amy Weise, DO Barbara Ann Karmanos Cancer Institute
  More Information

Responsible Party: Amy Weise, Principal Investigator, Barbara Ann Karmanos Cancer Institute Identifier: NCT00244933     History of Changes
Other Study ID Numbers: CDR0000446089
P30CA022453 ( US NIH Grant/Contract Award Number )
WSU-C-2597 ( Other Identifier: Barbara Ann Karmanos Cancer Institute )
Study First Received: October 25, 2005
Results First Received: January 12, 2015
Last Updated: February 5, 2015

Keywords provided by Amy Weise, Barbara Ann Karmanos Cancer Institute:
stage IV breast cancer
recurrent breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anticarcinogenic Agents
Protective Agents
Protein Kinase Inhibitors
Estrogens, Non-Steroidal
Hormones, Hormone Substitutes, and Hormone Antagonists processed this record on May 25, 2017