Tamoxifen Citrate in Treating Premenopausal Women With Estrogen Receptor-Positive Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Roswell Park Cancer Institute
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01658566
First received: July 23, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

This randomized clinical trial studies tamoxifen citrate in treating premenopausal women with estrogen receptor (ER)-positive breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells


Condition Intervention
Estrogen Receptor-positive Breast Cancer
Stage I Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Drug: tamoxifen citrate
Genetic: polymerase chain reaction
Other: pharmacological study
Genetic: gene expression analysis
Other: immunohistochemistry staining method
Other: pharmacogenomic studies
Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry
Genetic: polymorphism analysis
Procedure: therapeutic conventional surgery
Genetic: nucleic acid sequencing
Genetic: protein analysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Comparisons of ERalpha-p53 interaction (positive or negative) between independent treatment and control groups [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The proportions of patients with positive ChIP assay will be compared with Fisher's Exact Test. Descriptive statistics such as frequencies and relative frequencies will be computed for all categorical variables. Numeric variables will be summarized using simple descriptive statistics such as mean, standard deviation, quartiles, etc. Ninety-five percent confidence intervals will be computed when appropriate.

  • Comparisons of mean messenger ribonucleic acid (mRNA) levels, as measured by quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR), across treatment and control groups [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The difference in log fold intensity between treatment and control will be estimated with an independent samples t-confidence interval. Descriptive statistics such as frequencies and relative frequencies will be computed for all categorical variables. Numeric variables will be summarized using simple descriptive statistics such as mean, standard deviation, quartiles, etc. Ninety-five percent confidence intervals will be computed when appropriate.


Estimated Enrollment: 50
Study Start Date: December 2007
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (standard of care)
Patients receive standard of care surgical therapy. Patients may undergo standard surgery.
Genetic: polymerase chain reaction
Correlative study
Other Name: PCR
Other: pharmacological study
Correlative study
Other Name: pharmacological studies
Genetic: gene expression analysis
Correlative study
Other: immunohistochemistry staining method
Correlative study
Other Name: immunohistochemistry
Other: pharmacogenomic studies
Correlative study
Other Name: Pharmacogenomic Study
Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry
Correlative study
Other Name: MALDI-TOF Mass Spectrometry
Genetic: polymorphism analysis
Correlative study
Procedure: therapeutic conventional surgery
Correlative study
Genetic: nucleic acid sequencing
Correlative study
Other Names:
  • Gene Sequencing
  • Molecular Biology, Nucleic Acid Sequencing
Genetic: protein analysis
Correlative study
Experimental: Arm II (tamoxifen citrate)
Patients receive tamoxifen PO daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may then undergo standard surgery.
Drug: tamoxifen citrate
Given PO
Other Names:
  • Nolvadex
  • TAM
  • tamoxifen
  • TMX
Genetic: polymerase chain reaction
Correlative study
Other Name: PCR
Other: pharmacological study
Correlative study
Other Name: pharmacological studies
Genetic: gene expression analysis
Correlative study
Other: immunohistochemistry staining method
Correlative study
Other Name: immunohistochemistry
Other: pharmacogenomic studies
Correlative study
Other Name: Pharmacogenomic Study
Other: matrix-assisted laser desorption/ionization time of flight mass spectrometry
Correlative study
Other Name: MALDI-TOF Mass Spectrometry
Genetic: polymorphism analysis
Correlative study
Procedure: therapeutic conventional surgery
Correlative study
Genetic: nucleic acid sequencing
Correlative study
Other Names:
  • Gene Sequencing
  • Molecular Biology, Nucleic Acid Sequencing
Genetic: protein analysis
Correlative study

Detailed Description:

PRIMARY OBJECTIVES:

I. Investigate the status of ERalpha-p53 interaction in ERalpha-positive, p53-wild type breast tumors in untreated patients and examine how tamoxifen (tamoxifen citrate) therapy modifies this interaction.

II. To confirm the wild type status of p53 and analyze the functional status of p53 pathway by monitoring expression of selected p53-target genes in tumors in patients who have or have not been treated with tamoxifen.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive standard of care surgical therapy. Patients may undergo standard surgery.

Arm II: Patients receive tamoxifen citrate orally (PO) daily for 4 weeks in the absence of disease progression or unacceptable toxicity. Patients may then undergo standard surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines
  • Core biopsy should definitively demonstrate invasive carcinoma
  • Invasive carcinoma should be ERalpha receptor positive
  • The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound); we recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible
  • Patients in whom surgical excision of the tumor is part of standard of care management
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Negative serum or urine beta-human chorionic gonadotropin (hCG) pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)
  • Consent to participate in Data Bank and BioRepository (DBBR)

Exclusion Criteria:

  • Male patients are not eligible for this study
  • Female patients with inoperable tumors or women with stage 4 disease diagnosed on computed tomography (CT), positron emission tomography (PET), PET/CT or bone scan
  • Patients with diagnosis by fine needle aspiration (FNA) cytology only
  • Pregnant or lactating women
  • Prior therapy for breast cancer, including irradiation, chemo-, immuno- and/or hormonal therapy
  • Patients receiving any hormonal therapy, e.g.,ovarian hormonal replacement therapy, infertility medications etc., are not eligible
  • Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient from being subjected to surgical excision
  • Psychiatric or addictive disorders that would preclude obtaining informed consent
  • Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, transient ischemic attack (TIA), or pulmonary embolism
  • Women with non-invasive disease or microinvasion are not eligible
  • Women undergoing neoadjuvant chemotherapy are not eligible
  • Women currently on tamoxifen for prevention are not eligible
  • Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh
  • Patients with a known mutation in p53 (Li Fraumer/ Syndrome)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01658566

Locations
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Swati Kulkarni, MD    773-702-2028      
Principal Investigator: Swati Kulkarni, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Roswell Park       ASKRPCI@Roswellpark.org   
Principal Investigator: Shicah Kumar, MD         
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Shicha Kumar, MD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01658566     History of Changes
Other Study ID Numbers: I 110907, NCI-2009-01760, R21CA137635
Study First Received: July 23, 2012
Last Updated: July 14, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Citric Acid
Tamoxifen
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 28, 2014