Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Virginia Commonwealth University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01293032
First received: February 7, 2011
Last updated: April 29, 2014
Last verified: April 2014
  Purpose

RATIONALE: DNA analysis of tumor tissue may help doctors predict how well patients will respond to treatment and plan effective treatment.

PURPOSE: This phase II trial is studying how well hormone therapy or chemotherapy before surgery based on gene expression analysis works in treating patients with breast cancer


Condition Intervention
Ductal Breast Carcinoma in Situ
Lobular Breast Carcinoma in Situ
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Other: laboratory biomarker analysis
Other: enzyme-linked immunosorbent assay
Genetic: gene expression analysis
Drug: systemic chemotherapy
Drug: tamoxifen citrate
Drug: aromatase inhibition therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Choosing Neoadjuvant Chemotherapy Versus Hormonal Therapy for Breast Cancer Based on Gene Expression Profile

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Number of patients who refuse assigned therapy [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    If more than 1/3 of patients refuse assigned therapy, a larger study would either be deemed not feasible or would have to be designed with the assumption that this proportion of patients would refuse assigned treatment


Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GROUP I (RS < 11)
Patients receive neoadjuvant hormonal therapy comprising tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.
Procedure: neoadjuvant therapy
Undergo neoadjuvant therapy
Procedure: therapeutic conventional surgery
Undergo therapeutic conventional surgery
Other: laboratory biomarker analysis
Correlative studies
Other: enzyme-linked immunosorbent assay
Correlative studies
Other Name: ELISA
Genetic: gene expression analysis
Undergo Oncotype Dx gene expression profiling
Drug: tamoxifen citrate
Undergo hormonal therapy
Other Names:
  • Nolvadex
  • TAM
  • tamoxifen
  • TMX
Drug: aromatase inhibition therapy
Undergo hormonal therapy
Other Name: inhibition therapy, aromatase
Experimental: GROUP II ARM I (RS 11-25)
Patients receive neoadjuvant hormonal therapy as in group I.
Procedure: neoadjuvant therapy
Undergo neoadjuvant therapy
Procedure: therapeutic conventional surgery
Undergo therapeutic conventional surgery
Other: laboratory biomarker analysis
Correlative studies
Other: enzyme-linked immunosorbent assay
Correlative studies
Other Name: ELISA
Genetic: gene expression analysis
Undergo Oncotype Dx gene expression profiling
Drug: tamoxifen citrate
Undergo hormonal therapy
Other Names:
  • Nolvadex
  • TAM
  • tamoxifen
  • TMX
Drug: aromatase inhibition therapy
Undergo hormonal therapy
Other Name: inhibition therapy, aromatase
Experimental: GROUP II ARM II (RS 11-25)
Patients receive 6-8 courses of neoadjuvant chemotherapy comprising an anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.
Procedure: neoadjuvant therapy
Undergo neoadjuvant therapy
Procedure: therapeutic conventional surgery
Undergo therapeutic conventional surgery
Other: laboratory biomarker analysis
Correlative studies
Other: enzyme-linked immunosorbent assay
Correlative studies
Other Name: ELISA
Genetic: gene expression analysis
Undergo Oncotype Dx gene expression profiling
Drug: systemic chemotherapy
Undergo chemotherapy
Experimental: GROUP III (RS > 25)
Patients receive neoadjuvant chemotherapy as in arm II of group II.
Procedure: therapeutic conventional surgery
Undergo therapeutic conventional surgery
Other: laboratory biomarker analysis
Correlative studies
Other: enzyme-linked immunosorbent assay
Correlative studies
Other Name: ELISA
Genetic: gene expression analysis
Undergo Oncotype Dx gene expression profiling
Drug: systemic chemotherapy
Undergo chemotherapy

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • The treating surgeon must determine that breast conservation therapy (BCT) would be made more feasible by reducing tumor size using neoadjuvant systemic therapy - The patient must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines
  • The patient must be female
  • The patient must be greater than or equal to 18 years old
  • The patient must have an ECOG performance status of 0 or 1
  • The diagnosis of invasive carcinoma of the breast must have been made by core needle biopsy
  • The primary breast tumor must be >= 2 cm by physical exam or imaging
  • Ipsilateral axillary lymph nodes must be evaluated by imaging (MRI or ultrasound) within 6 weeks prior to randomization; If indicated for abnormal lymph nodes, fine needle aspirate (FNA) or core biopsy must be performed.
  • The tumor must have been determined to be HER2-negative as follows: fluorescent in situ hybridization (FISH)-negative (defined by ratio of HER2 to CEP17 must be < 2.2) or, if a ratio was not performed, the HER2 gene copy number must be < 4 per nucleus; or if CISH is performed, the result must indicate a HER2 gene copy number of < 6 per nucleus; or immunohistochemistry (IHC) 0-1+; or IHC 2+ and FISH-negative or CISH-negative
  • The tumor must have been determined to be ER+ and/or progesterone positive (PgR+) defined as > 10% tumor staining by immunohistochemistry
  • The patient must be considered by the treating medical oncologist to be medically able to tolerate standard cytotoxic chemotherapy regimens

Exclusion Criteria:

  • FNA alone to diagnose the primary tumor
  • Excisional biopsy or lumpectomy performed prior to randomization
  • Surgical axillary staging procedure or sentinel node (SN) biopsy performed prior to randomization
  • Tumors clinically staged as including inflammatory breast cancer
  • Ipsilateral cN2b or cN3 disease; (patients with cN1 or cN2a disease are eligible)
  • Definitive clinical or radiologic evidence of metastatic disease; (Note: chest imaging [mandatory for all patients] and other imaging [if required] must have been performed within 6 weeks prior to randomization)
  • Synchronous or metachronous contralateral invasive breast cancer; (patients with synchronous and/or metachronous contralateral DCIS or LCIS are eligible)
  • HER2 test result of IHC 3+, regardless of FISH results, if performed
  • Any history of ipsilateral invasive breast cancer or ipsilateral DCIS if treated with radiation therapy (RT); (patients with synchronous or metachronous ipsilateral LCIS are eligible)
  • History of non-breast malignancies, except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin, within 5 years prior to randomization
  • Treatment including RT, chemotherapy, and/or targeted therapy for the currently diagnosed breast cancer prior to randomization
  • Cardiac disease (history of and/or active disease) that would preclude the use of chemotherapy
  • Pregnancy or lactation at the time of randomization; (Note: pregnancy testing must be performed within 2 weeks prior to randomization for women of childbearing potential)
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
  • Use of any investigational product within 30 days prior to randomization
  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: NCT01293032

Contacts
Contact: Harry D. Bear, MD, PhD 804-828-9325 hdbear@vcu.edu
Contact: Cheryl Wood, RN 804-828-8459 cvwood@vcu.edu

Locations
United States, District of Columbia
Washington Cancer Institute Active, not recruiting
Washington, District of Columbia, United States, 20010
United States, North Carolina
Carolina Medical Center Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Richard White, MD    704-355-3809    richard.white@carolinashealthcare.org   
Contact: Amy Yeh, RN    704-355-1672    amy.yeh@carolinashealthcare.org   
Principal Investigator: Richard White, MD         
Forsyth Regional Cancer Center Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Judith Hopkins, MC    336-277-8887    JOH001@novanthealth.org   
Contact: Elizabeth White    336-718-8461    ecwhite@novanthealth.org   
Principal Investigator: Judith Hopkins, MD         
Cone Health Cancer Center Recruiting
Greensboro, North Carolina, United States, 27403
Contact: Peter Rubin, MD    336-832-1100    Peter.Rubin@conehealth.com   
Principal Investigator: Peter Rubin, MD         
United States, Texas
Methodist Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Angel Rodriguez, MD    713-441-0681    aarodriguez@tmhs.org   
Contact: Amber Froehlich    713-441-0685    afroehlich@tmhs.org   
Principal Investigator: Angel Rodriguez, MD         
United States, Virginia
University of Virginia Health System Not yet recruiting
Charlottesville, Virginia, United States, 22908
Contact: Christiana Brennin, MD    434-924-8552    cmb4z@virginia.edu   
Principal Investigator: Christiana Brennin, MD         
Lynchburg Hematology Oncology Clinic, Inc Recruiting
Lynchburg, Virginia, United States, 24501
Contact: John L. MacNeill, Jr., MD    434-200-5925    JLMacNeill@yahoo.com   
Contact: Donna Washburn, RN    434-200-1495    Donna.Washburn@centrahealth.com   
Principal Investigator: John MacNeill, MD         
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Harry D. Bear, MD, PhD    804-828-9325    hdbear@vcu.edu   
Contact: Cheryl Wood, RN    804-828-8459    cvwood@vcu.edu   
Principal Investigator: Harry D. Bear         
Canada, Quebec
Centre Hospitalier de l'Université de Montréal , Hôtel-Dieu Hospital Recruiting
Montreal, Quebec, Canada, H2W 1T8
Contact: André Robidoux, MD    514-890-8000 ext 14191    andre.robidoux.chum@ssss.gouv.qc.ca   
Principal Investigator: André Robidoux, MD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Harry D. Bear, MD, PhD Virginia Commonwealth University
  More Information

Additional Information:
No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01293032     History of Changes
Other Study ID Numbers: MCC-13311, NCI-2010-02342, P30CA016059
Study First Received: February 7, 2011
Last Updated: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
estrogen receptor-positive breast cancer
HER2-negative breast cancer
progesterone receptor-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Lobular
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Carcinoma, Ductal
Tamoxifen
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists

ClinicalTrials.gov processed this record on July 20, 2014