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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01293032
First received: February 7, 2011
Last updated: February 1, 2015
Last verified: February 2015
  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
Primary Completion Date: November 2014 (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 institutional review board (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 Eastern Cooperative Oncology Group Score (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 Chromosome 17 centromere (CEP17) must be < 2.2) or, if a ratio was not performed, the HER2 gene copy number must be < 4 per nucleus; or if Cytokine-inducible SH2-containing protein (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 ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (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

Locations
United States, District of Columbia
Washington Cancer Institute
Washington, District of Columbia, United States, 20010
United States, North Carolina
Carolina Medical Center
Charlotte, North Carolina, United States, 28203
Forsyth Regional Cancer Center
Charlotte, North Carolina, United States, 28204
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
United States, Texas
Methodist Cancer Center
Houston, Texas, United States, 77030
United States, Virginia
Lynchburg Hematology Oncology Clinic, Inc
Lynchburg, Virginia, United States, 24501
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Canada, Quebec
Centre Hospitalier de l'Université de Montréal , Hôtel-Dieu Hospital
Montreal, Quebec, Canada, H2W 1T8
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: February 1, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Virginia Commonwealth University:
estrogen receptor-positive breast cancer
human epidermal growth factor receptor 2 (HER2)-negative breast cancer
progesterone receptor-positive breast cancer

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

ClinicalTrials.gov processed this record on March 30, 2015