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Exemestane or Docetaxel-Cytoxan in Low Recurrence Score Cancers

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Emory University
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Amelia Zelnak, Emory University
ClinicalTrials.gov Identifier:
NCT00941330
First received: July 15, 2009
Last updated: November 14, 2014
Last verified: November 2014
  Purpose

The patients are being asked to take part in this study because they have a hormone receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their doctor has told them that they have an option to receive chemotherapy or hormonal therapy before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor and allow them to preserve the breast or have less extensive surgery on their breast.


Condition Intervention Phase
Breast Cancer
Drug: Exemestane
Drug: Docetaxel, cytoxan
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) or Exemestane in Patients With Hormone Receptor-Positive Breast Cancers With Recurrence Scores Less Than 25 (≤ 24)

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Pathologic complete response. [ Time Frame: After surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical response rate, response rate by imaging, correlative studies [ Time Frame: Every 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 85
Study Start Date: July 2009
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
ARM A: Patients will be treated with exemestane.
Drug: Exemestane
25mg daily by mouth for 6 to 12 months
Other Names:
  • Exemestane
  • Aromasin
Active Comparator: B
ARM B: Patients will be treated with docetaxel and cytoxan.
Drug: Docetaxel, cytoxan
Docetaxel (75 mg/m2) and Cytoxan (600 mg/m2) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).
Other Names:
  • Docetaxel
  • Taxotere
  • Cytoxan
  • Cyclophosphamide

Detailed Description:

The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of your breast tumor and allow you to preserve your breast or have less extensive surgery on your breast. Additionally, by receiving chemotherapy or hormonal therapy before surgery, we will be able to determine if the treatment you receive is effective in treating your cancer. Prior to entering this study, a special test, called the Oncotype DX assay, will be performed on a small amount of your cancer from the biopsy you had at the time you were diagnosed with breast cancer, to determine the likelihood that your cancer will benefit from and shrink with chemotherapy and hormonal therapy. You will only be eligible to enter this study if the recurrence score of your cancer determined using the Oncotype DX assay is less than or equal to 24. Patients with hormone receptor-positive breast cancers with recurrence scores less than or equal to 24 have been previously demonstrated to obtain a larger benefit from hormonal therapy, compared to chemotherapy, when these agents are given after surgery. The ability of hormonal agents and chemotherapy to shrink cancers prior to surgery has not been specifically examined in hormone receptor-positive cancers with recurrence scores less than or equal to 24.

  Eligibility

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

Inclusion Criteria:

  • Signed informed consent.
  • Histologically or cytologically confirmed breast carcinoma.
  • Early stage breast cancer (T1c-3, cN0-3, CM0).
  • Pre-treatment biopsy with the following characteristics:

    • Hormone receptor-positive cancer as defined as ER and/or progesterone receptor (PR)-positive by standard immunohistochemistry (IHC)
    • HER2-negative (HER2 ≤ 2 by IHC; if HER2 2+ by IHC must be FISH non-amplified)
    • Recurrence score < 25 using Oncotype DX 21-gene recurrence score assay
  • Patients must have measurable disease as defined by palpable lesion with both diameters ≥ 1cm measurable with caliper or a positive mammogram or ultrasound with at least one dimension ≥ 1cm. Screening mammogram of the contralateral breast must be performed within past 12 months per standard practice guidelines. Clip placement is required for study entry.
  • Baseline measurements of the indicator lesions must be recorded on the Patient Registration Form. To be valid for baseline, the measurements must have been made within 14 days of study enrollment if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a diagnostic mammogram of the affected breast or MRI must be done within 2 months prior to study enrollment, defined as date of signed, informed consent. If clinically indicated, staging xrays and scans must be done within 28 days of study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • Adequate organ function within 14 days of study entry:

    • Bone marrow function: absolute neutrophil count (ANC) ≥ 1500/mm3, Hgb > 8.0 g/dl and platelet count ≥ 100,000/mm.3
    • Hepatic function: Total bilirubin < upper limit of normal (ULN). Serum glutamic oxaloacetic transaminase (SGOT) (AST) or serum glutamic pyruvic transaminase (SGPT) (ALT) and alkaline phosphatase ≤ 1.5 x ULN).
    • Renal function: Calculated creatinine clearance (CrCl) ≥ 30 mL/min using the Cockcroft Gault equation.
  • Patients must be at least 18 years of age.

Exclusion Criteria:

  • Evidence of disease outside the breast or chest wall, except ipsilateral axillary or internal mammary lymph nodes.
  • Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
  • Pregnant or lactating women are not eligible. Women of childbearing potential must have a negative serum pregnancy test completed within 7 days of study entry, and use an appropriate form of birth control throughout the trial period.
  • Medical, psychological or surgical condition which the investigator feels might compromise study participation.
  • Patients with history within the last 5 years of previous or current malignancy at other sites with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.
  • Evidence of peripheral or sensory neuropathy.
  • Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 are excluded from participation.
  • Serious, uncontrolled, concurrent infection(s).
  • Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months prior to study entry.
  • Major surgery within 28 days of study entry.
  • Evidence of central nervous system (CNS) metastases.
  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: NCT00941330

Contacts
Contact: Amelia Zelnak, MD 404-778-4824 amelia.zelnak@emory.edu

Locations
United States, Georgia
Emory University Hospital Midtown Recruiting
Atlanta, Georgia, United States, 30308
Contact: Regina Mosley    404-778-4824    rmosle3@emory.edu   
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Contact: Regina Mosley    404-778-4824    rmosle3@emory.edu   
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Regina Mosley    404-778-4824    rmosle3@emory.edu   
Sponsors and Collaborators
Emory University
Pfizer
Investigators
Principal Investigator: Amelia Zelnak, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Amelia Zelnak, MD, Emory University
ClinicalTrials.gov Identifier: NCT00941330     History of Changes
Other Study ID Numbers: IRB00012969, WCI1534-08
Study First Received: July 15, 2009
Last Updated: November 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Breast, Male
Breast, Female

Additional relevant MeSH terms:
Breast Neoplasms
Recurrence
Breast Diseases
Disease Attributes
Neoplasms
Neoplasms by Site
Pathologic Processes
Skin Diseases
Cyclophosphamide
Docetaxel
Exemestane
Alkylating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014