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Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00832338
Recruitment Status : Terminated (Funding withdrawn)
First Posted : January 30, 2009
Results First Posted : March 29, 2017
Last Update Posted : August 31, 2017
Information provided by (Responsible Party):
Elisavet Paplomata, Emory University

Brief Summary:
The purpose of this study is to assess if docetaxel and cytoxan 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 before surgery, the investigators will be able to determine if your cancer is responsive to chemotherapy.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Breast Cancer Cancer of the Breast Drug: Docetaxel with Cytoxan Drug: Dexamethasone Phase 2

Detailed Description:

Previous studies have shown that chemotherapy has the same effect on treating breast cancer whether you receive it before or after surgery. Receiving chemotherapy before surgery, rather than after surgery, may allow you to have less extensive surgery by shrinking the size of your cancer. The purpose of this study is to assess if docetaxel and cytoxan 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 before surgery, we will be able to determine if your cancer is responsive to chemotherapy. 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. You will only be eligible to enter this study if the recurrence score determined using the Oncotype DX assay is 25 or greater. Patients with hormone receptor-positive breast cancers with recurrence scores greater than or equal to 25 have been previously demonstrated to obtain a significant benefit from chemotherapy given after surgery.

In addition, researchers would like to examine proteins present in your blood and proteins present in your breast tissue. These additional parts of the study are voluntary and are NOT required to participate in this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) in Patients With Hormone Receptor-Positive Cancers With Recurrence Scores ≥ 25
Study Start Date : April 2009
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Docetaxel with Cytoxan
Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg twice daily (BID) PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.
Drug: Docetaxel with Cytoxan
Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.
Other Names:
  • Docetaxel
  • Cytoxan

Drug: Dexamethasone
Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel.
Other Name: Decadron

Primary Outcome Measures :
  1. Pathologic Response to Pre-operative Docetaxel and Cytoxan (TC) [ Time Frame: At time of definitive surgery ]

    Patients were assessed for surgery after 6 cycles of TC (18 weeks). Pathologic stage was determined based on size of tumor and degree of lymph node involvement at the time of surgery, whereas clinical stage pre-operatively was determined by clinical assessment and imaging.

    If pathologic stage was the same as clinical stage, it was called stable; if it was higher, upstaged (worse outcome); if lower, downstaged (better outcome). Pathologic stage was determined by Emory board-certified pathologists.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Signed informed consent.
  • Histologically or cytologically confirmed breast carcinoma.
  • Early stage breast cancer (T1c-3, clinically node-negative-3 [cN0-3], cM0).
  • No evidence of disease outside the breast or chest wall, except ipsilateral axillary or internal mammary lymph nodes.
  • 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 fluorescence in situ hybridization [FISH] non-amplified)
    • Recurrence score ≥ 25 using Oncotype DX 21-gene 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. 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 the 14 days if palpable. If not palpable, a mammogram or MRI must be done within 14 days. If palpable, a mammogram or MRI must be done within 2 months prior to study entry. If clinically indicated, xrays and scans must be done within 28 days of study entry.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
  • No prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
  • 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/mm³.
    • 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 Cockroft Gault equation.
  • Patients must be at least 18 years of age.

Exclusion Criteria:

  • 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.
  • No medical, psychological or surgical condition which the investigator feels might compromise study participation.
  • No 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.
  • No 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.
  • No serious, uncontrolled, concurrent infection(s).
  • No 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.
  • No major surgery within 28 days of study entry.
  • No evidence of central nervous system (CNS) metastases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00832338

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United States, Georgia
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
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Principal Investigator: Elisavet Paplomata, MD Emory University Winship Cancer Institute
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Responsible Party: Elisavet Paplomata, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00832338    
Other Study ID Numbers: IRB00012185
WCI1505-08 ( Other Identifier: Other )
First Posted: January 30, 2009    Key Record Dates
Results First Posted: March 29, 2017
Last Update Posted: August 31, 2017
Last Verified: August 2017
Keywords provided by Elisavet Paplomata, Emory University:
Breast cancer
Tumors, Breast
Cancer of the breast
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Antineoplastic Agents, Alkylating