Trial Using Docetaxel Cytoxan in Breast Cancers With High Recurrence Scores

This study is currently recruiting participants.
Verified November 2013 by Emory University
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Amelia Zelnak, Emory University
ClinicalTrials.gov Identifier:
NCT00832338
First received: January 29, 2009
Last updated: November 18, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Breast Neoplasms
Breast Cancer
Cancer of the Breast
Drug: Docetaxel and Cytoxan
Drug: Dexamethasone
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Response to pre-operative docetaxel and Cytoxan (TC) [ Time Frame: approximately 18 weeks ] [ Designated as safety issue: Yes ]

    Patients will be assessed for surgery after 6 cycles of TC (18 weeks).

    The primary method of response determination will be by clinical examination, but mammography, breast ultrasound and breast MRI can be used to confirm response or non-response at the discretion of the investigator.



Estimated Enrollment: 40
Study Start Date: April 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel with Cytoxan
Patients will be treated with docetaxel at 75mg/m2 concomitantly with cytoxan 600 mg/m2 (TC) IV D1 every 3 weeks for 6 cycles
Drug: Docetaxel and Cytoxan
Docetaxel 75mg/m2 plus cytoxan 600mg/m2 every 3 weeks for 6 cycles
Other Names:
  • Docetaxel
  • Cytoxan
Drug: Dexamethasone
Due to known toxicity of docetaxel, all patients require dexamethasone 4mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.

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. This consent form will describe these parts of the study later, in Addendums I and II.

  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).
  • 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 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 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 (28 days for x-rays and scans) immediately preceding patient's entry in study.

  • 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/mm.3
    • Hepatic function: Total bilirubin < upper limit of normal (ULN). SGOT(AST) or SGPT(ALT) and Alkaline Phosphatase ≤ 1.5 x ULN).
    • Renal function: Calculated CrCl > 30mL/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 CNS metastases.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00832338

Contacts
Contact: Amelia Zelnak, MD 1-88-946-7447 mbruce@emory.edu

Locations
United States, Georgia
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Principal Investigator: Ruth O'Regan, MD         
Sponsors and Collaborators
Emory University
Sanofi
Investigators
Principal Investigator: Amelia Zelnak, MD Emory University Winship Cancer Institute
  More Information

No publications provided

Responsible Party: Amelia Zelnak, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00832338     History of Changes
Other Study ID Numbers: IRB00012185, WCI1505-08
Study First Received: January 29, 2009
Last Updated: November 18, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Breast cancer
Tumors, Breast
Cancer of the breast

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Recurrence
Neoplasms by Site
Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes
Cyclophosphamide
Docetaxel
Dexamethasone
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014