Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12

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. Identifier: NCT00194753
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : September 13, 2012
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Washington

Brief Summary:
The primary objectives of the study are to evaluate the feasibility and toxicity of treatment with 12 weeks of Adriamycin with daily oral Cytoxan with G-CSF support followed by 12 weeks of Taxol. Feasibility will be assessed by comparing the delivered dose intensity of each drug to the delivered dose intensity in previous trials. Toxicity will be assessed by comparing the incidence and severity of toxicity with these drugs to previous trials using these drugs in the same combination. We hypothesize metronomic, dose dense treatment as given in this study will be less toxic and more effective than historical regimens using the same drugs in a less metronomic, dose dense manner.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Drug: Paclitaxel Drug: Doxorubicin Drug: Cyclophosphamide Drug: G-CSF Phase 2

Detailed Description:
The systemic cancer treatments used in this study (Adriamycin, Cytoxan and Taxol) are all delivered in a dose dense, metronomic manner (weekly or daily). It is our hypothesis that dose dense treatment will result in optimum delivered dose intensity while minimizing toxicity. We will test these hypotheses by comparing the delivered dose intensity of the drugs to the delivered dose intensity of standard regimens. We will also compare time to relapse, survival and toxicity of this treatment to historic, standard regimens.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adjuvant Therapy for High-Risk Localized Breast Cancer With Weekly Adriamycin +/- Oral Cytoxan With Continuous G-CSF Support for 12 Weeks Followed by Weekly Taxol for 12 Weeks, Phase II
Study Start Date : December 2001
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Weekly doxorubicin (24 mg/m2 IV) with daily oral cyclophosphamide (60 mg/m2 PO) for 12 weeks with G-CSF support days 2 - 7 of each week followed by weekly paclitaxel (80 mg/m2 IV) for 12 weeks.
Drug: Paclitaxel
80 mg/m2 IV for 12 weeks following completion of doxorubicin and cyclophosphamide
Drug: Doxorubicin
24 mg/m2 IV weekly x 12
Drug: Cyclophosphamide
60 mg/m2 PO daily for 12 weeks
Drug: G-CSF
5 mcg per kg subcutaneously days 2 - 7 during doxorubicin and cyclophosphamide for 12 weeks

Primary Outcome Measures :
  1. Delivered dose intensity [ Time Frame: 24 weeks ]
  2. Toxicity [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Time to treatment failure [ Time Frame: 7 years ]
  2. Overall survival [ Time Frame: 7 years ]

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

Inclusion Criteria:

  • Patient must have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected. (This regimen is not intended for neoadjuvant treatment.)
  • The attending physician must judge the patient to be an appropriate candidate for Adriamycin based adjuvant chemotherapy. Appropriate candidates generally include those with stage II or III breast cancer. The individual attending physician, however, should make the decision.
  • Tumor HER-2/neu expression must be determined prior to study enrollment. Assessment may be by fluorescence in situ hybridization (FISH) assay or by immunocytochemistry (ICC). If determination is "intermediate" by immunocytochemistry, FISH must be performed. Protocol therapy is determined by HER-2/neu result.
  • Patient must be at least 18.
  • The patient must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
  • Pre-study hematologic values required for entry onto trial are: WBC greater than= 4,000/mm3, ANC greater than= 1,500/mm3 and platelets greater than= 100,000/mm3.

Exclusion Criteria:

  • Patients with significant renal dysfunction (creatinine greater than 1.5 x institutional upper limit of normal (IULN)) or hepatic dysfunction (bilirubin greater than IULN; transaminases greater than 2.5 x IULN) are not eligible.
  • Except for the following, no prior malignancy is allowed: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient has been disease free for 5 years.
  • Patients with clinically apparent cardiac disease, or history of same, are not eligible. Patients who are > 60 years of age or who have a history of hypertension must have a MUGA prior to enrollment. LVEF must be normal.
  • Patients who have received prior chemotherapy or radiotherapy are not eligible.
  • Patients who are pregnant or breastfeeding are not eligible. Women of child bearing potential must have a serum pregnancy test that is negative and agree to practice adequate contraception.
  • Patients with active infection are not eligible.
  • Patients who are known to be infected with HIV, hepatitis B or hepatitis C are not eligible. Testing is not required unless there is a high index of clinical suspicion.
  • Patients suffering from psychiatric impairment are not eligible.
  • Patients with known hypersensitivity to trimethoprim or sulfonamides are not eligible.

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 identifier (NCT number): NCT00194753

United States, Washington
University of Washington/Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
University of Washington
Bristol-Myers Squibb
Principal Investigator: Georgiana K. Ellis, M.D. University of Washington

Responsible Party: University of Washington Identifier: NCT00194753     History of Changes
Other Study ID Numbers: 18229-A
00-5889-A 07 ( Other Identifier: UW Human Subjects Division )
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 13, 2012
Last Verified: September 2012

Keywords provided by University of Washington:
Breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Adjuvants, Immunologic