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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

Phase 2
18 Years
Not Enrolling
Breast Neoplasm

Thank you

Trial Information

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

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.

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

- 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

- 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

- Patients suffering from psychiatric impairment are not eligible.

- Patients with known hypersensitivity to trimethoprim or sulfonamides are not

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Delivered dose intensity

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Georgiana K. Ellis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Washington


United States: Institutional Review Board

Study ID:




Start Date:

December 2001

Completion Date:

March 2011

Related Keywords:

  • Breast Neoplasm
  • Breast cancer
  • Breast Neoplasms
  • Neoplasms



University of Washington/Seattle Cancer Care Alliance Seattle, Washington  98109