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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00194753
• Date of registration: 14/09/2005
• Primary sponsor: University of Washington
• Public title: Adjuvant Therapy for High-Risk Breast Cancer With Wkly Adriamycin & Oral Cytoxan With G-CSF for 12 Wks; Wkly Taxol x 12
• Scientific 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
• Date of first enrolment: December 2001
• Target sample size: 80
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00194753
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Georgiana K. Ellis, M.D.
• Affiliation: University of Washington

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Breast Neoplasm

Intervention(s)

Drug: Cyclophosphamide

Drug: Doxorubicin

Drug: G-CSF

Drug: Paclitaxel

Primary Outcome(s)

Delivered dose intensity [Time Frame: 24 weeks]

Toxicity [Time Frame: 24 weeks]

Secondary Outcome(s)

Overall survival [Time Frame: 7 years]

Time to treatment failure [Time Frame: 7 years]

Secondary ID(s)

00-5889-A 07

18229-A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Amgen

Bristol-Myers Squibb