Biologic Correlative Taxotere/AC

NCT00206466 | Completed Phase 2

• 1 other identifier: H-11624
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

We are asking you to take part in a research study of biomarkers (characteristics or traits of the genes inside cancer cells). We want to learn if these biomarkers could help us learn how well your breast cancer may respond (improve) to chemotherapy (drugs to treat cancer).

Conditions

Breast Cancer

Keywords

neoadjuvant; chemosensitivity; chemotherapy; breast cancer; tumor; taxotere; AC

Outcome Measures

Primary Outcomes (1)

• The primary objective this extension study is to obtain enough additional cases evaluable for microarray analyses to complete our studies to identify profiles of a small number of genes that are predictive of response.

  10 years

Secondary Outcomes (1)

• To determine pathologic complete response and to correlate this to a prospectively determined Taxotere gene expression profile;time to tumor progression;overall survival

  10 years

Study Arms (1)

One

ACTIVE COMPARATOR

Taxotere

Drug: Taxotere; Drug: Adriamycin/cytoxan

Interventions

Taxotere DRUG

Docetaxel (Taxotere) 100 mg/m2 is to be administered on day 1. A core biopsy is to be performed one day after chemotherapy (day 2) and on days 8, 15 and 22. On day 22, after repeat core biopsy, a second cycle of docetaxel (Taxotere) chemotherapy (100 mg/m2) will be given. Docetaxel (Taxotere) will be given three-weekly for a total of four cycles. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.

Also known as: Docetaxel (Taxotere)

One

Adriamycin/cytoxan DRUG

Adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every three weeks) for four cycles will then be administered. Adjuvant radiotherapy will be considered following completion of AC chemotherapy. Patients whose tumors were ER and/or PgR positive would be commenced on tamoxifen for five years after completion of AC chemotherapy.

Also known as: doxorubicin 60 mg/m2 and cyclosphosphamide 600 mg/m2

One

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must be female.
• Signed informed consent.
• Primary breast cancers must be of clinical and/or radiologic size \>3 cm, and deemed surgically operable.
• Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
• Adequate bone marrow function: Hematocrit of greater than 30%, total neutrophil count must be \>1.5 x 109/L and platelets of \> 100 x 109/L prior to the start of any cycle.
• Renal function tests: creatinine within 1.5 times of the institution's upper limit of normal (ULN).
• Liver function tests: Total serum bilirubin within ULN, and liver transaminases within 2.5 times ULN, and alkaline phosphatase within 5 times ULN.
• Electrocardiogram showing no acute ischemic changes.
• Performance status (WHO scale) \<2.
• Age \> 18 years.
• Patients older than 70 years of age should have left ventricular ejection fraction within ULN by MUGA or 2D Echocardiogram.

You may not qualify if:

• Patients with metastatic breast cancer.
• Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
• Women who are lactating or breastfeeding.
• Severe underlying chronic illness or disease.
• Peripheral neuropathy - grade 2 or greater.
• Patients on other investigational drugs while on study will be excluded.
• Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease.
• Prior taxane or anthracycline chemotherapy for malignancy.
• Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80.
• No previous or current malignancies at other sites within the last 5 years, with exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.

Sponsors & Collaborators

• Baylor Breast Care Center: lead
• Baylor College of Medicine: collaborator

Study Sites (1)

Baylor Breast Center

Houston, Texas, 77030, United States

Location

Related Links

• Web Site

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Docetaxel; Doxorubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Mothaffar C Rimawi, MD

  Baylor Breast Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2002
• Primary Completion: April 1, 2006
• Study Completion: January 1, 2012
• Last Updated: January 25, 2012

Record last verified: 2012-01

Locations

US (1)