Biologic Correlative Taxotere/AC (TAX/AC)

This study has been completed.
Sponsor:
Collaborator:
Baylor College of Medicine
Information provided by (Responsible Party):
Baylor Breast Care Center
ClinicalTrials.gov Identifier:
NCT00206466
First received: September 13, 2005
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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).


Condition Intervention Phase
Breast Cancer
Drug: Taxotere
Drug: Adriamycin/cytoxan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Multicenter Trial of Neoadjuvant Taxotere and Adriamycin/Cytoxan(AC): A Biologic Correlative Study

Resource links provided by NLM:


Further study details as provided by Baylor Breast Care Center:

Primary Outcome Measures:
  • 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. [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine pathologic complete response and to correlate this to a prospectively determined Taxotere gene expression profile;time to tumor progression;overall survival [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: April 2002
Study Completion Date: January 2012
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: One
Taxotere
Drug: Taxotere
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.
Other Name: Docetaxel (Taxotere)
Drug: Adriamycin/cytoxan
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.
Other Name: doxorubicin 60 mg/m2 and cyclosphosphamide 600 mg/m2

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. All patients must be female.
  2. Signed informed consent.
  3. Primary breast cancers must be of clinical and/or radiologic size >3 cm, and deemed surgically operable.
  4. Negative serum pregnancy test (bHCG) within 7 days of starting study, if of child-bearing potential.
  5. 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.
  6. Renal function tests: creatinine within 1.5 times of the institution's upper limit of normal (ULN).
  7. Liver function tests: Total serum bilirubin within ULN, and liver transaminases within 2.5 times ULN, and alkaline phosphatase within 5 times ULN.
  8. Electrocardiogram showing no acute ischemic changes.
  9. Performance status (WHO scale) <2.
  10. Age > 18 years.
  11. Patients older than 70 years of age should have left ventricular ejection fraction within ULN by MUGA or 2D Echocardiogram.

Exclusion Criteria:

  1. Patients with metastatic breast cancer.
  2. Pregnancy or unwillingness to use a reliable contraceptive method in women of child-bearing potential.
  3. Women who are lactating or breastfeeding.
  4. Severe underlying chronic illness or disease.
  5. Peripheral neuropathy - grade 2 or greater.
  6. Patients on other investigational drugs while on study will be excluded.
  7. Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease.
  8. Prior taxane or anthracycline chemotherapy for malignancy.
  9. Patients with a history of severe hypersensitivity reaction to Taxotere or other drugs formulated with polysorbate 80.
  10. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00206466

Locations
United States, Texas
Baylor Breast Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor Breast Care Center
Baylor College of Medicine
Investigators
Principal Investigator: Mothaffar C Rimawi, MD Baylor Breast Center
  More Information

Additional Information:
No publications provided

Responsible Party: Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT00206466     History of Changes
Other Study ID Numbers: H-11624
Study First Received: September 13, 2005
Last Updated: January 24, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor Breast Care Center:
neoadjuvant
chemosensitivity
chemotherapy
breast cancer
tumor
taxotere
AC

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Liposomal doxorubicin
Doxorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014