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Sponsors and Collaborators: |
Baylor Breast Care Center Baylor College of Medicine |
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Information provided by: | Baylor Breast Care Center |
ClinicalTrials.gov Identifier: | NCT00206518 |
The purpose of this study is to learn if the biomarker information obtained (learned or received) from the earlier studies can tell us whether or not Taxotere and/or Adriamycin/Cytoxan can cause tumors to become smaller.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Taxotere Drug: Adriamycin/Cytoxan Drug: docetaxol Drug: doxorubicin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Multicenter Trial of Neoadjuvant Taxotere (T) and Adriamycin/Cytoxan (Ac): A Validation |
Estimated Enrollment: | 120 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | September 2012 |
Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Chemotherapy In Arm A, patients will receive single agent Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by standard adjuvant AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. This is done in order to minimize Adriamycin-induced cardiotoxicity.
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Drug: Taxotere
Taxotere
Drug: docetaxol
Taxotere (100 mg/m2) every 3 weeks for 4 cycles before surgery.
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B: Active Comparator
In Arm B, patients will receive AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery. For patients whose BSA is greater than 2.0 m2, the Adriamycin dosage will be calculated using BSA = 2.0 m2. Primary surgery will then be conducted, if operable, following completion of neoadjuvant treatment. This will be followed by 4 cycles of single agent Taxotere (100 mg/m2) every 3 weeks.
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Drug: Adriamycin/Cytoxan
Adriamycin/Cytoxan
Drug: doxorubicin
AC (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, every 3 weeks) for 4 cycles before surgery.
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Large clinical trials have confirmed the value of systemic adjuvant therapy in decreasing the risk of recurrence and death in patients with early breast cancer. However, the need to identify breast cancer patients who will benefit from adjuvant therapy, while sparing others from the side effects of futile treatment, is spurring research into predictive markers of chemotherapy sensitivity and resistance. In the adjuvant setting, extremely large trials and long follow-up would be required to prospectively validate the predictive value of biomarkers of chemotherapy sensitivity or resistance. In part this is because response is not directly observable. Preoperative chemotherapy for large tumors (>3cm) or inoperable breast cancer is well established and is the standard of care for locally advanced breast cancer. Data from large series of patients have demonstrated that preoperative (neoadjuvant) chemotherapy leads to significant reduction of tumor size (downstaging) and improves both the rate and the cosmetic results of breast- conserving surgery. The degree of response to neoadjuvant therapy has been shown to predict improved overall survival. This is therefore an attractive setting to study predictors of response because tissue is accessible from pre- therapeutic biopsies and tumor response is directly observable.
In an early proof-of-principle pilot study of single agent neoadjuvant docetaxol, we identified a predictive gene expression pattern, and, using leave-one-cross validation, a method of internal validation, we demonstrated that the pattern was likely to accurately discriminate between responders and non-responders (Chang, J.C., et al., Gene expression profiling for the prediction of therapeutic response to docetaxel in patients with breast cancer. Lancet, 2003. 362(9381): p. 362-9). A similar pilot study of neoadjuvant AC undertaken by a collaborator in the UK suggests that different profiles will be predictive for AC response.
In order to definitively determine predictive patterns for both regimens (T and AC) using improved technology for RNA preparation and a larger, more comprehensive gene expression array, we undertook a randomized Phase II trial of these two widely used regimens (Protocol H-11624 - A RANDOMIZED MULTICENTER TRIAL OF NEOADJUVANT TAXOTERE AND ADRIAMYCIN/CYTOXAN (AC): A BIOLOGIC CORRELATIVE STUDY). The trial is nearing completion, having recruited more than 90 patients out of an expected 120 patients. To date, the risks associated with this study have been modest, and there have been no unexpected adverse events. The laboratory work is well underway and gives every indication that clinically useful classifiers to predict treatment efficacy will result.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow function:
Renal function tests:
Liver function tests:
Exclusion Criteria:
Contact: Amber Froehlich, BS, CRC | 713-798-7814 | amberf@bcm.tmc.edu |
Contact: Anne Pavlick, BS, CRC | 713-798-6299 | pavlick@breastcenter.tmc.edu |
United States, Texas | |
Baylor Breast Center | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Brenda Reusser, BA 713-798-7814 breusser@breastcenter.tmc.edu | |
Contact: Anne Pavlick, CRC 713-798-6299 pavlick@breastcenter.tmc.edu | |
Sub-Investigator: Garrett Lynch, MD | |
Principal Investigator: Jenny Chang, MD | |
Sub-Investigator: Powel Brown, MD | |
Sub-Investigator: C Kent Osborne, MD | |
Sub-Investigator: Susan Hislenbeck | |
Sub-Investigator: Mothaffar Rimawi, MD |
Principal Investigator: | Jenny Chang, MD | Baylor Breast Center |
Responsible Party: | Baylor College of Medicine ( Jenny Chang ) |
Study ID Numbers: | H 16039 |
Study First Received: | September 14, 2005 |
Last Updated: | January 5, 2009 |
ClinicalTrials.gov Identifier: | NCT00206518 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Taxotere |
AC Validation Neoadjuvant |
Docetaxel Anti-Bacterial Agents Immunologic Factors Skin Diseases Breast Neoplasms Antineoplastic Agents, Alkylating |
Cyclophosphamide Antirheumatic Agents Alkylating Agents Immunosuppressive Agents Doxorubicin Breast Diseases |
Molecular Mechanisms of Pharmacological Action Skin Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms Cyclophosphamide Antibiotics, Antineoplastic Immunosuppressive Agents Doxorubicin |
Pharmacologic Actions Docetaxel Neoplasms Neoplasms by Site Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents Breast Diseases |