Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer
This study has been completed.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Breast Cancer Research Foundation
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00336791
First received: June 12, 2006
Last updated: February 13, 2012
Last verified: February 2012
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Purpose
Primary Objectives:
- To prospectively evaluate the predictive accuracy of a previously discovered gene expression profile-based test to foretell pathologic complete response (pCR) to preoperative paclitaxel/FAC (5-fluorouracil, doxorubicin, cyclophosphamide) chemotherapy for stage I-III breast cancer.
- To evaluate if our genomic predictive test is specific to the paclitaxel/FAC regimen or it also predicts increased sensitivity to FAC only chemotherapy.
Secondary Objectives:
- To discover a molecular profile that is associated with pCR after FAC chemotherapy alone
- To establish a prospectively collected gene expression profile data bank of breast cancer for future studies
- To compare the pCR rates between patients who receive 6 courses FAC and those who receive sequential paclitaxel /FAC chemotherapies.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: 5-Fluorouracil Drug: Cyclophosphamide Drug: Doxorubicin Drug: Paclitaxel Drug: Epirubicin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression Profile-Based Test to Select Patients for Preoperative Taxane/Anthracycline Chemotherapy for Stage I-III Breast Cancer |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Cyclophosphamide
Fluorouracil
Doxorubicin
Doxorubicin hydrochloride
Paclitaxel
Epirubicin hydrochloride
Epirubicin
U.S. FDA Resources
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Pathologic Complete Response Rate in breast and axillary lymph nodes [ Time Frame: After completion of preoperative chemotherapy then every 6 months for 10 years. ] [ Designated as safety issue: No ]Pathologic Complete Response Rate after completion of preoperative chemotherapy, based on routine clinical pathology report where Pathologic complete response defined as complete absence of any viable invasive cancer cells in resected breast and lymph nodes. Specimens in breast may contain in situ cancer (ductal or lobular carcinoma in situ) and still be considered complete response.
| Enrollment: | 273 |
| Study Start Date: | September 2003 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Paclitaxel + Additional FAC/FEC
12 weekly Paclitaxel treatments 80 mg/m^2 by vein (IVPB) over 1 hour + 4 additional FAC or FEC combination chemotherapy treatments; FAC or FEC treatments given once every 3 weeks. FAC Chemotherapy: 5-Fluorouracil 500 mg/m^2 intravenous (IV) day 1 & 4 + Doxorubicin 50 mg/m^2 IV day 1 over 72 hour continuous infusion or IV bolus + Cyclophosphamide 500 mg/m^2 IV day 1. FEC Chemotherapy: 5-Fluorouracil 500 mg/m^2 IV day 1 + Epirubicin 100 mg/m^2 IV day 1 + Cyclophosphamide 500 mg/m^2 IV day 1. |
Drug: 5-Fluorouracil
FEC Chemotherapy: 500 mg/m^2 IV on day 1 of 21 day cycle. FAC Chemotherapy: 500 mg/m^2 IV on day 1 and day 4 of 21 day cycle. Other Names:
Drug: Cyclophosphamide
FAC and FEC Chemotherapy: 500 mg/m^2 IV on day 1 of 21 day cycle. Other Names:
Drug: Doxorubicin
FAC Chemotherapy: 50 mg/m^2 IV on day 1 over 72 hour continuous infusion or IV bolus.
Other Names:
Drug: Paclitaxel
80 mg/m^2 by vein (IVPB) over 1 hour every week for 12 weeks
Other Name: Taxol
Drug: Epirubicin
FEC: 100 mg/m^2 IV on day 1 of 21 day cycle.
|
|
Active Comparator: FAC/FEC
6 courses FAC or FEC Combination Chemotherapy FAC Chemotherapy: 5-Fluorouracil 500 mg/m^2 intravenous (IV) day 1 & 4 + Doxorubicin 50 mg/m^2 IV day 1 over 72 hour continuous infusion or IV bolus + Cyclophosphamide 500 mg/m^2 IV day 1. FEC Chemotherapy: 5-Fluorouracil 500 mg/m^2 IV day 1 + Epirubicin 100 mg/m^2 IV day 1 + Cyclophosphamide 500 mg/m^2 IV day 1. |
Drug: 5-Fluorouracil
FEC Chemotherapy: 500 mg/m^2 IV on day 1 of 21 day cycle. FAC Chemotherapy: 500 mg/m^2 IV on day 1 and day 4 of 21 day cycle. Other Names:
Drug: Cyclophosphamide
FAC and FEC Chemotherapy: 500 mg/m^2 IV on day 1 of 21 day cycle. Other Names:
Drug: Doxorubicin
FAC Chemotherapy: 50 mg/m^2 IV on day 1 over 72 hour continuous infusion or IV bolus.
Other Names:
Drug: Epirubicin
FEC: 100 mg/m^2 IV on day 1 of 21 day cycle.
|
Show Detailed Description Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed stage I-III invasive carcinoma of the breast for whom adjuvant chemotherapy is indicated. Patients must have intact or measurable residual cancer (by mammogram, ultra sonogram or physical exam) in the breast. Women of childbearing potential must have a negative pregnancy test (serum or urine beta Human chorionic gonadotropin (HCG)) prior to initiation of chemotherapy.
- Patients should have adequate organ function to tolerate chemotherapy.
- Patient must be willing to undergo a one-time pretreatment research FNA biopsy
Exclusion Criteria:
- Patients who have completed lumpectomy, segmental mastectomy or modified radical mastectomy and, therefore no longer have any measurable cancer left in their breast are not eligible.
- Patients with stage IV, metastatic breast cancers are not eligible.
- Patients for whom anthracycline or paclitaxel chemotherapies are contraindicated, for example Patients who are pregnant or lactating are not eligible.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00336791
Locations
| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Mexico | |
| Centro Medico Nacional de Occidente | |
| Guadalajara, Mexico | |
| Peru | |
| Instituto Nacional de Enfermedades Neoplasicas | |
| Lima, Peru | |
| Spain | |
| Grupo Español de Investigacion en Cancer de Mama | |
| Madrid, Spain | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Breast Cancer Research Foundation
Investigators
| Principal Investigator: | Lajos Pusztai, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided by M.D. Anderson Cancer Center
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00336791 History of Changes |
| Other Study ID Numbers: | 2003-0321 |
| Study First Received: | June 12, 2006 |
| Last Updated: | February 13, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by M.D. Anderson Cancer Center:
|
Breast Cancer Gene Expression Fluorouracil |
Cyclophosphamide Doxorubicin Paclitaxel |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Cyclophosphamide Fluorouracil Doxorubicin Epirubicin Paclitaxel Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
Antirheumatic Agents Therapeutic Uses Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Antimetabolites Antimetabolites, Antineoplastic Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on June 17, 2013