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Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer

This study has been completed.
Sponsor:
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
  Purpose

Primary Objectives:

  1. 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.
  2. 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:

  1. To discover a molecular profile that is associated with pCR after FAC chemotherapy alone
  2. To establish a prospectively collected gene expression profile data bank of breast cancer for future studies
  3. 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:


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:
  • 5-FU
  • Adrucil
  • Efudex
Drug: Cyclophosphamide

FAC and FEC Chemotherapy:

500 mg/m^2 IV on day 1 of 21 day cycle.

Other Names:
  • Cytoxan
  • Neosar
Drug: Doxorubicin
FAC Chemotherapy: 50 mg/m^2 IV on day 1 over 72 hour continuous infusion or IV bolus.
Other Names:
  • AD
  • Hydroxydaunomycin hydrochloride
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:
  • 5-FU
  • Adrucil
  • Efudex
Drug: Cyclophosphamide

FAC and FEC Chemotherapy:

500 mg/m^2 IV on day 1 of 21 day cycle.

Other Names:
  • Cytoxan
  • Neosar
Drug: Doxorubicin
FAC Chemotherapy: 50 mg/m^2 IV on day 1 over 72 hour continuous infusion or IV bolus.
Other Names:
  • AD
  • Hydroxydaunomycin hydrochloride
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:

  1. 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.
  2. Patients should have adequate organ function to tolerate chemotherapy.
  3. Patient must be willing to undergo a one-time pretreatment research FNA biopsy

Exclusion Criteria:

  1. 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.
  2. Patients with stage IV, metastatic breast cancers are not eligible.
  3. Patients for whom anthracycline or paclitaxel chemotherapies are contraindicated, for example Patients who are pregnant or lactating are not eligible.
  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: 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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Cyclophosphamide
Doxorubicin
Epirubicin
Fluorouracil
Liposomal doxorubicin
Paclitaxel
Alkylating Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Myeloablative Agonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014