NCT00336791

Brief Summary

Primary Objectives:

  1. 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. 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.
  3. 3.To discover a molecular profile that is associated with pCR after FAC chemotherapy alone
  4. 4.To establish a prospectively collected gene expression profile data bank of breast cancer for future studies
  5. 5.To compare the pCR rates between patients who receive 6 courses FAC and those who receive sequential paclitaxel /FAC chemotherapies.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P25-P50 for phase_3 breast-cancer

Timeline
Completed

Started Sep 2003

Typical duration for phase_3 breast-cancer

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
3.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

February 14, 2012

Status Verified

February 1, 2012

Enrollment Period

3.9 years

First QC Date

June 12, 2006

Last Update Submit

February 13, 2012

Conditions

Breast Cancer

Keywords

Breast CancerGene ExpressionFluorouracilCyclophosphamideDoxorubicinPaclitaxel

Outcome Measures

Primary Outcomes (1)

  • Pathologic Complete Response Rate in breast and axillary lymph nodes

    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.

    After completion of preoperative chemotherapy then every 6 months for 10 years.

Study Arms (2)

Paclitaxel + Additional FAC/FEC

EXPERIMENTAL

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-FluorouracilDrug: CyclophosphamideDrug: DoxorubicinDrug: PaclitaxelDrug: Epirubicin

FAC/FEC

ACTIVE COMPARATOR

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-FluorouracilDrug: CyclophosphamideDrug: DoxorubicinDrug: Epirubicin

Interventions

5-FluorouracilDRUG

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.

Also known as: 5-FU, Adrucil, Efudex
FAC/FECPaclitaxel + Additional FAC/FEC
CyclophosphamideDRUG

FAC and FEC Chemotherapy: 500 mg/m\^2 IV on day 1 of 21 day cycle.

Also known as: Cytoxan, Neosar
FAC/FECPaclitaxel + Additional FAC/FEC
DoxorubicinDRUG

FAC Chemotherapy: 50 mg/m\^2 IV on day 1 over 72 hour continuous infusion or IV bolus.

Also known as: AD, Hydroxydaunomycin hydrochloride
FAC/FECPaclitaxel + Additional FAC/FEC
PaclitaxelDRUG

80 mg/m\^2 by vein (IVPB) over 1 hour every week for 12 weeks

Also known as: Taxol
Paclitaxel + Additional FAC/FEC
EpirubicinDRUG

FEC: 100 mg/m\^2 IV on day 1 of 21 day cycle.

FAC/FECPaclitaxel + Additional FAC/FEC

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Centro Medico Nacional de Occidente

Guadalajara, Mexico

Location

Instituto Nacional de Enfermedades Neoplasicas

Lima, Peru

Location

Grupo Español de Investigacion en Cancer de Mama

Madrid, Spain

Location

Related Publications (1)

  • Desmedt C, Di Leo A, de Azambuja E, Larsimont D, Haibe-Kains B, Selleslags J, Delaloge S, Duhem C, Kains JP, Carly B, Maerevoet M, Vindevoghel A, Rouas G, Lallemand F, Durbecq V, Cardoso F, Salgado R, Rovere R, Bontempi G, Michiels S, Buyse M, Nogaret JM, Qi Y, Symmans F, Pusztai L, D'Hondt V, Piccart-Gebhart M, Sotiriou C. Multifactorial approach to predicting resistance to anthracyclines. J Clin Oncol. 2011 Apr 20;29(12):1578-86. doi: 10.1200/JCO.2010.31.2231. Epub 2011 Mar 21.

    PMID: 21422418DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FluorouracilCyclophosphamideDoxorubicinPaclitaxelEpirubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

UracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Lajos Pusztai, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2006

First Posted

June 14, 2006

Study Start

September 1, 2003

Primary Completion

August 1, 2007

Study Completion

September 1, 2010

Last Updated

February 14, 2012

Record last verified: 2012-02

Locations

PE(1)ME(1)US(1)ES(1)