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Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Adenocarcinoma
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Breast Cancer Stage T1-3, N1, M0

- Suitable candidate for anthracycline-containing adjuvant chemotherapy

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence of residual tumor following surgery, or metastatic disease

- Received prior therapy for breast cancer

NCT00140075
Pfizer
Completed
Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer

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Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer
Phase III, Randomized Study Of Epirubicin/Cyclophosphamide Followed By Taxane (Sequential Chemotherapy) Versus Epirubicin/Taxane (Concurrent Chemotherapy) As Adjuvant Treatment For Operable, Node-Positive Breast Cancer
The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Adenocarcinoma
  • Drug: Epirubicin with Cyclophosphamide, followed by a Taxane

    Epirubicin = 90 mg/m2 Cyclophosphamide = 600 mg/m2

    Followed by a taxane; paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2

    Other Name: Epirubicin, ellence,
  • Drug: Epirubicin with a Taxane

    Epirubicin = 75 mg/m2 per cycle

    Taxane = paclitaxel = 175 mg/m2 or docetaxel = 75 mg/m2

    Other Name: Epirubicin, ellence,
  • Experimental: B

    ET (8 cycles)

    T = docetaxel or paclitaxel

    Intervention: Drug: Epirubicin with a Taxane
  • Experimental: A

    EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles

    T = docetaxel or paclitaxel

    Intervention: Drug: Epirubicin with Cyclophosphamide, followed by a Taxane
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
606
August 2006
August 2006   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Breast Cancer Stage T1-3, N1, M0
  • Suitable candidate for anthracycline-containing adjuvant chemotherapy

Exclusion Criteria:

  • Evidence of residual tumor following surgery, or metastatic disease
  • Received prior therapy for breast cancer
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00140075
378-ONC-0030-184
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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