Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00039546
First received: June 6, 2002
Last updated: August 6, 2013
Last verified: May 2005

June 6, 2002
August 6, 2013
August 2001
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Complete list of historical versions of study NCT00039546 on ClinicalTrials.gov Archive Site
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Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery
'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating women after surgery for breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine in treating women who have undergone surgery for breast cancer.

OBJECTIVES:

  • Compare the 5-year and 10-year disease-free survival and overall survival of women with completely resected early stage breast cancer treated with adjuvant paclitaxel, epirubicin, and cyclophosphamide with or without gemcitabine.
  • Compare the toxicity, dose-intensity, and tolerability of these regimens in these patients.
  • Compare the serious adverse events in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to nodal status (negative vs 1-3 vs 4 or more), age (50 and under vs over 50), estrogen receptor status (negative vs weakly positive vs positive), concurrent radiotherapy (no vs yes), HER2 status (3+ overexpression vs other vs not measured), and country. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive epirubicin IV, cyclophosphamide IV, and paclitaxel IV over 3 hours on day 1. Patients also receive gemcitabine IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II: Patients receive epirubicin, cyclophosphamide, and paclitaxel as in arm I.

Patients are followed every 3 months for 6 months, every 6 months for 3 years, and then annually for 6 years.

PROJECTED ACCRUAL: A total of 3,000 patients (1,500 per treatment arm) will be accrued for this study within 3-4 years.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Breast Cancer
  • Drug: cyclophosphamide
  • Drug: epirubicin hydrochloride
  • Drug: gemcitabine hydrochloride
  • Drug: paclitaxel
  • Procedure: adjuvant therapy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
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DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed invasive breast cancer

    • Early stage disease
    • Completely resected disease

      • No more than 8 weeks since prior resection
  • Any nodal status
  • Indication for adjuvant chemotherapy
  • No metastatic disease
  • Hormone receptor status:

    • Estrogen receptor negative or weakly positive OR
    • Estrogen receptor positive AND progesterone receptor negative or weakly positive

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • WBC greater than 3,000/mm3
  • Platelet count greater than 100,000/mm3
  • Hemoglobin greater than 9 g/dL

Hepatic:

  • Bilirubin normal
  • AST and ALT no greater than 1.5 times normal

Renal:

  • Creatinine no greater than 1.5 times normal

Other:

  • Fit to receive study chemotherapy
  • No active uncontrolled infection
  • No other malignancy within the past 10 years except basal cell carcinoma or carcinoma in situ of the cervix
  • No other concurrent medical or psychiatric problems that would preclude study
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00039546
CRC-TU-TANGO, CDR0000069396, EU-20058
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Cancer Research Campaign Clinical Trials Centre
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Study Chair: Helen Howard, PhD Cancer Research Campaign Clinical Trials Centre
National Cancer Institute (NCI)
May 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP