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

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ClinicalTrials.gov Identifier: NCT00039546
Recruitment Status : Unknown
Verified May 2005 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: adjuvant therapy Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: 'tAnGo', A Phase III Randomised Trial Of Gemcitabine In Paclitaxel-Containing, Epirubicin-Based, Adjuvant Chemotherapy For ER/PgR-Poor, Early Stage, Breast Cancer
Study Start Date : August 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00039546


Locations
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Sponsors and Collaborators
Cancer Research Campaign Clinical Trials Centre
Investigators
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Study Chair: Helen Howard, PhD Cancer Research Campaign Clinical Trials Centre
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00039546    
Other Study ID Numbers: CRC-TU-TANGO
CDR0000069396 ( Registry Identifier: PDQ (Physician Data Query) )
EU-20058
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: May 2005
Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Cyclophosphamide
Gemcitabine
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
 Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors