Combination Chemotherapy in Treating Women With Breast Cancer Who Have Undergone Surgery - Full Text View

Sponsor:	Cancer Research Campaign Clinical Trials Centre
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00039546

Purpose

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	Intervention	Phase
Breast Cancer	Drug: cyclophosphamide Drug: epirubicin hydrochloride Drug: gemcitabine hydrochloride Drug: paclitaxel Procedure: adjuvant therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

Drug Information available for: Cyclophosphamide Paclitaxel Epirubicin hydrochloride Epirubicin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 2001

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00039546

Show 46 Study Locations

Sponsors and Collaborators

Cancer Research Campaign Clinical Trials Centre

Investigators

Study Chair:

Helen Howard, PhD

Cancer Research Campaign Clinical Trials Centre

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069396, CRC-TU-TANGO, EU-20058
Study First Received:	June 6, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00039546 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Cyclophosphamide
Antibiotics, Antineoplastic
Neoplasms by Site
Therapeutic Uses
Gemcitabine
Alkylating Agents
Breast Diseases
Skin Diseases

Mitosis Modulators
Adjuvants, Immunologic
Breast Neoplasms
Enzyme Inhibitors
Antimitotic Agents
Epirubicin
Immunosuppressive Agents
Antiviral Agents
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Paclitaxel
Tubulin Modulators
Myeloablative Agonists
Antineoplastic Agents, Alkylating

ClinicalTrials.gov processed this record on November 22, 2009