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
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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 |
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 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 |
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
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
Study Chair: | Helen Howard, PhD | Cancer Research Campaign Clinical Trials Centre |
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 |
stage I breast cancer stage II breast cancer |
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 |