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| Sponsor: | International Breast Cancer Study Group |
|---|---|
| Collaborators: |
National Cancer Institute (NCI) Breast International Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066807 |
Purpose
RATIONALE: Estrogen can stimulate the growth of breast tumor cells. Suppression of ovarian function combined with hormone therapy may fight breast cancer by reducing the production of estrogen. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether suppression of ovarian function and hormone therapy are more effective with or without chemotherapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying how well giving ovarian-function suppression together with hormone therapy and chemotherapy works compared to ovarian-function suppression and hormone therapy alone in treating premenopausal women with resected breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: chemotherapy Drug: exemestane Drug: tamoxifen citrate Drug: triptorelin Procedure: adjuvant therapy Procedure: oophorectomy Radiation: radiation therapy |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | A Phase III Trial Evaluating the Role of Chemotherapy as Adjuvant Therapy for Premenopausal Women With Endocrine Responsive Breast Cancer Who Receive Endocrine Therapy |
| Estimated Enrollment: | 1750 |
| Study Start Date: | August 2003 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, number of positive axillary and/or internal mammary lymph nodes (0 vs 1 or more), method of ovarian function suppression (triptorelin vs oophorectomy vs ovarian irradiation), chemotherapy if randomized to arm II (not containing vs containing an anthracycline or taxane), and endocrine agent (tamoxifen vs exemestane vs selected by subsequent randomization in the TEXT trial). Patients are randomized to 1 of 2 treatment arms.
Quality of life is assessed at baseline, every 6 months for 2 years, and then annually for 4 years.
Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 1,750 patients will be accrued for this study within 7 years.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer confined to the breast and axillary nodes
Must have undergone 1 of the following procedures for primary breast cancer within the past 12 weeks and have no known clinical residual locoregional disease:
Prior axillary lymph node dissection or negative axillary sentinel node biopsy required
No locally advanced, inoperable breast cancer, including any of the following characteristics:
No prior ipsilateral or contralateral invasive breast cancer
Hormone receptor status:
Estrogen receptor and/or progesterone receptor positive in each tumor
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Premenopausal
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
No prior or concurrent nonbreast invasive malignancy within the past 5 years that is nonrecurrent including any of the following:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No prior neoadjuvant or adjuvant chemotherapy
Endocrine therapy
No other concurrent oral or transdermal hormonal therapy, including any of the following:
Radiotherapy
Surgery
Other
Contacts and Locations| Hungary | |
| National Institute of Oncology | |
| Budapest, Hungary, 1122 | |
| Italy | |
| Centro di Riferimento Oncologico - Aviano | |
| Aviano, Italy, 33081 | |
| European Institute of Oncology | |
| Milan, Italy, 20141 | |
| Switzerland | |
| Kantonsspital Graubuenden | |
| Chur, Switzerland, CH-7000 | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| Centre Hospitalier Universitaire Vaudois | |
| Lausanne, Switzerland, 1011 | |
| Study Chair: | Rosalba Torrisi, MD | European Institute of Oncology |
| Study Chair: | Rosalba Torrisi, MD | European Institute of Oncology |
More Information
| Study ID Numbers: | CDR0000318832, IBCSG-26-02, BIG-4-02, NABCI-IBCSG-26-02, EU-20401, EUDRACT-2005-002626-59 |
| Study First Received: | August 6, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00066807 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IIIA breast cancer stage I breast cancer stage II breast cancer |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Contraceptive Agents Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Reproductive Control Agents Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Neoplasms by Site Therapeutic Uses |
Exemestane Aromatase Inhibitors Breast Diseases Estrogen Antagonists Antineoplastic Agents, Hormonal Skin Diseases Adjuvants, Immunologic Breast Neoplasms Enzyme Inhibitors Luteolytic Agents Tamoxifen Pharmacologic Actions Neoplasms Triptorelin |