Chemotherapy and Hormone Therapy as First-Line Therapy in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether giving chemotherapy before hormone therapy is more effective than giving hormone therapy before chemotherapy in treating breast cancer.
PURPOSE: This randomized phase III trial is studying chemotherapy to see how well it works when given before or after hormone therapy as first-line therapy in treating postmenopausal women with metastatic or locally advanced breast cancer.
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The CORE Study (Chemotherapy OR Endocrine Treatment First?) A Randomized Study by the Scandinavian Breast Group [CORE]|
- Overall survival [ Designated as safety issue: No ]
- Response to first and second treatment modalities as assessed by RECIST criteria [ Designated as safety issue: No ]
- Time to first and second progression [ Designated as safety issue: No ]
- Toxicity and safety as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
- Quality of life as assessed by Hospital Anxiety and Depression Scale (HADS-D), Functional Assessment of Cancer Therapy-General (FACT-G), FBK-R23, and FLZ-G periodically for 5 years [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
- Determine the optimal sequence of chemotherapy and endocrine therapy as first-line therapy in postmenopausal women with metastatic or locally advanced breast cancer that is potentially sensitive to both modalities.
OUTLINE: This is an open-label, randomized, crossover, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.
- Arm I (chemotherapy first): Beginning within 4 weeks after randomization, patients receive chemotherapy* comprising either an anthracycline- or a taxane-based regimen, or a combination of both drugs, according to local institutional guidelines. Treatment continues for 6 months or longer, in the absence of disease progression or unacceptable toxicity. After discontinuation of chemotherapy, patients receive endocrine therapy comprising oral letrozole once daily in the absence of disease progression or unacceptable toxicity. Patients with immediately life-threatening disease (e.g., lymphangitis carcinomatosa or liver involvement exceeding 1/3 of the liver) are recommended for second-line chemotherapy.
NOTE: *Patients may receive chemotherapy on a separate clinical chemotherapy trial but must first undergo randomization in this study.
- Arm II (endocrine therapy first):Beginning immediately after randomization, patients receive oral letrozole once daily in the absence of disease progression or unacceptable toxicity. Patients who demonstrate progressive disease then receive chemotherapy as in arm I.
Quality of life and pain are assessed at baseline and then periodically for 5 years.
After completion of study therapy, patients are followed periodically.
PROJECTED ACCRUAL: A total of 1,500 patients will be accrued for this study.
|Ebersberg, Germany, D-85560|
|Gynaekologische Gemeinschaftspraxis - Pause, Thiel & Neuhofer|
|Freising, Germany, D-85354|
|Frauenklinik Universitaet Giessen|
|Giessen, Germany, D-35392|
|Ingolstadt, Germany, 85049|
|Universitaetsklinikum Schleswig-Holstein - Campus Luebeck|
|Luebeck, Germany, D-23538|
|Klinikum Rechts Der Isar - Technische Universitaet Muenchen|
|Munich, Germany, D-81675|
|Munich Oncologic Practice at Elisenhof|
|Munich, Germany, D-80335|
|Praxis Kowolik Prechtl-Sattler|
|Munich, Germany, D-81925|
|Abt. Innere Medizin Onkologic|
|Schwarzenberg, Germany, 08340|
|Study Chair:||Stefan Paepke, MD||Technische Universität München|