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Chemotherapy and Hormone Therapy as First-Line Therapy in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00403182
Recruitment Status : Withdrawn (study halted prematurely, prior to enrollment of first participant)
First Posted : November 23, 2006
Last Update Posted : June 1, 2012
Information provided by:
Technische Universität München

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: chemotherapy Drug: letrozole Phase 3

Detailed Description:


  • 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The CORE Study (Chemotherapy OR Endocrine Treatment First?) A Randomized Study by the Scandinavian Breast Group [CORE]
Study Start Date : May 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Letrozole

Primary Outcome Measures :
  1. Overall survival

Secondary Outcome Measures :
  1. Response to first and second treatment modalities as assessed by RECIST criteria
  2. Time to first and second progression
  3. Toxicity and safety as assessed by NCI CTCAE v3.0
  4. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 74 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed breast cancer

    • Metastatic or locally advanced disease
    • Bilateral breast cancer allowed
  • Measurable or evaluable progressing metastases or local disease

    • No sclerotic bone metastases as only disease
    • Measurable or evaluable disease not in a previously irradiated area
  • No immediately life-threatening metastatic disease
  • No known HER2/neu positivity, as defined by either of the following:

    • 3+ by immunohistochemistry
    • HER2-positive by fluorescent in situ hybridization or chromogenic in situ hybridization
  • No known cerebral or leptomeningeal metastases
  • Hormone receptor status:

    • Estrogen and/or progesterone receptor positive tumor


  • Female
  • Postmenopausal, as defined by any of the following:

    • Bilateral oophorectomy and amenorrhea > 3 months
    • Radiation castration and amenorrhea > 3 months
    • Spontaneous menopause and amenorrhea > 12 months
    • Previous hysterectomy and age > 55 years
  • ECOG performance status 0-2

    • Must be ambulant with organ function and performance status adequate for conventional combination chemotherapy
  • No serious hypersensitivity to letrozole or other components of study drug
  • No other prior or concurrent malignancy except for basal cell carcinoma or carcinoma in situ of the cervix


  • No prior systemic treatment for recurrent or metastatic breast cancer
  • No other concurrent radiotherapy, endocrine therapy, cytotoxic therapy, or experimental therapy for cancer

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 identifier (NCT number): NCT00403182

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Ebersberg, Germany, D-85560
Gynaekologische Gemeinschaftspraxis - Pause, Thiel & Neuhofer
Freising, Germany, D-85354
Frauenklinik Universitaet Giessen
Giessen, Germany, D-35392
Klinikum Ingolstadt
Ingolstadt, Germany, 85049
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
Luebeck, Germany, D-23538
Munich Oncologic Practice at Elisenhof
Munich, Germany, D-80335
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
Munich, Germany, D-81675
Praxis Kowolik Prechtl-Sattler
Munich, Germany, D-81925
Abt. Innere Medizin Onkologic
Schwarzenberg, Germany, 08340
Sponsors and Collaborators
Technische Universität München
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Study Chair: Stefan Paepke, MD Technische Universität München
Layout table for additonal information Identifier: NCT00403182    
Other Study ID Numbers: CDR0000515936
First Posted: November 23, 2006    Key Record Dates
Last Update Posted: June 1, 2012
Last Verified: May 2012
Keywords provided by Technische Universität München:
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs