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

This study has been withdrawn prior to enrollment.
(study halted prematurely, prior to enrollment of first participant)
Sponsor:
Information provided by:
Technische Universität München
ClinicalTrials.gov Identifier:
NCT00403182
First received: November 21, 2006
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Breast Cancer
Drug: chemotherapy
Drug: letrozole
Phase 3

Study Type: Interventional
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]

Resource links provided by NLM:


Further study details as provided by Technische Universität München:

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: May 2006
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   up to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • No prior systemic treatment for recurrent or metastatic breast cancer
  • No other concurrent radiotherapy, endocrine therapy, cytotoxic therapy, or experimental therapy for cancer
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00403182

Locations
Germany
Kreiskrankenhaus
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
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
Sponsors and Collaborators
Technische Universität München
Investigators
Study Chair: Stefan Paepke, MD Technische Universität München
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00403182     History of Changes
Other Study ID Numbers: CDR0000515936, KRDI-TUM-CORE-GYN-040-380-2126, EU-20660, EUDRACT-2005-000986-20, KRDI-TUM-COR-259-PAE-0100-I
Study First Received: November 21, 2006
Last Updated: May 31, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 11, 2014