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

May 31, 2012 updated by: Technical University of Munich

The CORE Study (Chemotherapy OR Endocrine Treatment First?) A Randomized Study by the Scandinavian Breast Group [CORE]

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 Overview

Status

Withdrawn

Conditions

Breast Cancer

Intervention / Treatment

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.

Study Type

Interventional

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Germany
- - Ebersberg, Germany, D-85560
    - Kreiskrankenhaus
  - Freising, Germany, D-85354
    - Gynaekologische Gemeinschaftspraxis - Pause, Thiel & Neuhofer
  - Giessen, Germany, D-35392
    - Frauenklinik Universitaet Giessen
  - Ingolstadt, Germany, 85049
    - Klinikum Ingolstadt
  - Luebeck, Germany, D-23538
    - Universitaetsklinikum Schleswig-Holstein - Campus Luebeck
  - Munich, Germany, D-81675
    - Klinikum Rechts der Isar - Technische Universitaet Muenchen
  - Munich, Germany, D-80335
    - Munich Oncologic Practice at Elisenhof
  - Munich, Germany, D-81925
    - Praxis Kowolik Prechtl-Sattler
  - Schwarzenberg, Germany, 08340
    - Abt. Innere Medizin Onkologic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 74 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Overall survival

Secondary Outcome Measures

Outcome Measure
Response to first and second treatment modalities as assessed by RECIST criteria
Time to first and second progression
Toxicity and safety as assessed by NCI CTCAE v3.0
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technical University of Munich

Investigators

Study Chair: Stefan Paepke, MD, Technical University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Study Registration Dates

First Submitted

November 21, 2006

First Submitted That Met QC Criteria

November 21, 2006

First Posted (Estimate)

November 23, 2006

Study Record Updates

Last Update Posted (Estimate)

June 1, 2012

Last Update Submitted That Met QC Criteria

May 31, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.