NCT00403182

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

9 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 23, 2006

Completed
Last Updated

June 1, 2012

Status Verified

May 1, 2012

First QC Date

November 21, 2006

Last Update Submit

May 31, 2012

Conditions

Breast Cancer

Keywords

recurrent breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancerstage IV breast cancer

Outcome Measures

Primary Outcomes (1)

  • Overall survival

Secondary Outcomes (4)

  • 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

Interventions

chemotherapyDRUG
letrozoleDRUG

Eligibility Criteria

AgeUp to 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Kreiskrankenhaus

Ebersberg, D-85560, Germany

Location

Gynaekologische Gemeinschaftspraxis - Pause, Thiel & Neuhofer

Freising, D-85354, Germany

Location

Frauenklinik Universitaet Giessen

Giessen, D-35392, Germany

Location

Klinikum Ingolstadt

Ingolstadt, 85049, Germany

Location

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, D-23538, Germany

Location

Munich Oncologic Practice at Elisenhof

Munich, D-80335, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

Praxis Kowolik Prechtl-Sattler

Munich, D-81925, Germany

Location

Abt. Innere Medizin Onkologic

Schwarzenberg, 08340, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug TherapyLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Stefan Paepke, MD

    Technical University of Munich

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2006

First Posted

November 23, 2006

Study Start

May 1, 2006

Last Updated

June 1, 2012

Record last verified: 2012-05

Locations

DE(9)