Secondary Adjuvant Treatment for Patients With Isolated Tumor Cells in Bone Marrow

This study is currently recruiting participants.

Verified by Rikshospitalet HF, November 2005

Sponsors and Collaborators:	Rikshospitalet HF University of Tromso St. Olavs Hospital Sykehuset Rogaland, Stavanger, Reino Heikkilae, here@SIR.NO Sørlandet Sykehus, Kristiansand, Svein Mjaaland, svein.mjaaland@sshf.no OSS, Gjøvik, Kjetil Weyde, kjetil.weyde@sykehuset-innlandet.no Ullevaal University Hospital Sykehuset i Vestfold, Tønsberg, Karin Semb, karin.semb@siv.no Sykehuset i Østfold, Fredrikstad, Stein Gundersen, Stein.Gundersen@so-hf.no Ålesund Sjukehus, Ålesund, Liv Ellen Giske, liv.ellen.giske@helse-sunnmore.no
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00248703

Purpose

The purpose of the study is it to identify patients with persisting tumor cells after standard epirubicin-containing treatment to test a non-cross resistant chemotherapy regimen (docetaxel) for these patients and to explore the analysis of disseminated tumor cells in bone marrow as a surrogate marker for clinical outcome

Condition	Intervention	Phase
Breast Cancer	Drug: Docetaxel	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Factorial Assignment, Efficacy Study
Official Title:	Secondary Adjuvant (Rescue) Treatment With Docetaxel (Taxotere) and Detection of Isolated Tumor Cells in Bone Marrow as a Surrogate Marker for Effect in Node Positive and High Risk Node Negative Breast Cancer After Standard Adjuvant Epirubicin-Containing Treatment

Further study details as provided by Rikshospitalet HF:

Primary Outcome Measures:

ITC/DTC detection in bone marrow
Disease free survival

Secondary Outcome Measures:

Predictive value of primary tumor markers
Explore markers on tumor cells in BM

Estimated Enrollment:	1000
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2011

Detailed Description:

The presence of disseminating (or isolated) tumor cells (DTC/ITC) in bone marrow (BM) after completion of adjuvant chemotherapy for breast cancer is associated with poor prognosis. Methods for detection of DTC have potential as a tool for monitoring occult residual disease during follow up. Also, there exists potent chemotherapy proven to be effective when antracyclin-based chemotherapy fails (f.ex. docetaxel). Concequently, a study has been started to test DTC detection as a surrogate marker for clinical outcome in localized breast cancer patients, selected by the presence of DTC in BM after standard adjuvant chemotherapy, receiving secondary treatment with docetaxel. In brief, patients having received antracyclin-containing chemotherapy for localized breast cancer are candidates. After informed consent and no radiologic signs of distant metastasis, the first BM aspiration is performed at the end of radiotherapy or 8-12 weeks after last chemotherapy cycle. The next BM aspiration is performed 6 months later. At that time point the BMs are analyzed for the presence of DTC. If DTC are present in the 6 months BM test (the first BM sample is for exploratory research purposes), 6 cycles of docetacel are administered (3qw), followed by a third and forth BM analysis 1 month and 13 months after the end of chemotherapy. The patients receiving docetaxel with eradication of the DTC will be clinically compared to those with persistence of DTC after docetaxel treatment.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

Breast cancer with node positive disease or high risk node negative disease (pT1c/T2GII-IIIN0, pT3N0, cT3N0). Patients < 35 years with pT1a-bN0G2-3.
Primary surgery for breast cancer completed
Completed 6 cycles of adjuvant (or neoadjuvant) chemotherapy containing antracycline
Age  18 and < 70 years
ECOG or WHO performance status < 2 (see appendix I)
Written informed consent prior to beginning protocol specific procedures
Laboratory requirements (within 5 weeks prior to end of radiation treatment or within 5 weeks prior to completion of baseline examinations):
- Neutrophils  1.5 109/l
- Platelets  100 109/l
- Hemoglobin  10 g/dl
- Total bilirubin  upper normal limit (UNL)
- ASAT and ALAT  x 2.5 UNL (If ALP > 2.5  x 5 UNL,  ASAT and ALAT  x 1.5 UNL)
- ALP  x 5 UNL (If ASAT and ALAT > 1.5  x 2.5 UNL,  ALP  2.5 x UNL)
- Creatinine  175 umol/l
Completed staging analysis including chest X-ray, bone scintigraphy or MRI, liver ultrasound or liver CT scan

Exclusion criteria

Other (than breast carcinoma) earlier or concomitant carcinoma, except for skin and in situ cervix cancer
M1 breast cancer or locoregional recurrence of previously diagnosed breast cancer.
Earlier treatment with paclitaxel or docetaxel.
Pre-existing motor or sensory neurotoxicity of a severity  grad 2 by NCI criteria (see appendix II)
Cardiac disease with symptoms classified as NYHA  2 (see appendix III)
Definite contraindications for the use of corticosteroids
Concurrent treatment with other experimental drugs
Concurrent treatment with any other anti-cancer therapy (exept for endocrine therapy and trastuzumab)
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00248703

Contacts

Contact: Bjørn Naume, MD, PhD

+4722934000 ext 4732

bjorn.naume@radiumhospitalet.no

Locations

Norway
RRHF	Terminated
Oslo, Norway, 0027
RRHF	Recruiting
Oslo, Norway, 0027
Contact: Bjørn Naume, MD, PhD +4722934000 bjorn.naume@radiumhospitalet.no

Sponsors and Collaborators

Rikshospitalet HF

University of Tromso

St. Olavs Hospital

Sykehuset Rogaland, Stavanger, Reino Heikkilae, here@SIR.NO

Sørlandet Sykehus, Kristiansand, Svein Mjaaland, svein.mjaaland@sshf.no

OSS, Gjøvik, Kjetil Weyde, kjetil.weyde@sykehuset-innlandet.no

Ullevaal University Hospital

Sykehuset i Vestfold, Tønsberg, Karin Semb, karin.semb@siv.no

Sykehuset i Østfold, Fredrikstad, Stein Gundersen, Stein.Gundersen@so-hf.no

Ålesund Sjukehus, Ålesund, Liv Ellen Giske, liv.ellen.giske@helse-sunnmore.no

Investigators

Principal Investigator:

Bjørn Naume, MD,PhD

Rikshospitalet HF

More Information

Study ID Numbers:	NBCG9, S-03032, S-03-01434
Study First Received:	November 3, 2005
Last Updated:	November 3, 2005
ClinicalTrials.gov Identifier:	NCT00248703
Health Authority:	Norway:Norwegian Medicine Agency; Norway:The Data Inspectorate

Keywords provided by Rikshospitalet HF:

Disseminating tumor cells, bone marrow, breast cancer, docetaxel, adjuvant treatment

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Neoplasm Metastasis

Breast Neoplasms
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009