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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Tromso
Helse Stavanger HF
Sorlandet Hospital HF
Sykehuset Innlandet HF
Ullevaal University Hospital
Sykehuset i Vestfold HF
Sykehuset Ostfold
Alesund Hospital
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00248703
First received: November 3, 2005
Last updated: November 20, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is 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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Disease free survival related to presence or absence of disseminated tumor cells [ Time Frame: At approximately 8 years maximum FU ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Predictive value of primary tumor markers on effects of docetaxel [ Time Frame: At approximately 8 years maximum FU ] [ Designated as safety issue: No ]
  • Explore markers on tumor cells in bone marrow that can predict the effect of docetaxel [ Time Frame: At approximately of 8 years maximum FU ] [ Designated as safety issue: No ]

Enrollment: 1128
Study Start Date: October 2003
Estimated Study Completion Date: November 2013
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Docetaxel
Patients with presence of disseminated tumor cells in bone marrow after (no-taxane) epirubicin-containing adjuvant treatment receive 6 cycles of docetaxel (100 mg/m2) 3 qw.
 Drug: Docetaxel
Docetaxel 100 mg/m2 3 qw x 6
Other Name: Taxotere

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 anthracycline-based chemotherapy fails (f.ex. docetaxel). Consequently, 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 anthracycline-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 the 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 docetaxel 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:

  1. Breast cancer with node positive disease or high risk node negative disease (pT1c/T2GII-IIIN0, pT3N0, cT3N0). Patients < 35 years with pT1a-bN0G2-3.
  2. Primary surgery for breast cancer completed
  3. Completed 6 cycles of adjuvant (or neoadjuvant) chemotherapy containing anthracycline
  4. Age ≥ 18 and < 70 years
  5. Eastern Cooperative Oncology Group or WHO performance status < 2
  6. Written informed consent prior to beginning protocol specific procedures

  7. Laboratory requirements (within 5 weeks prior to end of radiation treatment or within 5 weeks prior to completion of baseline examinations):

    Neutrophils ≥ 1.1 10^9/l, Platelets ≥ 100 10^9/l, Hemoglobin ≥ 10 g/dl, ASAT and ALAT ≤ x 2.5 UNL (If ALP > 2.5 ≤ x 5 UNL, then ASAT and ALAT ≤ x 1.5 UNL), ALP ≤ x 5 UNL (If ASAT and ALAT > 1.5 ≤ x 2.5 UNL, then ALP ≤ 2.5 x UNL), Creatinine ≤ 175 umol/l

  8. Completed staging analysis including chest X-ray, bone scintigraphy or MRI, liver ultrasound or liver CT scan

Exclusion Criteria:

  1. Other (than breast carcinoma) earlier or concomitant carcinoma, except for skin and in situ cervix cancer
  2. M1 breast cancer or locoregional recurrence of previously diagnosed breast cancer.
  3. Earlier treatment with paclitaxel or docetaxel.
  4. Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI criteria (see appendix II)
  5. Cardiac disease with symptoms classified as NYHA ≥ 2
  6. Definite contraindications for the use of corticosteroids
  7. Concurrent treatment with other experimental drugs
  8. Concurrent treatment with any other anti-cancer therapy (except for endocrine therapy and trastuzumab)
  9. Pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248703

Locations
Norway
RRHF
Oslo, Norway, 0027
Sponsors and Collaborators
Oslo University Hospital
University of Tromso
Helse Stavanger HF
Sorlandet Hospital HF
Sykehuset Innlandet HF
Ullevaal University Hospital
Sykehuset i Vestfold HF
Sykehuset Ostfold
Alesund Hospital
Investigators
Principal Investigator: Bjørn Naume, MD, PhD Oslo University Hospital
  More Information

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00248703     History of Changes
Other Study ID Numbers: NBCG9, S-03032, S-03-01434
Study First Received: November 3, 2005
Last Updated: November 20, 2012
Health Authority: Norway: Norwegian Medicines Agency
Norway: Data Protection Authority

Keywords provided by Oslo University Hospital:
Disseminating tumor cells,breast cancer,docetaxel,adjuvant

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
 Docetaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013