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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00248703
Recruitment Status : Active, not recruiting
First Posted : November 4, 2005
Last Update Posted : March 8, 2021
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):
Bjørn Naume, Oslo University Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1128 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : October 2003
Actual Primary Completion Date : November 2012
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Docetaxel

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Disease free survival related to presence or absence of disseminated tumor cells [ Time Frame: At approximately 8 years maximum FU ]

Secondary Outcome Measures :
  1. Predictive value of primary tumor markers on effects of docetaxel [ Time Frame: At approximately 8 years maximum FU ]
  2. Explore markers on tumor cells in bone marrow that can predict the effect of docetaxel [ Time Frame: At approximately of 8 years maximum FU ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00248703

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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
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Principal Investigator: Bjørn Naume, MD, PhD Oslo University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bjørn Naume, Principal investigator, Oslo University Hospital Identifier: NCT00248703    
Other Study ID Numbers: NBCG9
First Posted: November 4, 2005    Key Record Dates
Last Update Posted: March 8, 2021
Last Verified: March 2021
Keywords provided by Bjørn Naume, Oslo University Hospital:
Disseminating tumor cells,breast cancer,docetaxel,adjuvant
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action