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

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ClinicalTrials.gov Identifier: NCT00248703
Recruitment Status : Active, not recruiting
First Posted : November 4, 2005
Last Update Posted : March 8, 2021
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):
Bjørn Naume, Oslo University Hospital

Tracking Information
First Submitted Date  ICMJE November 3, 2005
First Posted Date  ICMJE November 4, 2005
Last Update Posted Date March 8, 2021
Actual Study Start Date  ICMJE October 2003
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2009)
Disease free survival related to presence or absence of disseminated tumor cells [ Time Frame: At approximately 8 years maximum FU ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 3, 2005)
  • ITC/DTC detection in bone marrow
  • Disease free survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 9, 2009)
  • Predictive value of primary tumor markers on effects of docetaxel [ Time Frame: At approximately 8 years maximum FU ]
  • Explore markers on tumor cells in bone marrow that can predict the effect of docetaxel [ Time Frame: At approximately of 8 years maximum FU ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2005)
  • Predictive value of primary tumor markers
  • Explore markers on tumor cells in BM
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Secondary Adjuvant Treatment for Patients With Isolated Tumor Cells in Bone Marrow
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: Docetaxel
Docetaxel 100 mg/m2 3 qw x 6
Other Name: Taxotere
Study Arms  ICMJE 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.
Intervention: Drug: Docetaxel
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 20, 2012)
1128
Original Enrollment  ICMJE
 (submitted: November 3, 2005)
1000
Estimated Study Completion Date  ICMJE December 2022
Actual Primary Completion Date November 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00248703
Other Study ID Numbers  ICMJE NBCG9
S-03032
S-03-01434
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bjørn Naume, Oslo University Hospital
Study Sponsor  ICMJE Oslo University Hospital
Collaborators  ICMJE
  • University of Tromso
  • Helse Stavanger HF
  • Sorlandet Hospital HF
  • Sykehuset Innlandet HF
  • Ullevaal University Hospital
  • Sykehuset i Vestfold HF
  • Sykehuset Ostfold
  • Alesund Hospital
Investigators  ICMJE
Principal Investigator: Bjørn Naume, MD, PhD Oslo University Hospital
PRS Account Oslo University Hospital
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP