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

April 21, 2022 updated by: Bjørn Naume, Oslo University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

1128

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0027
        • RRHF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Taxotere

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Disease free survival related to presence or absence of disseminated tumor cells
Time Frame: At approximately 8 years maximum FU
At approximately 8 years maximum FU

Secondary Outcome Measures

Outcome Measure
Time Frame
Predictive value of primary tumor markers on effects of docetaxel
Time Frame: At approximately 8 years maximum FU
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
At approximately of 8 years maximum FU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oslo University Hospital

Collaborators

Ullevaal University Hospital
University of Tromso
Helse Stavanger HF
Sorlandet Hospital HF
Sykehuset Innlandet HF
Alesund Hospital
Sykehuset Ostfold
Sykehuset i Vestfold HF

Investigators

  • Principal Investigator: Bjørn Naume, MD, PhD, Oslo University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2003

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

April 1, 2022

Study Registration Dates

First Submitted

November 3, 2005

First Submitted That Met QC Criteria

November 3, 2005

First Posted (ESTIMATE)

November 4, 2005

Study Record Updates

Last Update Posted (ACTUAL)

April 22, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NBCG9
  • S-03032
  • S-03-01434

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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