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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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Breast Cancer

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Trial Information

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 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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Disease free survival related to presence or absence of disseminated tumor cells

Outcome Time Frame:

At approximately 8 years maximum FU

Safety Issue:

No

Principal Investigator

Bjørn Naume, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oslo University Hospital

Authority:

Norway: Norwegian Medicines Agency

Study ID:

NBCG9

NCT ID:

NCT00248703

Start Date:

October 2003

Completion Date:

November 2013

Related Keywords:

  • Breast Cancer
  • Disseminating tumor cells,breast cancer,docetaxel,adjuvant
  • Breast Neoplasms

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