Status:
COMPLETED
Secondary Adjuvant Treatment for Patients With Isolated Tumor Cells in Bone Marrow
Lead Sponsor:
Oslo University Hospital
Collaborating Sponsors:
University of Tromso
Helse Stavanger HF
Conditions:
Breast Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 pa...
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 detecti...
Eligibility Criteria
Inclusion
- Breast cancer with node positive disease or high risk node negative disease (pT1c/T2GII-IIIN0, pT3N0, cT3N0). Patients \< 35 years with pT1a-bN0G2-3.
- Primary surgery for breast cancer completed
- Completed 6 cycles of adjuvant (or neoadjuvant) chemotherapy containing anthracycline
- Age ≥ 18 and \< 70 years
- Eastern Cooperative Oncology Group or WHO performance status \< 2
- Written informed consent prior to beginning protocol specific procedures
- 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
- Completed staging analysis including chest X-ray, bone scintigraphy or MRI, liver ultrasound or liver CT scan
Exclusion
- Other (than breast carcinoma) earlier or concomitant carcinoma, except for skin and in situ cervix cancer
- M1 breast cancer or locoregional recurrence of previously diagnosed breast cancer.
- Earlier treatment with paclitaxel or docetaxel.
- Pre-existing motor or sensory neurotoxicity of a severity ≥ grade 2 by NCI criteria (see appendix II)
- Cardiac disease with symptoms classified as NYHA ≥ 2
- Definite contraindications for the use of corticosteroids
- Concurrent treatment with other experimental drugs
- Concurrent treatment with any other anti-cancer therapy (except for endocrine therapy and trastuzumab)
- Pregnancy
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
1128 Patients enrolled
Trial Details
Trial ID
NCT00248703
Start Date
October 1 2003
End Date
April 1 2022
Last Update
April 22 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
RRHF
Oslo, Norway, 0027