Adjuvant Breast Cancer Study of the Netherlands Working Party for Autotransplantation in Solid Tumors
|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.|
|ClinicalTrials.gov Identifier: NCT00851110|
Recruitment Status : Terminated
First Posted : February 25, 2009
Last Update Posted : February 25, 2009
Objectives of the study:
This randomized multicenter phase II study compares the tolerability, toxicity and quality of life between two high-dose chemotherapy regimens based on cyclophosphamide, thiotepa and carboplatin.
Regimen A: full dose CTC. Regimen B: two courses of CTC (tCTC) with 33% dose reduction.
Primary endpoints are:
- Maximum degree of non-hematological toxicity.
- Total number of hospital days.
- Quality of life evaluations during and following high-dose chemotherapy (up to 1 year).
- Effect of therapeutic dose monitoring of CTC or tCTC.
This investigation is a multicenter prospective randomized phase II study. Patients eligible for the study will be identified after mastectomy or wide tumor excision with axillary clearance. Following randomization, all patients will receive four courses of cyclophosphamide, epirubicin and fluorouracil (FEC). Patients with early progressive disease at any time will be taken off study. The first chemotherapy course must be given as soon as possible after the surgical procedure, preferably within 3 weeks, but not later than 6 weeks since primary surgery. After the third or fourth FEC course G-CSF is administered and peripheral stem cells will be harvested. All radiation therapy (including radiation therapy administered as part of a breast conserving strategy) must be postponed until all chemotherapy has been concluded.
Questionnaires, comprising the Rotterdam Symptom Checklist (RSCL) and the Short-Form General Health Survey (SF-36) will be sent by mail before randomization, after chemotherapy, 3 months thereafter, further on every l/2 yr till at least 1 year follow-up as performed earlier. [6, 28, 29].
All patients will be randomized before the initiation of chemotherapy.
- The 'standard' treatment arm will include 4 courses of FEC followed by high-dose chemotherapy with a single course of full dose CTC followed by peripheral stem cell reinfusion. Subsequently, conventional external beam radiotherapy to the breast or chest wall and to the regional lymph node areas including the axilla and the parasternal area will be administered following guidelines of the individual center. Patients with hormone receptor positive disease will go on to receive 5 years of tamoxifen. Patients with receptor positive disease who have not entered menopause will be advised to undergo ovarian ablation as well.
- The 'experimental' treatment arm will be identical to the 'standard' one, except that the single course of CTC will be replaced by 2 courses of tCTC each followed by peripheral stem cell reinfusion.
|Condition or disease||Intervention/treatment||Phase|
|High-Risk Breast Cancer||Procedure: stem cell reinfusion Drug: Chemotherapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Randomized Feasibility and Phase II Adjuvant Breast Cancer Study of the Netherlands Working Party for Autotransplantation in Solid Tumors.|
|Study Start Date :||October 2004|
- Procedure: stem cell reinfusion
hematopoietic stem cell reinfusion
- Drug: Chemotherapy
High-dose chemotherapy consisting of cyclophosphamide, thiotepa and carboplatin
- Maximum degree of non-hematological toxicity.
- Total number of hospital days
- Quality of life evaluations during and following high-dose chemotherapy (up to 1 year)
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 ClinicalTrials.gov identifier (NCT number): NCT00851110
|Free University Hospital|
|Amsterdam, Netherlands, 1007 MB|
|The Netherlands Cancer Institute|
|Amsterdam, Netherlands, 1066 CX|
|Academic Medical Center|
|Amsterdam, Netherlands, 1105 AZ|
|Medisch Spectrum Twente|
|Enschede, Netherlands, 7511 JX|
|University Medical Centre Groningen|
|Groningen, Netherlands, 9713 GZ|
|Leiden University Medical Centre|
|Leiden, Netherlands, 2333 JS|
|University Hospital Maastricht|
|Maastricht, Netherlands, 6202 AZ|
|University Medical Centre Nijmegen St. Radboud|
|Nijmegen, Netherlands, 6525 GA|
|Erasmus MC, Daniel den Hoed Cancer Center|
|Rotterdam, Netherlands, 3075 EA|
|University Medical Centre Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Study Director:||Elisabeth G.E. de Vries, MD, PhD||University Medical Center Groningen|
|Study Director:||Sjoerd Rodenhuis, MD, PhD||The Netherlands Cancer Institute|