To detect any effect on disease-free survival from treatment with 3 neo-adjuvant and 3 adjuvant chemotherapy cycles (standard treatment) versus 6 neo-adjuvant chemotherapy cycles To study the effect of GM-CSF versus G-CSF on potential effect on…
ID
Bron
Verkorte titel
Aandoening
Locally advanced breast cancer.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Recurrence of disease or all cause mortality (whichever comes first).
Achtergrond van het onderzoek
The study has ceased due to a stop of procedure GM-CSF by the manufacturer.
De studie is gestaakt vanwege stop procedure GM-CSF door de fabrikant.
Doel van het onderzoek
To detect any effect on disease-free survival from treatment with 3 neo-adjuvant and 3 adjuvant chemotherapy cycles (standard treatment) versus 6 neo-adjuvant chemotherapy cycles
To study the effect of GM-CSF versus G-CSF on potential effect on disease-free survival.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Arm A:
6 neoadjuvant cycles doxorubicin and cyclophosphamide;
Arm B:
3 neoadjuvant + 3 adjuvant cycles doxorubicin and cyclophosphamideIn each study arm 50% of the patients will receive GM-CSF(250 ìg/m2 daily sc day 2-12) and 50% G-CSF (5 ìg/kg daily sc day 2-12) in a randomised fashion. Doxorubicin and cyclophosphamide are administered on day 1 every 3 weeks.
Doses of doxorubicin :
Cycle 1 90 mg/m2;
Cycles 2-3 82.5 mg/m2;
Cycles 4-C6 75 mg/m2
Doses of cyclophosphamide:
Cycle 1 1000 mg/m2;
Cycles 2-3 875 mg/m2;
Cycles 4-6 750 mg/m2
Publiek
P.O. Box 7057
H.M. Pinedo
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444342
hm.pinedo@vumc.nl
Wetenschappelijk
P.O. Box 7057
H.M. Pinedo
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4444342
hm.pinedo@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Histologically proven breast cancer;
2. Locally advanced breast cancer: stage IIB with a primary breast tumor > 5 cm ©ª (T3 tumor), IIIA or IIIB according to the AJCC criteria;
3. Adequate hematological, renal and hepatic functions (WBC ¡Ã3.0 x 109/l, platelets ¡Ã 150 x 109/l); normal serum bilirubin; normal ASAT (SGOT), ALAT (SGPT) and AF, normal serum creatinine;
4. Age > 18 and < 65 years;
5. Performance status (Karnofsky index ¡Ã 80% or WHO ¡Â grade 1);
6. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Pregnant, or lactating patients. Patients of childbearing potential must use adequate contraception;
2. Distant metastases;
3. Clinically evident infection or other serious underlying medical condition not compatible with studies entry, eg. Uncontrolled hypertension, cardiac disease (ischaemia, previous myocardial infarction) within 6 months prior to treatment;
4. LVEF < 50%;
5. History of significant neurological or psychiatric disorders including dementia that would prohibit the understanding and giving of informed consent;
6. Prior history of malignancy other than adequately treated basal cell carcinoma of the skin or in sity carcinoma of the cervix, or current other malignancy;
7. Bilateral breast cancer;
8. Previous chemotherapy, radiotherapy or hormone therapy.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL136 |
| NTR-old | NTR170 |
| Ander register | : N/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |