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An international randomized trial in Locally Advanced Breast Cancer comparing 6 courses of neo-adjuvant doxorubicin and cyclophosphamide plus GM-CSF or G-CSF with a split-course administration of 3 neo-adjuvant and 3 adjuvant cycles including either GM-CSF or G-CSF.

An international randomized trial in Locally Advanced Breast Cancer comparing 6 courses of neo-adjuvant doxorubicin and cyclophosphamide plus GM-CSF or G-CSF with a split-course administration of 3 neo-adjuvant and 3 adjuvant cycles including either GM-CSF or G-CSF.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON27543
Enrollment
720
Registered
2005-08-24
Start date
1999-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced breast cancer.

Interventions

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 2-1
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

Sponsors

VU medisch centrum
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Recurrence of disease or all cause mortality (whichever comes first).—

Secondary

MeasureTime frame
1. Disease-free survival; 2. Overall survival; 3. Response rate.—

Contacts

Public ContactH.M. Pinedo

VU University Medical Center, Department of Medical Oncology, 7 Z 186, P.O. Box 7057

hm.pinedo@vumc.nl+31 (0)20 4444342

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)