Open label randomized phase III study of weekly docetaxel and docetaxel every 3 weeks in patients with metastatic breast cancer, resistant to prior chemotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON23238

Enrollment

160

Registered

2008-10-13

Start date

2001-02-01

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

breast cancer, metastatic, docetaxel

Interventions

Docetaxel 100 mg/m2 q 3 wks vs docetaxel 35 mg/m2 weekly x6 q 8 wks.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histologically or cytologically proven breast adenocarcinoma 2. Measurable disease 3. Metastatic progressive breast cancer 4. Previous therapy: anthracycline containing adjuvant and/or first line therapy, unless clear contraindications for anthracycline treatments. No more than 1 line of chemotherapy for metastatic disease 5. Radiotherapy is allowed, no minimum time interval between the end of radiotherapy and study entry , however the irradiated lesion must not be the only lesion to evaluate response 6. Performance status ECOG 3,5 x ULN associated with alkaline phosphatase >6x ULN are not eligible for study 8. Written informed consent given 9. Age >18 years 10. Compliance with follow up requirements

Exclusion criteria

Exclusion criteria: 1. ECOG > 2 2. Prior exposure to taxanes for metastatic disease. 3. Patient who received two or more lines of prior chemotherapy for metastatic disease 4. Inadequate bone marrow function:  neutrophils UNL 6. Concurrent severe and/or co-morbid medical condition. 7. Concurrent treatment with other experimental drugs or clinical trials. 8. Definite contraindications for the use of corticosteroïds. 9. Pregnant or lactating women. 10. Symptomatic peripheral neuropathy > NCIC-CTC grade II 11. Hormonal treatment (prior hormonal treatment allowed)

Design outcomes

Primary

Measure	Time frame
Primary endpoints: Compare the overall safety profile in both arms : Assess the impact of differences in toxicity profiles on the incidence of dose reduction or dose delay due to grade III-IV toxicities during treatment of patients with pre-treated metastatic breast cancer with Taxotere in a weekly or a 3 weekly schedule	—

Secondary

Measure	Time frame
Secondary endpoints: A. Evaluate efficacy criteria in the two arms: - Time to progression - Response rate - Overall survival B. Assess Quality of Life in both arms	—

Contacts

Public ContactA.M. Westermann

AMC Dept Medical Oncology

0031 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)