No registrations found.
ID
Source
Brief title
Health condition
breast cancer, metastatic, docetaxel; weekly regimen; tolerability; dose reduction; dose delay; quality of life;
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Study objective
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
Study design
Continious SAE monitoring
. The incidence of febrile neutropenia (% of patients) in the three-weekly schedule is estimated to be 15%, if it does not exceed 5% in the weekly schedule, this is considered clinically significant. Likewise, when estimating the percentage of patients treated every 3 weeks requiring dose reduction for any grade 3 or 4 toxicity at 25%, no more than 10% should require dose reduction in the weekly schedule.
Intervention
Docetaxel 100 mg/m2 q 3 wks vs
docetaxel 35 mg/m2 weekly x6 q 8 wks.
Dept Medical Oncology
A.M. Westermann
Meibergdreef
Amsterdam
The Netherlands
0031 (0)20 5669111
Dept Medical Oncology
A.M. Westermann
Meibergdreef
Amsterdam
The Netherlands
0031 (0)20 5669111
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 < 2
7. Adequate liver function defined by:
Single abnormalities :
Total bilirubine < upper normal limits
Transaminases < 3.5x upper normal limits
Alkaline phosphatase < 6x upper normal limits
Combined abnormalities :
If transaminase levels are between 1.5x and 3,5 x upper normal limits and Alkaline phosphatase is between 2.5x and 6x upper normal limits, starting dosage should be reduced with 25%
NOTE : patients with transaminases >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
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 < 1.5 x 109/L
platelets <100 x 109/L
5. Inadequate liver function
defined by:
Total bilirubin > 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1445 |
| NTR-old | NTR1506 |
| Other | : |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |