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


- candidate number4224
- NTR NumberNTR1506
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-okt-2008
- Secondary IDs 
- Public TitleOpen label randomized phase III study of weekly docetaxel and docetaxel every 3 weeks in patients with metastatic breast cancer, resistant to prior chemotherapy
- Scientific TitleOpen label randomized phase III study of weekly docetaxel and docetaxel every 3 weeks in patients with metastatic breast cancer, resistant to prior chemotherapy
- ACRONYMTAX 613
- hypothesisCompare 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
- Healt Condition(s) or Problem(s) studiedBreast cancer, Metastatic breast cancer, Quality of life, Docetaxel
- Inclusion criteria1. 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 criteria1. 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 corticostero´ds.
9. Pregnant or lactating women.
10. Symptomatic peripheral neuropathy > NCIC-CTC grade II
11. Hormonal treatment (prior hormonal treatment allowed)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2001
- planned closingdate1-apr-2006
- Target number of participants160
- InterventionsDocetaxel 100 mg/m2 q 3 wks vs
docetaxel 35 mg/m2 weekly x6 q 8 wks.
- Primary outcomePrimary 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 outcomeSecondary endpoints:
A. Evaluate efficacy criteria in the two arms:
- Time to progression
- Response rate
- Overall survival
B. Assess Quality of Life in both arms
- TimepointsContinious 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.
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. A.M. Westermann
- CONTACT for SCIENTIFIC QUERIESDr. A.M. Westermann
- Sponsor/Initiator Academic Medical Center (AMC), Department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Sanofi-Aventis
- PublicationsN/A
- Brief summary
- Main changes (audit trail)
- RECORD13-okt-2008 - 2-nov-2008


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