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Weekly Taxol Plus Xeloda® vs Taxotere q3wk Plus Xeloda® in the Treatment of Metastatic BC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00201435
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 20, 2008
Information provided by:
Norwegian Breast Cancer Group

Brief Summary:
We want to compare Taxol given weekly with Taxotere given every 3 week both in comination with Xeloda. We are going to compare time to treatment failure and quality of life.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Drug: Paclitaxel weekly in combination with capecitabine Drug: Docetaxel every 3 week in combination with capecitabine Phase 2 Phase 3

Detailed Description:

Open labeled randomized multicentre phase II/III trial. It is intended to include patients who are not usually included into clinical trials because they are not having disease with measurable lesions. In breast cancer the bulk of patients with metastatic disease is presenting with bone metastases which is difficult to evaluate with respect to response. In this study it is one of the main objectives to include this kind of everyday patients that we see in the clinic.

Because of this we will be using TTF as the primary endpoint. Skeletal events requiring radiotherapy or major changes in pain medications are defined as treatment failures causing stop in treatment even in the absence of radiological findings.

A: weekly Taxol® plus Xeloda® on days 1-14 q 3w B: Taxotere® q 3w plus Xeloda® on days 1-14 q 3w

Patients are randomized equally between the two arms.

Concomitant therapy: Simultaneous use of bisphosphonates is allowed, if this treatment has been initiated at least four weeks before study entry.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weekly Taxol® Plus Xeloda® Versus Taxotere® Every Three Weeks Plus Xeloda® in the Treatment of Metastatic Breast Cancer A Phase II/III Study
Study Start Date : March 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Primary Outcome Measures :
  1. Time to treatment failure
  2. Quality of life

Secondary Outcome Measures :
  1. Response rates
  2. Overall survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria: Morphologically proven breast carcinoma

Written informed patient consent Measurable and/or evaluable disease Measurable disease is defined as least one lesion that can be accurately measured in at least one dimension as ≥20 mm by conventional techniques, or as ≥10 mm by spiral CT scan) as defined in section 8.

Evaluable metastases. Lytic bone metastases as only site of recurrence are allowed and can be evaluated for response according to the WHO-criteria for reporting on response in bone metastases.

Age 18 years or older ECOG Performance Status 0-2 Life expectancy of at least three months Adequate cardiac functions

Adequate hematological, renal and hepatic functions, defined as:

White blood cell count > 3.9 x 109/L Trombocytes > 100 x 109/L Serum creatinine < 1.25 x ULN* Bilirubin < 1.5 ULN If alkaline phosphatases (ALP) is normal ALAT < 3.5 ULN ASAT < 3.5 ULN If alkaline phosphatases (ALP) is > 2.5 ULN ALAT < 1.5 ULN ASAT < 1.5 ULN


Exclusion Criteria: Recurrence-free interval less than one year, if previous adjuvant or neoadjuvant regimen contained a taxane

Neoplasm other than breast carcinoma, except for non-melanoma skin cancer or curatively treated carcinoma in situ of the cervix, diagnosed during the past five years

Pregnancy or lactation

Known brain metastases

Preexisting motor or sensory neuropathy ≥ grade 2 according to NCI CTC 2.0 criteria (severe paresthesia and/or mild weakness, or worse)

Severe hepatic or renal impairment (for capecitabine: calculated creatinine clearance below 30 ml/min; for calculation, see p. 5.1.4) not allowing for adequate use of the proposed regimens

History of known dihydropyrimidine dehydrogenase (DPD) deficiency (severe reaction on previous treatment with fluorouracil)

Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment, including prior allergic reactions to drugs containing cremophor, such as teniposide, cyclosporine or vitamin K

Dementia or significantly altered mental status that would prohibit the understanding and giving of informed consent.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00201435

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Ullevål university hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Norwegian Breast Cancer Group
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Principal Investigator: Erik Wist, MD, PhD
Layout table for additonal information Identifier: NCT00201435    
Other Study ID Numbers: NBCG10
REK 378-04-03133
NMA 03-07568
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 20, 2008
Last Verified: May 2008
Keywords provided by Norwegian Breast Cancer Group:
Qulaity of life
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic