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A Dose-escalating, Multicenter, Single Arm, Open-Label Study of XRP9881 in Combination With Capecitabine (Xeloda), in Metastatic Breast Cancer Patients With Disease Progressing After Anthracycline and Taxane Therapy

Phase 1/Phase 2
18 Years
Not Enrolling
Breast Cancer, Cancer

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Trial Information

A Dose-escalating, Multicenter, Single Arm, Open-Label Study of XRP9881 in Combination With Capecitabine (Xeloda), in Metastatic Breast Cancer Patients With Disease Progressing After Anthracycline and Taxane Therapy

Inclusion Criteria:

- Histologically or cytologically proven diagnosis of breast adenocarcinoma that is now
metastatic or locally recurrent and inoperable with curative intent.

- Prior treatment with a standard regimen of anthracycline and taxane.

- Female patients at least 18 years old.

- ECOG performance status (PS): 0-2

- Adequate organ and bone marrow function

- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria
(For the part I component, patients with non-measurable disease are accepted.)

- Resolution of all clinically significant toxic effects

- Completion of all prior therapy ≥ 3 weeks prior to registration. Patients on
bisphosphonate therapy may continue such therapy.

- Patients must be either post-menopausal, surgically sterile, or using effective

- Willing and able to comply with study procedures and sign informed consent

Exclusion Criteria:

- History of any second malignancy within the last 5 years (except adequately treated
basal cell or squamous cell skin cancer, or in situ carcinoma of the cervix uteri).

- Patients receiving more than one adjuvant regimen or more than one metastatic regimen

- Known brain or leptomeningeal disease.

- Concurrent treatment on another clinical trial or with any other cancer therapy
including chemotherapy, biological therapy, hormonal therapy, radiotherapy,
chemoembolization therapy, cryotherapy, targeted non-cytotoxic therapies, or patients
planning to receive these treatments during the study.

- Prior treatment with capecitabine, XRP9881, or any investigational chemotherapy.

- History of hypersensitivity to taxanes, Polysorbate-80, or to compounds with similar
chemical structures. Patients with known intolerance to fluoropyrimidines or patients
with known dihydropyrimidine dehydrogenase (DPD) deficiency.

- Concurrent treatment with potent inhibitors of cytochrome P450 3A4, or patients
planning to receive these treatments. For patients who were receiving treatment with
such agents, a one-week washout period is required prior to registration.

- Peripheral neuropathy grade ≥ 2.

- Any of the following within the 6 months prior to registration: myocardial
infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery,
clinically symptomatic and uncontrolled cardiovascular disease, or clinically
significant cardiac arrhythmias (grade 3-4).

- History of inflammatory bowel disease or chronic diarrhea.

- Lack of physical integrity of the upper gastrointestinal tract, malabsorption
syndrome, or inability to take oral medication.

- Other severe acute or chronic medical or psychiatric condition, or significant
laboratory abnormality requiring further investigation or that may cause undue risk
for the patient's safety.

- Known human immunodeficiency virus (HIV) infection requiring treatment or acquired
immunodeficiency-syndrome (AIDS)-related illness.

- Patients who are pregnant or breastfeeding.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety, tolerability, and maximum tolerated dose (MTD) of XRP9881 when given in combination with capecitabine

Outcome Time Frame:

study period

Safety Issue:


Principal Investigator


Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2006

Completion Date:

March 2009

Related Keywords:

  • Breast Cancer
  • Cancer
  • Cancer Alternative Therapies
  • Metastatic Breast Cancer
  • Breast Neoplasms



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