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IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Neoplasms

Thank you

Trial Information

IXTEND: A Randomized Phase 2 Study to Evaluate the Combination of Ixabepilone Plus Capecitabine or Capecitabine Plus Docetaxel in the Treatment of Metastatic Breast Cancer

Inclusion Criteria:

- Participants with metastatic breast cancer

- Measurable disease

- Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel
in the neoadjuvant or adjuvant setting acceptable, only if the last dose of
paclitaxel was received 12 months or less before the treatment. There is no timeframe
for prior paclitaxel in the metastatic setting.

- Human epidermal growth factor receptor 2-positive participants allowed if they have
progressed after receiving treatment with trastuzumab or lapatinib

- Eastern Cooperative Oncology Group Performance status of 0-1

- Age younger than 18 years

- Women of childbearing potential must be using an adequate method of contraception to
avoid pregnancy throughout the study and for at least 4 weeks after the last dose of
investigational products

Exclusion Criteria:

- More than 1 chemotherapy regimen for the treatment of metastatic breast cancer

- Prior treatment with any epothilone, capecitabine, or docetaxel

- Prior radiation must not have included 30% or more of major bone marrow-containing
areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum
interval of 2 weeks must be allowed between the last radiation treatment and
administration of study medication. There must be at least 1 week between
focal/palliative radiation and administration of study medication.

- Any current or previous history of brain and/or leptomeningeal metastases

- Neuropathy greater than Grade 2

- Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of
the cervix

- Uncontrolled diabetes mellitus

- Chronic hepatitis

- HIV-positive status

- Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment
for cancer must be discontinued 28 days prior to study medication. Hormonal
anticancer agents must be discontinued at least 14 days prior to study medication.
Hormonal replacement therapy is acceptable

- Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days
before study entry

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Best Tumor Response as Assessed With Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

RECIST definitions: Complete reponse (CR)=disappearance of all nontarget lesions; partial response (PR)=at least 30% reduction in the sum of the longest diameter (LD) of all target lesions in reference to the baseline sum LD; stable disease (SD)=neither PR nor progressive disease (PD) criteria were met; PD=at least 20% increase in the sum of the LD of all target lesions, taking as reference the smallest sum LD recorded at or following baseline. Tumor status assessed by investigator.

Outcome Time Frame:

Baseline to 6 weeks (end of Cycle 2)

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

March 2010

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms



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