Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

Browse trials for

• Breast Neoplasms 12,544

Keywords

• Metastatic Breast Cancer

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 752 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Lead sponsor

R-Pharm is the lead sponsor of 55 studies on the registry; 1 is open to participants now.

Eligibility criteria

Study arms

• Experimental
  A

  Drug: Ixabepilone + Capecitabine

• Active comparator
  B

  Drug: Capecitabine

Interventions

• DrugIxabepilone + Capecitabine

  Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

  Also known as: BMS-247550, IXEMPRA, Epothilone

• DrugCapecitabine

  Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity

Primary outcomes

1. Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)

   PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.

   Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

Secondary outcomes

1. Overall Response Rate (ORR) Per IRRC

   Participants with best response of "Complete" or "Partial" according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions

   Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

2. Duration of Response Per IRRC

   Computed for all patients with a best response of "Partial" or "Complete" per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death.

   Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

3. Time to Response Per IRRC

   Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.

   Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity

4. Overall Survival (OS)

   OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.

   Time frame: from date of randomization until death

5. Treatment-related Safety Summary

   Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0

   Time frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.

6. Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)

   Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.

   Time frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.

Baseline characteristics

3 further baseline measures are reported on the registry.

Publications

• Thomas ES, Gomez HL, Li RK, Chung HC, Fein LE, Chan VF, Jassem J, Pivot XB, Klimovsky JV, de Mendoza FH, Xu B, Campone M, Lerzo GL, Peck RA, Mukhopadhyay P, Vahdat LT, Roche HH. Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol. 2007 Nov 20;25(33):5210-7. doi: 10.1200/JCO.2007.12.6557. Epub 2007 Oct 29. PubMed 17968020 ↗
• Vahdat LT, Vrdoljak E, Gomez H, Li RK, Bosserman L, Sparano JA, Baselga J, Mukhopadhyay P, Valero V. Efficacy and safety of ixabepilone plus capecitabine in elderly patients with anthracycline- and taxane-pretreated metastatic breast cancer. J Geriatr Oncol. 2013 Oct;4(4):346-52. doi: 10.1016/j.jgo.2013.07.006. Epub 2013 Aug 23. PubMed 24472478 ↗
• Jassem J, Fein L, Karwal M, Campone M, Peck R, Poulart V, Vahdat L. Ixabepilone plus capecitabine in advanced breast cancer patients with early relapse after adjuvant anthracyclines and taxanes: a pooled subset analysis of two phase III studies. Breast. 2012 Feb;21(1):89-94. doi: 10.1016/j.breast.2011.09.003. Epub 2011 Sep 21. PubMed 21937232 ↗
• Roche H, Conte P, Perez EA, Sparano JA, Xu B, Jassem J, Peck R, Kelleher T, Hortobagyi GN. Ixabepilone plus capecitabine in metastatic breast cancer patients with reduced performance status previously treated with anthracyclines and taxanes: a pooled analysis by performance status of efficacy and safety data from 2 phase III studies. Breast Cancer Res Treat. 2011 Feb;125(3):755-65. doi: 10.1007/s10549-010-1251-y. Epub 2010 Dec 3. PubMed 21128114 ↗