Clinical trial · Interventional
Enzastaurin in Combination of Capecitabine to Treat Breast Cancer
A Double-Blind, Randomized, Phase 2 Trial of Capecitabine Plus Enzastaurin Versus Capecitabine Plus Placebo in Patients With Metastatic or Recurrent Breast Cancer Previously Treated With an Anthracycline and a Taxane
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy
Summary
Brief summary (as posted)
The purpose of this study is to determine whether the combination of enzastaurin and capecitabine is more effective than the combination of placebo and capecitabine in treating participants with breast cancer who were previously treated with an anthracycline and a taxane.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| capecitabine | Drug | Capecitabine | ALIAS |
| enzastaurin | Drug | Enzastaurin | ALIAS |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Capecitabine + Enzastaurin
- interventionNames
- Drug: enzastaurin
- Drug: capecitabine
- type
- PLACEBO_COMPARATOR
- label
- Capecitabine + Placebo
- interventionNames
- Drug: placebo
- Drug: capecitabine
Primary outcomes (1)
- measure
- Progression Free Survival (PFS)
- timeFrame
- Randomization to measured progressive disease or death up to 14 months
- description
- PFS was defined as the time from randomization to the first observation of disease progression or death due to any cause. For participants not known to have died as of the data cut-off date and who did not have progressive disease, PFS was censored at the date of last visit with adequate assessment. For participants who received subsequent anticancer therapy (after discontinuation from the study treatment) prior to disease progression or death, PFS was censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Have been diagnosed with metastatic or recurrent breast cancer. * Have been previously treated with both an anthracycline and a taxane. * Have not received more than two prior chemotherapy treatment programs. * Have stopped any antitumoral hormonal treatment before you enroll in this study. * Have a negative pregnancy blood test if menstruating or capable of becoming pregnant. You must use an approved birth control method during the study and for 3 months after stopping study treatment. Exclusion Criteria: * Cannot follow the study procedures (for example, you cannot swallow tablets). * Are receiving another treatment for your cancer. * Have received another experimental drug in the last 4 weeks. * Have had serious heart disease within last 6 months. * Are pregnant or breast-feeding.
References
Publications (1)
- DERIVEDClemons M, Joy AA, Abdulnabi R, Kotliar M, Lynch J, Jordaan JP, Iscoe N, Gelmon K. Phase II, double-blind, randomized trial of capecitabine plus enzastaurin versus capecitabine plus placebo in patients with metastatic or recurrent breast cancer after prior anthracycline and taxane therapy. Breast Cancer Res Treat. 2010 Nov;124(1):177-86. doi: 10.1007/s10549-010-1152-0. Epub 2010 Sep 3. PMID 20814815