Trial · NCT01416389
A Study of LY2523355 in Participants With Breast Cancer
NCT01416389, Phase 2, Completed, Eli Lilly and Company; results first posted 2017-12-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of LY2523355 in Participants With Breast Cancer. Trials, record NCT01416389. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01416389
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of LY2523355 in Participants With Breast Cancer
- NCT number
- NCT01416389
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Eli Lilly and Company
- Conditions
- Metastatic Breast Cancer
- Interventions
- LY2523355, ixabepilone, pegfilgrastim, filgrastim
- First posted
- 2011-08-15
- Last updated
- 2019-09-18
- Results first posted
- 2017-12-04
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Tumor Size (CTS) From Baseline to the End of Cycle 2 | Baseline up to end of Cycle 2 (Day 42) | The log ratio of tumor size at Cycle 2 to tumor size at baseline is calculated for each participant, where the tumor size is the sum of the target lesion measurements at each assessment. |
| Secondary | Percentage of Participants Achieving an Overall Response (Overall Response Rate) | Baseline to measured progressive disease or date of death from any cause (up to 423 days) | Overall response rate is the best response of complete response (CR) or partial response (PR) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. Overall response rate is calculated as a total number of participants with CR or PR divided by the total number of participants with measurable disease, multiplied by 100. |
| Secondary | Progression-free Survival (PFS) | Baseline to measured progressive disease or date of death from any cause (up to 423 days) | Progression-free survival (PFS) is the time from the date of randomization to the first date of progressive disease (PD) or death due to any cause, whichever occurs first. PD is as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines, and is defined as an increase of at least 20% in the sum of the diameters of target lesions, taking as reference the smallest sum on study (included baseline sum if that was the smallest on study). In addition, the sum must have demonstrated an absolute increase of at least 5 millimeter (mm) (the appearance of 1 or more new lesions was considered progression). Kaplan-Meier analysis was performed on the observed distribution of PFS. Participants were censored from analysis for the following reasons: lack of disease assessment, lost to follow-up, and further anticancer therapy started. Median PFS is presented. |
| Secondary | Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate) | Baseline to measured progressive disease or date of death from any cause (up to 423 days) | Clinical benefit rate is the proportion of participants who achieve a best response of complete response (CR), partial response (PR), or stable disease (SD) as classified by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1) guidelines. CR is a disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). PR is an at least 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter. SD is neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as progressive disease, taking as reference the smallest sum diameter since treatment started. Clinical benefit rate is calculated as a total number of participants with CR, PR, or SD divided by the total number of participants with measurable disease, multiplied by 100. |
| Secondary | Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 | Cycle 1: Day 1 and Day 3 | Cmax is the maximum plasma concentration of LY2523355 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1. |
| Secondary | Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307 | Cycle 1: Day 1 and Day 3 | Cmax is the maximum plasma concentration of LSN2546307 (metabolite) after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1. |
| Secondary | Pharmacokinetics, Intracycle Accumulation Ration (Ra) of LY2523355 | Cycle 1: Day 1 and Day 3 | The intracycle accumulation ratio (Ra) is defined as the LY2523355 Cmax on Day 3 of Cycle 1 to the LY2523355 Cmax on Day 1 of Cycle 1 after a 1-hour intravenous infusion of LY2523355 on Day 1 and Day 3 of Cycle 1. |
| Other | Percentage of Deaths on Study Through the Follow-up Period | Baseline through end of treatment follow-up (up to 423 days) | The percentage of participants who died through the follow-up period of the study; the cause of death was not captured. A summary of serious and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Tumor Size (CTS) From Baseline to the End of Cycle 2 | Baseline up to end of Cycle 2 (Day 42) | Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone) and who had target lesion measurements at both baseline and the end of Cycle 2. One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis. | log ratio of end of Cycle 2 to baseline | MEAN |
| SECONDARY | Percentage of Participants Achieving an Overall Response (Overall Response Rate) | Baseline to measured progressive disease or date of death from any cause (up to 423 days) | Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis. | percentage of responders | NUMBER |
| SECONDARY | Progression-free Survival (PFS) | Baseline to measured progressive disease or date of death from any cause (up to 423 days) | Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). The total number of participants censored is 7. One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis. | months | MEDIAN |
| SECONDARY | Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate) | Baseline to measured progressive disease or date of death from any cause (up to 423 days) | Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis. | percentage of responders | NUMBER |
| SECONDARY | Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 | Cycle 1: Day 1 and Day 3 | Participants who received 1 dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LY2523355 Cmax on Day 1 and Day 3 of Cycle 1. One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Deaths on Study Through the Follow-up Period | Baseline through end of treatment follow-up (up to 423 days) | Participants who received at least 1 dose of study medication (LY2523355 or ixabepilone). One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2. The dose was subsequently corrected and the participant is included in this analysis. | percentage of participants | NUMBER |
| SECONDARY | Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LSN2546307 | Cycle 1: Day 1 and Day 3 | Participants who received 1 dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LSN2546307 Cmax on Day 1 and Day 3 of Cycle 1.One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis. | nanograms/milliliter (ng/mL) | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetics, Intracycle Accumulation Ration (Ra) of LY2523355 | Cycle 1: Day 1 and Day 3 | Participants who received 1-dose of LY2523355 on Day 1 and Day 3 of Cycle 1 and who have evaluable pharmacokinetic data to enable estimation of the LY2523355 Cmax on Day 1 and Day 3 of Cycle 1. One participant was mistakenly dosed with 6 mg/m\^2/day in Cycle 1 and for 2 doses in Cycle 2, and is not included in this analysis. | unitless ratio | GEOMETRIC_MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Tumor Size (CTS) From Baseline to the End of Cycle 2 | LY2523355 + Pegfilgrastim or Filgrastim | -0.0 | Standard Deviation 0.08 | log ratio of end of Cycle 2 to baseline | |
| Change in Tumor Size (CTS) From Baseline to the End of Cycle 2 | Ixabepilone | -0.1 | Standard Deviation 0.37 | log ratio of end of Cycle 2 to baseline | |
| Percentage of Participants Achieving an Overall Response (Overall Response Rate) | LY2523355 + Pegfilgrastim or Filgrastim | 3.8 | 90% Confidence Interval 0.2 to 17 | percentage of responders | |
| Percentage of Participants Achieving an Overall Response (Overall Response Rate) | Ixabepilone | 7.7 | 90% Confidence Interval 0.4 to 31.6 | percentage of responders | |
| Progression-free Survival (PFS) | LY2523355 + Pegfilgrastim or Filgrastim | 1.71 | 90% Confidence Interval 1.25 to 2.79 | months | |
| Progression-free Survival (PFS) | Ixabepilone | 2.76 | 90% Confidence Interval 1.41 to 4.80 | months | |
| Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate) | LY2523355 + Pegfilgrastim or Filgrastim | 46.2 | 90% Confidence Interval 29.2 to 63.8 | percentage of responders | |
| Percentage of Participants Achieving a Clinical Benefit (Clinical Benefit Rate) | Ixabepilone | 61.5 | 90% Confidence Interval 35.5 to 83.4 | percentage of responders | |
| Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 | LY2523355 | Cycle 1, Day 1 | 161 | Geometric Coefficient of Variation 81 | nanograms/milliliter (ng/mL) |
| Pharmacokinetics, Maximum Plasma Concentration (Cmax) of LY2523355 | LY2523355 | Cycle 1, Day 3 | 150 | Geometric Coefficient of Variation 56 | nanograms/milliliter (ng/mL) |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LY2523355 + Pegfilgrastim or Filgrastim | 26 | |
| Overall Study | STARTED | Ixabepilone | 13 | |
| Overall Study | Received at Least 1 Dose of Study Drug | LY2523355 + Pegfilgrastim or Filgrastim | 26 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Ixabepilone | 13 | |
| Overall Study | COMPLETED | LY2523355 + Pegfilgrastim or Filgrastim | 23 | |
| Overall Study | COMPLETED | Ixabepilone | 13 | |
| Overall Study | NOT COMPLETED | LY2523355 + Pegfilgrastim or Filgrastim | 3 | |
| Overall Study | NOT COMPLETED | Ixabepilone | 0 |
Source ClinicalTrials.gov
Adverse events156
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | LY2523355 + Pegfilgrastim or Filgrastim | 8 | 26 | 8 |
| other | Anaemia | Blood and lymphatic system disorders | Ixabepilone | 1 | 13 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | LY2523355 + Pegfilgrastim or Filgrastim | 3 | 26 | 3 |
| other | Leukopenia | Blood and lymphatic system disorders | Ixabepilone | 1 | 13 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | LY2523355 + Pegfilgrastim or Filgrastim | 1 | 26 | 1 |
| other | Lymphopenia | Blood and lymphatic system disorders | Ixabepilone | 1 | 13 | 1 |
| other | Neutropenia | Blood and lymphatic system disorders | LY2523355 + Pegfilgrastim or Filgrastim | 6 | 26 | 6 |
| other | Neutropenia | Blood and lymphatic system disorders | Ixabepilone | 1 | 13 | 1 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | LY2523355 + Pegfilgrastim or Filgrastim | 3 | 26 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Ixabepilone | 2 | 13 | 2 |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LY2523355 + Pegfilgrastim or Filgrastim | ||
| Total, all-cause mortality | Ixabepilone | ||
| Total, other adverse events | LY2523355 + Pegfilgrastim or Filgrastim | 26 | 26 |
| Total, other adverse events | Ixabepilone | 12 | 13 |
| Total, serious adverse events | LY2523355 + Pegfilgrastim or Filgrastim | 5 | 26 |
| Total, serious adverse events | Ixabepilone | 4 | 13 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| LY2523355 + Pegfilgrastim or Filgrastim vs Ixabepilone: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01416389
GET https://conductscience.org/api/trials/v1/NCT01416389/events?page=2