Trial · NCT01097642
Neo-Adjuvant Study in Triple Negative Breast Cancer Patients
NCT01097642, Phase 2, Completed, The Methodist Hospital Research Institute; results first posted 2021-08-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neo-Adjuvant Study in Triple Negative Breast Cancer Patients. Trials, record NCT01097642. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01097642
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neo-Adjuvant Study in Triple Negative Breast Cancer Patients
- NCT number
- NCT01097642
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- The Methodist Hospital Research Institute
- Conditions
- Breast Cancer
- Interventions
- Cetuximab, Ixabepilone
- First posted
- 2010-04-01
- Last updated
- 2021-09-22
- Results first posted
- 2021-08-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate | one year after treatment | The study's primary objective is to determine the pathologic complete response rate (pCR) (breast and axilla) of Ixabepilone versus Ixabepilone when combined with cetuximab in patients with invasive breast adenocarcinoma T1N1-N3M0 or T2-4 N0-3M0 disease who are triple negative and who are candidates for preoperative chemotherapy. The criteria used: "Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate. |
| Secondary | Recurrence Free Survival (RFS) | Median 3-year | The secondary objective is to evaluate the RFS in both treatment groups. The criteria used: "Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate. |
| Secondary | Safety and Toxicity of Both Treatment Regimens: Number of Participants With Adverse Events | one year after last treatment dose | The number of participants with adverse events will be measured. Toxicity/safety will be assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v.3.0). Baseline signs and symptoms will be recorded and followed throughout the trial. Toxicity assessments will be continuous during treatment and the year of follow-up, after which all study drug-related toxicities will be deemed resolved, stabilized, or irreversible. Vital signs will be performed at baseline and will be monitored pre-dose and during study drug administration for Cycles 1 - 4. Chemistry and hematology laboratory tests will be done at baseline and prior to each subsequent chemotherapy cycle. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Response Rate | one year after treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Recurrence Free Survival (RFS) | Median 3-year | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Safety and Toxicity of Both Treatment Regimens: Number of Participants With Adverse Events | one year after last treatment dose | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Response Rate | Ixabepilone | 2 | Participants | ||
| Complete Response Rate | Ixabepilone Plus Cetuximab | 8 | Participants | ||
| Recurrence Free Survival (RFS) | Ixabepilone | 9 | Participants | ||
| Recurrence Free Survival (RFS) | Ixabepilone Plus Cetuximab | 17 | Participants | ||
| Safety and Toxicity of Both Treatment Regimens: Number of Participants With Adverse Events | Ixabepilone | 15 | Participants | ||
| Safety and Toxicity of Both Treatment Regimens: Number of Participants With Adverse Events | Ixabepilone Plus Cetuximab | 25 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ixabepilone | 15 | |
| Overall Study | STARTED | Ixabepilone Plus Cetuximab | 25 | |
| Overall Study | COMPLETED | Ixabepilone | 15 | |
| Overall Study | COMPLETED | Ixabepilone Plus Cetuximab | 25 | |
| Overall Study | NOT COMPLETED | Ixabepilone | 0 | |
| Overall Study | NOT COMPLETED | Ixabepilone Plus Cetuximab | 0 |
Source ClinicalTrials.gov
Adverse events12
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 | Anemia | Blood and lymphatic system disorders | Ixabepilone | 11 | 15 | |
| other | Anemia | Blood and lymphatic system disorders | Ixabepilone Plus Cetuximab | 18 | 25 | |
| other | Fatigue | General disorders | Ixabepilone | 10 | 15 | |
| other | Fatigue | General disorders | Ixabepilone Plus Cetuximab | 21 | 25 | |
| serious | Peripheral neuropathy | Nervous system disorders | Ixabepilone | 2 | 15 | |
| serious | Peripheral neuropathy | Nervous system disorders | Ixabepilone Plus Cetuximab | 2 | 25 | |
| serious | Rash | Skin and subcutaneous tissue disorders | Ixabepilone | 0 | 15 | |
| serious | Rash | Skin and subcutaneous tissue disorders | Ixabepilone Plus Cetuximab | 1 | 25 | |
| serious | GI Events | Gastrointestinal disorders | Ixabepilone | 0 | 15 | |
| serious | GI Events | Gastrointestinal disorders | Ixabepilone Plus Cetuximab | 1 | 25 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ixabepilone | 0 | 15 |
| Total, all-cause mortality | Ixabepilone Plus Cetuximab | 0 | 25 |
| Total, other adverse events | Ixabepilone | 15 | 15 |
| Total, other adverse events | Ixabepilone Plus Cetuximab | 25 | 25 |
| Total, serious adverse events | Ixabepilone | 2 | 15 |
| Total, serious adverse events | Ixabepilone Plus Cetuximab | 6 | 25 |
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 comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ixabepilone vs Ixabepilone Plus Cetuximab: Complete Response Rate | Trial comparisons |
| Ixabepilone vs Ixabepilone Plus Cetuximab: Recurrence Free Survival (RFS) | Trial comparisons |
| Ixabepilone vs Ixabepilone Plus Cetuximab: deaths from any cause | Trial comparisons |
| Ixabepilone vs Ixabepilone Plus Cetuximab: Safety and Toxicity of Both Treatment Regimens: Number of Participants With Adverse Events | Trial comparisons |
| Ixabepilone vs Ixabepilone Plus Cetuximab: serious adverse events | 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/NCT01097642
GET https://conductscience.org/api/trials/v1/NCT01097642/registered