Trial · NCT01036087
Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
NCT01036087, Phase 2, Completed, M.D. Anderson Cancer Center; results first posted 2022-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer. Trials, record NCT01036087. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01036087
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer
- NCT number
- NCT01036087
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 47 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
- Breast Cancer
- Interventions
- Panitumumab, Nab-paclitaxel, Carboplatin, 5-Fluorouracil, Epirubicin, Cyclophosphamide
- First posted
- 2009-12-21
- Last updated
- 2023-03-30
- Results first posted
- 2022-09-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants That Achieved Pathologic Complete Response (CR) | Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment). | Pathologic complete response was defined as absence of invasive carcinoma in the breast, axillary lymph nodes, and skinand absence of tumor emboli within the surgical field. |
| Secondary | Number of Participants With Treatment-related Adverse Events (AEs) | Before each cycle of Panitumumab, nab-paclitaxel and carboplatin (PNC) & fluorouracil, epirubicin and cyclophosphamide (FEC) until 30 days after the last dose of drug, an average of 8 months, unless the participant withdraw consent. | AEs were graded according to the National Cancer Institute's Common Terminology Criteria (CTCAE), version 3.0. All AEs (\>/=2 non-hematological and \>/=3 hematological AEs) occurring after informed consent signing observed by the investigator or reported by the subject whether or not attributed to investigational product. Full AE reporting can be found in the Adverse Event Section. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants That Achieved Pathologic Complete Response (CR) | Assessed after 14 weeks (following PNC and FEC preoperative chemotherapy treatment). | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Treatment-related Adverse Events (AEs) | Before each cycle of Panitumumab, nab-paclitaxel and carboplatin (PNC) & fluorouracil, epirubicin and cyclophosphamide (FEC) until 30 days after the last dose of drug, an average of 8 months, unless the participant withdraw consent. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants That Achieved Pathologic Complete Response (CR) | PNC + FEC | 11 | Participants | ||
| Number of Participants With Treatment-related Adverse Events (AEs) | PNC + FEC | >/=2 non-hematological AEs | 36 | Participants | |
| Number of Participants With Treatment-related Adverse Events (AEs) | PNC + FEC | >/=3 hematological AEs | 26 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PNC + FEC | 40 | |
| Overall Study | COMPLETED | PNC + FEC | 37 | |
| Overall Study | NOT COMPLETED | PNC + FEC | 3 |
Source ClinicalTrials.gov
Adverse events35
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 | Leukopenia | Blood and lymphatic system disorders | PNC + FEC | 9 | 40 | |
| other | Neutrophil count decreased | Blood and lymphatic system disorders | PNC + FEC | 26 | 40 | |
| other | Hemoglobin decreased | Blood and lymphatic system disorders | PNC + FEC | 7 | 40 | |
| other | Platelet count decreased | Blood and lymphatic system disorders | PNC + FEC | 8 | 40 | |
| other | Constipation | Gastrointestinal disorders | PNC + FEC | 6 | 40 | |
| other | Diarrhea | Gastrointestinal disorders | PNC + FEC | 7 | 40 | |
| other | Nausea | Gastrointestinal disorders | PNC + FEC | 16 | 40 | |
| other | Vomiting | Gastrointestinal disorders | PNC + FEC | 5 | 40 | |
| other | Mucositis oral | Gastrointestinal disorders | PNC + FEC | 8 | 40 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | PNC + FEC | 33 | 40 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PNC + FEC | 0 | 40 |
| Total, other adverse events | PNC + FEC | 39 | 40 |
| Total, serious adverse events | PNC + FEC | 15 | 40 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29879283 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01036087
GET https://conductscience.org/api/trials/v1/NCT01036087/events?page=2