Trial · NCT01147016
Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery
NCT01147016, Phase 2, Terminated, Barbara Ann Karmanos Cancer Institute; results first posted 2023-04-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery. Trials, record NCT01147016. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01147016
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Targeted T Cells After Neoadjuvant Chemotherapy in Treating Women With Stage II or III Breast Cancer Undergoing Surgery
- NCT number
- NCT01147016
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Conditions
- Breast Cancer
- Interventions
- HER2Bi-armed activated T cells, cyclophosphamide, doxorubicin hydrochloride, paclitaxel, laboratory biomarker analysis, neoadjuvant therapy, therapeutic conventional surgery
- First posted
- 2010-06-22
- Last updated
- 2023-04-27
- Results first posted
- 2023-04-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.. | Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesion |
| Secondary | Overall Deaths | From date of randomization until date of death from any cause or end of study, whichever came first, assessed up to 7 years | Total number of deaths |
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 | Progression-free Survival | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 7 years.. | Women with stage II-III, HER2/neu (0-2+) negative breast cancer treated with anti-CD3 x anti-HER2neu (Her2BI) armed, activated T cells after neoadjuvant chemotherapy | months | MEDIAN |
| SECONDARY | Overall Deaths | From date of randomization until date of death from any cause or end of study, whichever came first, assessed up to 7 years | The participant who died had the longest follow-up time. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival | Activated T Cells | 43 | 95% Confidence Interval 2 to NA | months | |
| Overall Deaths | Treated | 1 | 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 | Treated | 8 | |
| Overall Study | COMPLETED | Treated | 8 | |
| Overall Study | NOT COMPLETED | Treated | 0 |
Source ClinicalTrials.gov
Adverse events25
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 | Hypertension | Cardiac disorders | Treated | 1 | 1 | 1 |
| other | chills/rigors | General disorders | Treated | 7 | 8 | 7 |
| other | Nausea | Gastrointestinal disorders | Treated | 7 | 8 | 7 |
| other | Vomiting | Gastrointestinal disorders | Treated | 4 | 8 | 4 |
| other | fatigue | General disorders | Treated | 7 | 8 | 7 |
| other | Rash | General disorders | Treated | 3 | 8 | 3 |
| other | edema | General disorders | Treated | 2 | 8 | 2 |
| other | neuroppathy | Nervous system disorders | Treated | 3 | 8 | 3 |
| other | hypotension | General disorders | Treated | 5 | 8 | 5 |
| other | fever | General disorders | Treated | 6 | 8 | 6 |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treated | 1 | 8 |
| Total, other adverse events | Treated | 8 | 8 |
| Total, serious adverse events | Treated | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA022453 | CANCER CENTER SUPPORT GRANT | PASCHE, BORIS | WAYNE STATE UNIVERSITY | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT01147016
GET https://conductscience.org/api/trials/v1/NCT01147016/events?page=2