Trial · NCT02776917
Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer
NCT02776917, Phase 1, Completed, Barbara Parker, MD; results first posted 2025-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer. Trials, record NCT02776917. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02776917
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Cirmtuzumab and Paclitaxel for Metastatic or Locally Advanced, Unresectable Breast Cancer
- NCT number
- NCT02776917
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 23 participants, actual
- Lead sponsor
- Barbara Parker, MD
- Conditions
- Breast Neoplasms
- Interventions
- Cirmtuzumab + Paclitaxel
- First posted
- 2016-05-18
- Last updated
- 2025-08-07
- Results first posted
- 2025-08-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-limiting Toxicities During the First 4 Weeks of Treatment | Within 4 weeks of starting study treatment | Clinically significant adverse events per CTCAE Version 4.03 at least possibly related to cirmtuzumab or the combination of cirmtuzumab and paclitaxel during the first four weeks of investigational treatment. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events | 55 weeks | Treatment-emergent adverse events beginning from the start of study treatment to 30 days after study treatment completion or start of new anti-cancer therapy. |
| Secondary | Objective Tumor Response Rate | 55 weeks | Response and progression were evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 guidelines. |
| Secondary | Best Tumor Response Rate | 12 months | The proportion of patients that achieve a response of stable disease or better as assessed by RECIST v1.1 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-limiting Toxicities During the First 4 Weeks of Treatment | Within 4 weeks of starting study treatment | participants | NUMBER | |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events | 55 weeks | participants | NUMBER | |
| SECONDARY | Objective Tumor Response Rate | 55 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Best Tumor Response Rate | 12 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Dose-limiting Toxicities During the First 4 Weeks of Treatment | Cirmtuzumab + Paclitaxel | 0 | participants | ||
| Number of Participants With Treatment-emergent Adverse Events | Cirmtuzumab + Paclitaxel | 16 | participants | ||
| Objective Tumor Response Rate | Cirmtuzumab + Paclitaxel | 6 | Participants | ||
| Best Tumor Response Rate | Cirmtuzumab + Paclitaxel | 12 | 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 | Cirmtuzumab + Paclitaxel | 23 | |
| Overall Study | COMPLETED | Cirmtuzumab + Paclitaxel | 16 | |
| Overall Study | NOT COMPLETED | Cirmtuzumab + Paclitaxel | 7 |
Source ClinicalTrials.gov
Adverse events49
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 | Cirmtuzumab + Paclitaxel | 2 | 16 | 3 |
| other | Supraventricular tachycardia | Cardiac disorders | Cirmtuzumab + Paclitaxel | 2 | 16 | 2 |
| other | Blurred vision | Eye disorders | Cirmtuzumab + Paclitaxel | 2 | 16 | 2 |
| other | Dry eye | Eye disorders | Cirmtuzumab + Paclitaxel | 2 | 16 | 2 |
| other | Eye pain | Eye disorders | Cirmtuzumab + Paclitaxel | 2 | 16 | 2 |
| other | Bloating | Gastrointestinal disorders | Cirmtuzumab + Paclitaxel | 2 | 16 | 2 |
| other | Constipation | Gastrointestinal disorders | Cirmtuzumab + Paclitaxel | 9 | 16 | 12 |
| other | Diarrhea | Gastrointestinal disorders | Cirmtuzumab + Paclitaxel | 7 | 16 | 11 |
| other | Dyspepsia | Gastrointestinal disorders | Cirmtuzumab + Paclitaxel | 2 | 16 | 2 |
| other | Gastroesophageal reflux disease | Gastrointestinal disorders | Cirmtuzumab + Paclitaxel | 2 | 16 | 2 |
1 to 10 of 49Source ClinicalTrials.gov
See all 49 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cirmtuzumab + Paclitaxel | 0 | 16 |
| Total, other adverse events | Cirmtuzumab + Paclitaxel | 16 | 16 |
| Total, serious adverse events | Cirmtuzumab + Paclitaxel | 5 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38408999 | 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/NCT02776917
GET https://conductscience.org/api/trials/v1/NCT02776917/events?page=2