Trial · NCT03473691
Pilot Study of Glembatumumab Vedotin Following Doxorubicin and Cytoxan as Neo-adjuvant Therapy in Gp-NMB-expressing High Risk Triple Negative Breast Cancer
NCT03473691, Early phase 1, Withdrawn, University of Virginia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pilot Study of Glembatumumab Vedotin Following Doxorubicin and Cytoxan as Neo-adjuvant Therapy in Gp-NMB-expressing High Risk Triple Negative Breast Cancer. Trials, record NCT03473691. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03473691
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pilot Study of Glembatumumab Vedotin Following Doxorubicin and Cytoxan as Neo-adjuvant Therapy in Gp-NMB-expressing High Risk Triple Negative Breast Cancer
- NCT number
- NCT03473691
- Status
- Withdrawn
- Phases
- Early phase 1
- Enrollment
- 0 participants, actual
- Lead sponsor
- University of Virginia
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Glembatumumab Vedotin
- First posted
- 2018-03-22
- Last updated
- 2024-12-09
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | Adverse events will be assessed from the time of consent through 30 days after participants complete GV treatment (unless study treatment is stopped for safety or investigator or participant decision, study treatment will last 25-28 weeks) | Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 |
| Primary | Proportion of patients who complete the 4 cycles of GV within 15 weeks of the first dose of GV (without dose limiting adverse events). | Within 4 months of the last patient enrollment | To assess feasibility, the proportion of patients who receive the intended dose within 15 weeks of the first dose will be estimated with an 80% confidence interval. |
| Primary | Number of discontinuations due to AEs | During each participant's study treatment. Unless study treatment is stopped for safety or investigator or participant decision, study treatment will last about 22 weeks. | Adverse events will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Participants that discontinue study treatment because of AEs based on protocol-defined stopping rules will be included. |
| Secondary | Efficacy | 3-6 weeks after last GV infusion for each patient | Rates of pathologic complete response (pCR) following GV therapy |
| Secondary | Growth Differentiation Factor-11 (GDF11) expression in the tumor | Prior to therapy (in the 28 days prior to starting study treatment) and 3-6 weeks after last GV infusion for each patient. | GDF11 expression by immunohistochemistry prior to and following doxorubicin/cyclophosphamide and GV therapy |
| Secondary | Glycoprotein-NMB (gpNMB) expression in the tumor | Prior to therapy (in the 28 days prior to starting study treatment) and 3-6 weeks after last GV infusion for each patient | gpNMB expression by immunohistochemistry prior to and following doxorubicin/cyclophosphamide and GV therapy |
| Other | Peripheral circulating CD8 and CD4 T cell ratio | Prior to therapy (in the 28 days prior to starting study treatment) and at the last treatment with GV (about 22 weeks after starting study treatment). | Blood will be collected in order to assess the proportions of CD8 and CD4 t cells. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 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/NCT03473691
GET https://conductscience.org/api/trials/v1/NCT03473691/registered