Trial · NCT05520723
Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED
NCT05520723, Phase 2, Completed, MedSIR
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED. Trials, record NCT05520723. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05520723
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Preventive stRategy for IMMU132-relatED AEs in TNBC or Luminal Breast Cancer- PRIMED
- NCT number
- NCT05520723
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- MedSIR
- Conditions
- Triple Negative Breast Cancer, Breast Cancer, Advanced HR+/HER2- Breast Cancer
- Interventions
- Sacituzumab govitecan, Loperamide, Granulocyte Colony-Stimulating Factor
- First posted
- 2022-08-30
- Last updated
- 2025-12-04
- Other registries' IDs
- eudract:2022-001397-61
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of grade ≥2 diarrhea | Baseline up to end of 2nd cycle (day 42) | The rate of patients with grade ≥ 2 diarrhea is defined as the number of patients with diarrhea grade 2 to 5 the first 2 cycles of treatment by the number of patients in the analysis set per 100. The adverse events will be assessed by the Investigator and with severity determined using defined and graded according CTCAE v.5.0. The adverse events without the severity grade reported will be considered as grade 3. |
| Primary | Incidence of grade ≥3 neutropenia | Baseline up to end of 2nd cycle (day 42) | The rate of patients with grade ≥ 3 neutropenia is defined as the number of patients with neutropenia grade 3 to 5 the first 2 cycles of treatment by the number of patients in the analysis set per 100. The adverse events will be assessed by the Investigator and with severity determined using defined and graded according CTCAE v.5.0. The adverse events without the severity grade reported will be considered as grade 3. |
| Secondary | Incidence of all grades and grade ≥3 diarrhea. | Until EoS (26 months after study initiation) | Adverse events during the study treatment will be coded according with Medical Dictionary for Regulatory Activities (MedDRA). NCI-CTCAE toxicity grades will be utilized for classifying severity. The adverse events without the severity grade reported will be considered as grade 3. |
| Secondary | Incidence of all grades and grade ≥3 neutropenia. | Until EoS (26 months after study initiation) | Adverse events during the study treatment will be coded according with Medical Dictionary for Regulatory Activities (MedDRA). NCI-CTCAE toxicity grades will be utilized for classifying severity. The adverse events without the severity grade reported will be considered as grade 3. |
| Secondary | Incidence of febrile neutropenia and additional adverse events (AEs) as per NCI-CTCAE v.5.0. | Until EoS (26 months after study initiation) | Adverse events during the study treatment will be coded according with Medical Dictionary for Regulatory Activities (MedDRA). NCI-CTCAE toxicity grades will be utilized for classifying severity. The adverse events without the severity grade reported will be considered as grade 3. |
| Secondary | Discontinuation rate | Until EoS (26 months after study initiation) | The discontinuation rate is defined as the proportion of participants discontinued to any cause relative to the number of patients in the analysis set. The reasons for study discontinuation and the period from the treatment initiation to the time of discontinuation will be also reported. |
| Secondary | Dose reduction rate | Until EoS (26 months after study initiation) | The dose reduction rate is defined as the proportion of participants with dose reduction relative to the number of patients in the analysis set. The reasons for dose reduction and the period from the treatment initiation to the time of the first dose reduction will be also reported. |
| Secondary | Objective response rate (ORR) | Until EoS (26 months after study initiation) | Objective response rate is defined as the proportion of participants with complete response or partial response relative to the number of patients in the analysis set. It will be also calculated only for patients with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication, who died, progressed, or dropped out for any reason prior to reaching an objective response will be counted as non-responders in the assessment of ORR. Tumor response will be defined as best response based on local investigator's assessment according to RECIST v1.1. |
| Secondary | Clinical benefit rate (CBR) | Until EoS (26 months after study initiation) | Clinical benefit rate is defined as the proportion of participants with objective response, or stable disease ≥24 weeks relative to the number of patients in the analysis set. Non-complete response/non-progressive disease will be considered as stable disease. Clinical benefit will be also calculated only for patients with measurable disease at baseline. Participants who do not have on-study radiographic tumor re-evaluation, who received anti-tumor treatment other than the study medication, who died, progressed, or dropped out for any reason prior to reaching an objective response, or stable disease ≥24 weeks will be counted as without clinical benefit. Tumor response will be defined as best response based on local investigator's assessment according to RECIST v1.1 (Appendix 2). |
| Secondary | Duration of response (DoR) | Until EoS (26 months after study initiation) | Duration of response is defined as the time from the first documentation of objective tumor response to the first documentation of disease progression, death due to any cause or treatment discontinuation, whichever occurs first. Duration of response will be calculated in patients with objective response as \[the date response ended (i.e., date of PD, death or discontinuation) - first objective response date +1)\]/30.4. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
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/NCT05520723
GET https://conductscience.org/api/trials/v1/NCT05520723/registered