Trial · NCT06263543
Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
NCT06263543, Phase 2, Recruiting, Reshma L. Mahtani, D.O.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC. Trials, record NCT06263543. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06263543
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sequencing Antibody Drug Conjugates in ER+/HER2 LOW/ULTRA LOW MBC
- NCT number
- NCT06263543
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 75 participants, estimated
- Lead sponsor
- Reshma L. Mahtani, D.O.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Advanced Breast Cancer, Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Low Breast Cancer
- Interventions
- Sacituzumab govitecan
- First posted
- 2024-02-16
- Last updated
- 2026-08-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall response rate (ORR) | 24 months | ORR will be assessed using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST 1.1). ORR is defined as the percentage of participants who received at least one dose of SG and have achieved a complete response (CR) or partial response (PR) as assessed by the local investigator. |
| Secondary | Clinical benefit rate (CBR) | 24 months | CBR will be assessed using RECIST 1.1 and is defined as the percentage of participants who received at least one dose of SG and have achieved CR, PR, or stable disease (SD) as assessed by the local investigator. |
| Secondary | Progression-free survival (PFS) | 30 months | PFS is defined as the duration of time from the date of first treatment until the date of the first radiological progressive disease (PD) per RECIST 1.1 or death from any cause, whichever comes first. |
| Secondary | Overall survival (OS) | 30 months | OS is defined as the duration of time of first treatment until the date of death from any cause. |
| Secondary | Duration of response (DOR) | 30 months | DOR is defined as the duration of time from the date of first response (CR or PR) until the date of the first radiological PD per RECIST 1.1 or death from any cause, whichever comes first. |
| Secondary | Global Quality of Life | 24 months | Global Quality of Life is measured by European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30), a 30-item instrument designed to measure quality of life in individuals with cancer. The items are related to how difficult activities of daily living are, how often treatment or cancer-related symptoms occur and how much they interfere in daily activities and relationships. Each item is scored on a scale of 1 (not at all) to 4 (very much). Higher scores indicate worse quality of life. |
| Secondary | Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) | 30 months | Percent of participants who experienced a treatment-related AE or SAE while on study. |
| Secondary | Laboratory and Vital Sign Abnormalities | 30 months | Percent of participants who experienced a laboratory or vital sign abnormality that was considered clinically significant by the investigator while on study. |
| Secondary | Growth Factor Support | 30 months | Percent of participants who required the use of growth factor support (administered at the discretion of the investigator) while on study. |
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.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32223649 | BACKGROUND |
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/NCT06263543
GET https://conductscience.org/api/trials/v1/NCT06263543/registered