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Trial · NCT07446452

Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study

NCT07446452, Phase 2, Recruiting, The First Affiliated Hospital with Nanjing Medical University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study. Trials, record NCT07446452. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07446452

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Disitamab Vedotin Plus Bevacizumab in HER2-Low Metastatic Breast Cancer After T-DXd Failure: A Phase II Study
NCT number
NCT07446452
Status
Recruiting
Phases
Phase 2
Enrollment
37 participants, estimated
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Conditions
HER2-low Breast Cancer
Interventions
Disitamab Vedotin (RC48), Bevacizumab
First posted
2026-03-03
Last updated
2026-03-03

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryObjective Response Rate (ORR)From first dose until disease progression or death, whichever occurs first, assessed up to 24 months.
SecondaryProgression-Free Survival (PFS)From first dose to the date of radiographically confirmed disease progression or death, whichever occurs first, assessed up to 24 months.
SecondaryDisease Control Rate (DCR)From first dose until disease progression or death, whichever occurs first, assessed up to 24 months.
SecondaryDuration of Response (DOR)From first documented tumor response (CR or PR) until disease progression or death, whichever occurs first, assessed up to 24 months.
SecondaryOverall Survival (OS)From first dose to the date of death from any cause, assessed up to 36 months.
SecondaryNumber of Participants With Treatment-Emergent Adverse Events as Assessed by NCI-CTCAE v5.0From first dose through 90 days after last dose, assessed up to approximately 36 months.
Adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Severity will be graded on a scale of 1 to 5, where 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Life-threatening, and 5 = Death. The number of participants with treatment-emergent adverse events (TEAEs) of any grade will be reported.
SecondaryChange from Baseline in Global Health Status/Quality of Life Score Assessed by EORTC QLQ-C30Assessed at baseline (pre-dose), every 8 weeks during treatment (±7 days), at end of treatment (within 30 days after the last dose), at safety follow-up (Day 90 ±7 days after the last dose).
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) is a 30-item questionnaire used to assess the quality of life of cancer patients. The Global Health Status/Quality of Life (GHS/QoL) scale is derived from 2 specific items within the questionnaire (questions 29 and 30). Scoring: The raw score is transformed to a linear scale ranging from 0 to 100. Interpretation: A higher score indicates a higher ("better") quality of life, while a lower score indicates a lower quality of life.

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT07446452

GET https://conductscience.org/api/trials/v1/NCT07446452/registered