Trial · NCT06328387
HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer
NCT06328387, Phase 1, Phase 2, Unknown, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer. Trials, record NCT06328387. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06328387
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HCQ+ADC vs ADC in the Treatment of Advanced Breast Cancer
- NCT number
- NCT06328387
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer
- Interventions
- Hydroxychloroquine, Sacituzumab Govitecan, Trastuzumab Deruxtecan
- First posted
- 2024-03-25
- Last updated
- 2024-03-25
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Limiting Toxicity, DLT | 3 weeks | A dose limiting toxicity（DLT）is defined as any of the following-related adverse event(AE) that occurs during the DLT period, graded according to the NCI Common Terminology Criteria for Adverse Events(CTCAE), Version 5.0 |
| Primary | Adverse event, AE | 2 years | Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Primary | Objective Response Rate, ORR | 2 years | the proportion of patients with a tumor volume reduction of ≥30% and a minimum timeframe according to accepted response evaluation criteria (e.g., RECIST version 1.1 in solid tumors), including cases of complete response (CR) and partial response (PR). |
| Secondary | Progression-Free Survival, PFS | 2 years | The time from the beginning of treatment to the progression or death of the patient |
| Secondary | Overall Survival, OS | 4 years | The time from the start of randomization to death due to any cause. |
| Secondary | Clinical Benefit Rate, CBR | 24 weeks after enrollment | Proportion of confirmed complete response, partial response, or stable disease ≥ 24 weeks. |
| Secondary | Disease Control Rate, DCR | 2 years | Proportion of patients with stable or shrinking tumor size--sum of the proportions of complete remission (CR), partial remission (PR) and stable disease (SD). |
| Secondary | The rate of adverse events | up to 24 weeks after enrollment | The probability and severity of adverse reactions were analyzed up to 24 weeks after enrollment |
| Secondary | Quality of life scale score, QoL | 1 year | The quality of life score of patients during treatment was analyzed(FACT-B). Performance Status Rating (PSR) was demonstrated for the FACT-B total score, which is the result of the following subscale scores: SWB (the Social / family Well-Being subscale) , EWB (the Emotional Well-Being subscale), AC (Additional Concerns subscale), PWB (the Physical Well-Being subscale), FWB (the Functional Well-Being subscale) |
| Secondary | Exploration of biomarkers | the first week after the enrollment | Objective to explore the correlation between biomarkers and the ORR. The biomarkers will be test by nest-generation sequence, which include 520 genes and tumor mutation burden, like ERBB2/TP53/PIK3CA/ERBB4/CCND1 and so on. |
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.
Papers11
The papers the trial lists on ClinicalTrials.gov.
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/NCT06328387
GET https://conductscience.org/api/trials/v1/NCT06328387/registered