Trial · NCT03765983
GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases
NCT03765983, Phase 2, Terminated, Dana-Farber Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases. Trials, record NCT03765983. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03765983
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases
- NCT number
- NCT03765983
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Breast Cancer
- Interventions
- Trastuzumab, GDC-0084
- First posted
- 2018-12-05
- Last updated
- 2026-05-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate in the CNS | Assessed every 2 cycles for the first 4 cycles, and then every 3 cycles thereafter, until CNS progression or initiation of new anticancer therapy, up to ~34 weeks. | Defined as the proportion of patients with partial or complete response in the CNS, per RANO-BM criteria (Complete response \[CR\]: disappearance of all CNS target lesions sustained for at least 4 weeks, no new lesions, no corticosteroids, stable or improved clinically; Partial response \[PR\]: At least 30% decrease in the sum of longest diameter of CNS target lesions, taking as reference the baseline sum, sustained for at least 4 weeks, no new lesions, stable to decreased corticosteroid dose, stable or improved clinically; Progressive disease \[PD\]: At least a 20% increase in the sum of longest diameter of CNS target lesions, taking as reference the smallest sum on study; Stable disease \[SD\]: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of long diameter of CNS target lesions while on study; Objective response = CR+PR) |
| Primary | Correlation Between Inhibition of p-4EBP1 in Resected Brain Tumor Tissue and Intracranial Response in the Corresponding Patient-derived Xenograft (PDX) Models of BCBM | 2 Years | to correlate on-treatment p4EBP1 levels in the resected brain tumor tissue collected from patients to intracranial response to GDC-0084/trastuzumab and survival in the PDX model generated from the same patient |
| Secondary | Clinical Benefit Rate in the CNS | Assessed every 2 cycles for the first 4 cycles, and then every 3 cycles thereafter, until CNS progression or initiation of new anticancer therapy, up to ~34 weeks | Defined as the proportion of participants with CNS response or stable disease in the CNS \>=18 or 24 weeks, per RANO-BM criteria (Complete response \[CR\]: disappearance of all CNS target lesions sustained for at least 4 weeks, no new lesions, no corticosteroids, stable or improved clinically; Partial response \[PR\]: At least 30% decrease in the sum of longest diameter of CNS target lesions, taking as reference the baseline sum, sustained for at least 4 weeks, no new lesions, stable to decreased corticosteroid dose, stable or improved clinically; Progressive disease \[PD\]: At least a 20% increase in the sum of longest diameter of CNS target lesions, taking as reference the smallest sum on study; Stable disease \[SD\]: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum of long diameter of CNS target lesions while on study; Clinical benefit 18 weeks = CR+PR+SD\>=18 weeks; Clinical benefit 24 weeks = CR+PR+SD\>=24 weeks) |
| Secondary | Clinical Benefit Rate in Extra-CNS | Assessed every 2 cycles for the first 4 cycles, and then every 3 cycles thereafter, until CNS progression or initiation of new anticancer therapy, up to ~34 weeks | Defined as the proportion of participants with non-CNS response or stable disease in non-CNS lesions \>=18 or 24 weeks, per RECIST 1.1 criteria (Complete response \[CR\]: Disappearance of all target lesions; Partial response \[PR\]: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum; Progressive disease \[PD\]: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study; Stable disease \[SD\]: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters on study; Clinical benefit 18 weeks = CR+PR+SD\>=18 weeks; Clinical benefit 24 weeks = CR+PR+SD\>=24 weeks) |
| Secondary | Objective Response Rate in Extra-CNS | Assessed every 2 cycles for the first 4 cycles, and then every 3 cycles thereafter, until CNS progression or initiation of new anticancer therapy, up to ~34 weeks. | Defined as the proportion of patients with partial or complete response in non-CNS lesions, per RECIST 1.1 criteria (Complete response \[CR\]: Disappearance of all target lesions; Partial response \[PR\]: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum; Progressive disease \[PD\]: At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study; Stable disease \[SD\]: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters on study; Objective response = CR+PR) |
| Secondary | Duration of CNS Response | Assessed every 2 cycles for the first 4 cycles, and then every 3 cycles thereafter, until CNS progression or initiation of new anticancer therapy, up to ~34 weeks. | Defined as the time measurement criteria are met for CR or PR in the CNS (whichever is first recorded) until the first date that progressive disease is objectively documented |
| Secondary | Bi-compartmental Progression-free Survival | Assessed every 2 cycles for the first 4 cycles, and then every 3 cycles thereafter, until CNS progression or initiation of new anticancer therapy, up to ~34 weeks. | Defined as the time from registration to the first occurrence of progression in the CNS (per RANO-BM criteria), the body (per RECIST 1.1 criteria), or death, whichever comes first. Patients free from progression in the CNS or body are censored at the date of last disease evaluation |
| Secondary | Overall Survival | Assessed every 6 months until death of off-study, up to ~62 months | Defined as the time from registration to death from any cause. Patients still living are censored at the date last known alive |
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 |
|---|---|
| 42895898 | DERIVED |
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/NCT03765983
GET https://conductscience.org/api/trials/v1/NCT03765983/registered