Trial · NCT03854903
WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor
NCT03854903, Phase 1, Completed, Georgetown University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor. Trials, record NCT03854903. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03854903
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitor
- NCT number
- NCT03854903
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 19 participants, actual
- Lead sponsor
- Georgetown University
- Conditions
- Metastatic Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Hormone Receptor Positive Breast Cancer
- Interventions
- Palbociclib, Bosutinib, Fulvestrant
- First posted
- 2019-02-26
- Last updated
- 2025-02-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Toxicity of bosutinib when used in combination with palbociclib and fulvestrant in patients with advanced HR+MBC who are refractory to AI and CDK4/6 inhibitors | 1 year | Toxicity of adverse events will be measured via the Common Toxicity Criteria for Adverse Events (CTCAE 4.03) |
| Primary | Incidence of adverse events of bosutinib when used in combination with palbociclib and fulvestrant in patients with advanced HR+MBC who are refractory to AI and CDK4/6 inhibitors | 1 year | Incidence of adverse events will be measured via the Common Toxicity Criteria for Adverse Events (CTCAE 4.03) |
| Primary | Grade of adverse events of bosutinib when used in combination with palbociclib and fulvestrant in patients with advanced HR+MBC who are refractory to AI and CDK4/6 inhibitors | 1 year | Grade of adverse events will be measured via the Common Toxicity Criteria for Adverse Events (CTCAE 4.03) |
| Primary | Maximum Tolerated Doses (MTD) of palbociclib and bosutinib when used in combination with fulvestrant in patients with advanced HR+MBC who are refractory to AI and CDK4/6 inhibitors | 28 days of therapy | This is a 3+3 escalation phase I study. Three patients will be enrolled at each dose cohort and an evaluation of dose escalation will take place after 3 patients have completed 28 days of therapy. If none of the 3 patients has a dose-limiting toxicity, the next cohort will be treated at the next dose level as per the dose escalation schema. At each dose level, if one patient experiences a dose-limiting toxicity, an additional 3 patients will be enrolled. If 2 or more patients experience dose-limiting toxicity in a single cohort (either 2/3 patients, or 2/6 patients in an expanded cohort), the MTD will have been exceeded and dose escalation will stop. |
| Primary | Recommended Phase II Dose (RP2D) of palbociclib and bosutinib when used in combination with fulvestrant in patients with advanced HR+MBC who are refractory to AI and CDK4/6 inhibitors | 1 year | Once the MTD of the combination is reached, the safety data will be analyzed. Dose reduction within patients (individually) is allowed after the 4-week DLT observation period. This phase I trial will inform the RP2D (recommended phase 2 doses of the drugs on the combination). |
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.
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/NCT03854903
GET https://conductscience.org/api/trials/v1/NCT03854903/registered