Trial · NCT03911973
Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers
NCT03911973, Phase 1, Phase 2, Active not recruiting, Kari Wisinski
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers. Trials, record NCT03911973. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03911973
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers
- NCT number
- NCT03911973
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 37 participants, estimated
- Lead sponsor
- Kari Wisinski
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Interventions
- Gedatolisib, Talazoparib
- First posted
- 2019-04-11
- Last updated
- 2024-06-07
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of talazoparib in combination with gedatolisib (Phase I) | 28 days | Determine the recommended Phase 2 dose (RP2D) of talazoparib in combination with gedatolisib in patients with advanced human epidermal growth factor receptor 2 (HER2) negative (triple negative or BRCA1/2 deficient) breast cancer. |
| Primary | Objective Response Rate (ORR) (Phase II) | 24 Months | Calculate ORR, which will include confirmed complete response (CR) + confirmed partial response (PR) determined as per RECIST1.1 on treatment with talazoparib in combination with gedatolisib in patients with BRCA1/2 deficient advanced HER2 negative breast cancer. |
| Secondary | Duration of Response (DOR) | 24 Months | Duration of Response (DoR) on treatment with talazoparib in combination with gedatolisib in all patients (Phase I run-in, Cohort A). DoR is defined as the time that measurement criteria are met for complete or partial response (whichever status is recorded first) until the date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since treatment started). |
| Secondary | Clinical Benefit Rate (CBR) at 16 weeks | 16 Weeks | Clinical Benefit Rate (CBR) at 16 weeks; this will include sum of confirmed complete plus partial responses plus stable disease at 16 weeks on treatment with talazoparib in combination with gedatolisib in patients with BRCA1/2 negative, or unknown, advanced TNBC (Cohort A) by RECIST 1.1. |
| Secondary | Overall Survival | 24 Months | Overall Survival (OS) defined as the time from treatment initiation with talazoparib in combination with gedatolisib until death as a result of any cause in patients with BRCA1/2 negative, or unknown, advanced TNBC (Cohort A). |
| Secondary | Rates of Adverse Events | 24 Months | Rates of adverse events by NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5 on treatment with talazoparib in combination with gedatolisib in patients with BRCA1/2 negative, or unknown, advanced TNBC (Cohorts A). |
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 |
|---|---|
| 40471518 | 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/NCT03911973
GET https://conductscience.org/api/trials/v1/NCT03911973/registered