Trial · NCT03358017
Neoadjuvant Zoledronate and Atorvastatin in Triple Negative Breast Cancer
NCT03358017, Phase 2, Completed, Mario Negri Institute for Pharmacological Research
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Zoledronate and Atorvastatin in Triple Negative Breast Cancer. Trials, record NCT03358017. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03358017
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Zoledronate and Atorvastatin in Triple Negative Breast Cancer
- NCT number
- NCT03358017
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Mario Negri Institute for Pharmacological Research
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Zoledronate, Atorvastatin 80mg, Standard neoadjuvant cht
- First posted
- 2017-11-30
- Last updated
- 2023-10-19
- Other registries' IDs
- eudract:2016-005112-17
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proof of concept primary activity endpoint - Efficacy endpoint | At surgery, after 6 months of study treatment | Relative reductions of YAP and TAZ IHC-expression at surgery with respect to core-biopsy analysis. |
| Primary | The proportion of responded patients | After 6 months of study treatment | The clinical primary activity endpoint of the second phase of study is the proportion of responder patients, defined as those obtaining a pCR, defined as ypT0ypN0 or as the absence of any residual tumor burden at surgery. |
| Secondary | In relation to high/low p53 levels, relative reductions of YAP and TAZ IHC-expression at surgery with respect to core-biopsy analysis. Efficacy endpoint | At surgery, after 6 months of study treatment | Relative reductions of YAP and TAZ IHC-expression at surgery with respect to core-biopsy analysis according to high/low p53 levels. A high level of p53 is defined by IHC expression ≥30%, while a low level by IHC expression \<30%, as previously described |
| Secondary | Proportion of responder patients according to high/low p53 levels - Efficacy endpoint | After 6 months of study treatment | Proportion of responder patients according to high/low p53 levels |
| Secondary | Disease Free Survival (DFS) - Efficacy endpoint | Date of first recurrence or relapse, second cancer, or death, whichever came first, assessed up to 36 months | Disease free survival (DFS), defined as the time from the date of treatment start to the first of either recurrence or relapse, second cancer, or death, whichever comes first. Subjects alive not having relapse or recurrence or second cancer by the end of the study will be censored at the last disease assessment date. |
| Secondary | Overall survival - Efficacy endpoint | Date of death from any cause, assessed up to 36 months | Overall survival (OS), calculated for each patient as the time from the date of treatment start to the date of death from any cause. Patients not reported as having died at the end of the study will be censored at the date they were last known to be alive. |
| Secondary | Regulation of YAP and TAZ gene expression by RNA-Seq in tumor tissue - Efficacy endpoint | At surgery, after 6 months of study treatment | Proportions of patients with down regulation of YAP and TAZ gene expression by RNA-Seq in tumour tissue collected at definitive surgery with respect to tumour tissue collected at the time of core-biopsy for responder and non-responders patients. |
| Secondary | Relative reduction of Ki67 in tumor samples - Efficacy endpoint | At surgery, after 6 months of study treatment | Relative reduction of Ki67 IHC expression in tumour tissue samples collected at definitive surgery with respect to tumour tissue collected at the time of diagnostic core-biopsy for responder and non-responders patients. |
| Secondary | Study treatment safety - Safety endpoint - AE | From the date of randomization/registration to the end of study, up to 36 months | In order to address the safety endpoint the study will evaluate: \- Incidence, nature, severity and seriousness of AEs, according of National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 |
| Secondary | Study treatment safety - Safety endpoint - Maximum grade | From the date of randomization/registration to the end of study, up to 36 months | In order to address the safety endpoint the study will evaluate: \- Maximum toxicity grade experienced by each patient for each specific toxicity |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
Papers16
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/NCT03358017
GET https://conductscience.org/api/trials/v1/NCT03358017/registered