Trial · NCT03872388
Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy
NCT03872388, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2024-10-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy. Trials, record NCT03872388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03872388
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Atorvastatin in Treating Patients With Stage IIb-III Triple Negative Breast Cancer Who Did Not Achieve a Pathologic Complete Response After Receiving Neoadjuvant Chemotherapy
- NCT number
- NCT03872388
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 6 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Estrogen Receptor Negative, HER2/Neu Negative, Inflammatory Breast Carcinoma, Progesterone Receptor Negative, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma
- Interventions
- Atorvastatin, Capecitabine
- First posted
- 2019-03-13
- Last updated
- 2024-10-02
- Results first posted
- 2024-10-02
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportions of Patients With Undetectable Circulating Tumor Cells (CTC) | At 6 months | Estimate the proportion of patients with undetectable circulating tumor cells (CTCs) at 6 months in patients with stage IIB/III TNBC who did not achieve a pCR or Residual Cancer Burden-I (RCB-I) after receiving neoadjuvant chemotherapy (NAC) with and without atorvastatin therapy. |
| Secondary | Fasting Lipid Profile Level (Low Density Lipoprotein Cholesterol [LDL-C]) and/or Change in Serum Lipid Levels | Baseline up to 2 years | Determine if baseline fasting lipid profile level (LDL-C) and/or change in serum lipid levels are a predictive biomarker of change in the proportion of patients with CTCs. |
| Secondary | Biomarkers on Atorvastatin Treatment Response | Up to 2 years | Assess effect of biomarkers on atorvastatin treatment response, defined as CTCs, circulating tumor DNA (ctDNA), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), serum Interleukin-6 (IL-6) and other inflammatory cytokines, for the purpose of identifying the optimal patient population for future larger scale adjuvant studies. |
| Secondary | Fasting Lipid Profile Level (LDL-C) and 2-year RFS Rate | Baseline up to 2 years | Fasting lipid profile level (LDL-C) and 2-year RFS rate |
| Secondary | Baseline C-reactive Protein (CRP) and/or Change in Serum Lipid Levels | Baseline up to 2 years | Determine if baseline CRP and/or change in serum lipid levels are a predictive biomarker of change in the proportion of patients with CTCs. |
| Secondary | CTCs and 2-year RFS Rate | Baseline up to 2 years | Determine if baseline absolute number of CTCs and/or CTC change are associated with 2-year RFS rate. |
| Secondary | Recurrence-free Survival (RFS) | At 2 years | Estimate the 2-year RFS rate of patients with TNBC who did not achieve pCR with and without atorvastatin therapy. |
| Secondary | Incidence of Adverse Events | Up to 24 months | Adverse events, grade and relationship will be tabulated by treatment arms. |
| Secondary | C-reactive Protein (CRP) and 2-year RFS Rate | Baseline up to 2 years | Determine if baseline C-reactive protein (CRP) and/or change in CRP are associated with 2-year RFS rate. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportions of Patients With Undetectable Circulating Tumor Cells (CTC) | At 6 months | Data were not collected. | ||
| SECONDARY | Fasting Lipid Profile Level (Low Density Lipoprotein Cholesterol [LDL-C]) and/or Change in Serum Lipid Levels | Baseline up to 2 years | Data were not collected. | ||
| SECONDARY | Biomarkers on Atorvastatin Treatment Response | Up to 2 years | Data were not collected. | ||
| SECONDARY | Fasting Lipid Profile Level (LDL-C) and 2-year RFS Rate | Baseline up to 2 years | Data were not collected. | ||
| SECONDARY | Baseline C-reactive Protein (CRP) and/or Change in Serum Lipid Levels | Baseline up to 2 years | Data were not collected. | ||
| SECONDARY | CTCs and 2-year RFS Rate | Baseline up to 2 years | Data were not collected. | ||
| SECONDARY | Recurrence-free Survival (RFS) | At 2 years | Data were not collected. | ||
| SECONDARY | Incidence of Adverse Events | Up to 24 months | Only 1 patient who was treated with atorvastatin came for any follow up appointments, however she missed the 6 month timepoint which is the primary end-point of the study. Therefore she was deemed inevaluable. One other treated patient started treatment and died before the 3 month follow up visit, and hence no data was obtained on any patients for cohort 1-3. | events | NUMBER |
| SECONDARY | C-reactive Protein (CRP) and 2-year RFS Rate | Baseline up to 2 years | Data were not collected. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Adverse Events | Cohort 4a | Grade 1 | 4 | events | |
| Incidence of Adverse Events | Cohort 4b | Grade 1 | 12 | events | |
| Incidence of Adverse Events | Cohort 4a | Grade 2 | 0 | events | |
| Incidence of Adverse Events | Cohort 4b | Grade 2 | 3 | events |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1a | 0 | |
| Overall Study | STARTED | Cohort 1b | 0 | |
| Overall Study | STARTED | Cohort 2a | 0 | |
| Overall Study | STARTED | Cohort 2b | 0 | |
| Overall Study | STARTED | Cohort 3a | 0 | |
| Overall Study | STARTED | Cohort 3b | 0 | |
| Overall Study | STARTED | Cohort 4a | 2 | |
| Overall Study | STARTED | Cohort 4b | 2 | |
| Overall Study | COMPLETED | Cohort 1a | 0 | |
| Overall Study | COMPLETED | Cohort 1b | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events144
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Back Pain | Musculoskeletal and connective tissue disorders | Cohort 1a | 0 | ||
| other | Back Pain | Musculoskeletal and connective tissue disorders | Cohort 1b | 0 | ||
| other | Back Pain | Musculoskeletal and connective tissue disorders | Cohort 2a | 0 | ||
| other | Back Pain | Musculoskeletal and connective tissue disorders | Cohort 2b | 0 | ||
| other | Back Pain | Musculoskeletal and connective tissue disorders | Cohort 3a | 0 | ||
| other | Back Pain | Musculoskeletal and connective tissue disorders | Cohort 3b | 0 | ||
| other | Back Pain | Musculoskeletal and connective tissue disorders | Cohort 4a | 1 | 2 | |
| other | Back Pain | Musculoskeletal and connective tissue disorders | Cohort 4b | 1 | 2 | |
| other | Breast pain | Reproductive system and breast disorders | Cohort 1a | 0 | ||
| other | Breast pain | Reproductive system and breast disorders | Cohort 1b | 0 |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1a | 0 | 0 |
| Total, all-cause mortality | Cohort 1b | 0 | 0 |
| Total, all-cause mortality | Cohort 2a | 0 | 0 |
| Total, all-cause mortality | Cohort 2b | 0 | 0 |
| Total, all-cause mortality | Cohort 3a | 0 | 0 |
| Total, all-cause mortality | Cohort 3b | 0 | 0 |
| Total, all-cause mortality | Cohort 4a | 1 | 2 |
| Total, all-cause mortality | Cohort 4b | 0 | 2 |
| Total, other adverse events | Cohort 1a | 0 | 0 |
| Total, other adverse events | Cohort 1b | 0 | 0 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA016672 | The University of Texas MD Anderson Cancer Center Support Grant (CCSG) | KOONG, ALBERT | UNIVERSITY OF TX MD ANDERSON CAN CTR | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
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/NCT03872388
GET https://conductscience.org/api/trials/v1/NCT03872388/flow?page=2