Trial · NCT02101385
Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer
NCT02101385, Phase 2, Completed, Bryan Schneider, MD; results first posted 2023-09-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer. Trials, record NCT02101385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02101385
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer
- NCT number
- NCT02101385
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 193 participants, actual
- Lead sponsor
- Bryan Schneider, MD
- Conditions
- Malignant Neoplasm of Breast, Breast Cancer
- Interventions
- Genomically Directed Monotherapy, Observation/Standard Therapy
- First posted
- 2014-04-02
- Last updated
- 2023-09-28
- Results first posted
- 2023-09-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Two-Year Disease-Free Survival (DFS) | From C1D1 until death or up to a maximum of 24 months. | Two-year disease-free survival (DFS) in participants with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy. The survival probabilities for arm A and arm B were estimated as 2 year disease free survival. DFS is defined as the duration of time from randomization to time of a DFS event, defined as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause. |
| Secondary | Comparison Between Overall Disease-Free Survival | From C1D1 until death or up to a maximum of 58 months | Overall DFS in participants of arm A and B were compared with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy. DFS is defined as the duration of time from randomization to time of a DFS event, defined as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause. |
| Secondary | Comparison Between One Year Disease Free Survival | From C1D1 until death or up to a maximum of 12 months | One year DFS in participants of arm A and B were compared with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy. The survival probabilities for arm A and arm B were estimated as 1 year disease free survival. Disease Free Survival is defined as the duration of time from randomization to time of a DFS event, defined as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause. |
| Secondary | Five-Year Overall Survival (OS) Rate | From C1D1 until death or up to a maximum of 60 months | 5-year overall survival (OS) in participants is determind with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy. Here 5 - year survival probability to compare arms A and B has been reported. Overall Survival is defined as the time from start of treatment to death from any cause. Subjects who are alive are censored at their last visit dates. |
| Secondary | Number of Patients With Adverse Events as a Measure of Safety and Tolerability | From C1D1 until death or up to a maximum of 60 months | The safety and tolerability of the experimental arm A(genomically directed monotherapy) and control arm B(standard therapy) has been assessed using CTCAE v4.0. Number of subjects who had any adverse events or events greater than grade 3 were reported in this outcome measure. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Two-Year Disease-Free Survival (DFS) | From C1D1 until death or up to a maximum of 24 months. | percentage of participants | NUMBER | |
| SECONDARY | Comparison Between Overall Disease-Free Survival | From C1D1 until death or up to a maximum of 58 months | months | MEDIAN | |
| SECONDARY | Comparison Between One Year Disease Free Survival | From C1D1 until death or up to a maximum of 12 months | percentage of participants | NUMBER | |
| SECONDARY | Five-Year Overall Survival (OS) Rate | From C1D1 until death or up to a maximum of 60 months | probability | NUMBER | |
| SECONDARY | Number of Patients With Adverse Events as a Measure of Safety and Tolerability | From C1D1 until death or up to a maximum of 60 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Two-Year Disease-Free Survival (DFS) | Arm A (Genomically Directed Monotherapy) | 56.6 | percentage of participants | ||
| Percentage of Participants With Two-Year Disease-Free Survival (DFS) | Control Arm B (Observation/Standard Therapy) | 62.4 | percentage of participants | ||
| Comparison Between Overall Disease-Free Survival | Arm A (Genomically Directed Monotherapy) | NA | 95% Confidence Interval 16.6 to NA | months | |
| Comparison Between Overall Disease-Free Survival | Control Arm B (Observation/Standard Therapy) | 48.7 | 95% Confidence Interval 20.8 to NA | months | |
| Comparison Between One Year Disease Free Survival | Arm A (Genomically Directed Monotherapy) | 63.5 | percentage of participants | ||
| Comparison Between One Year Disease Free Survival | Control Arm B (Observation/Standard Therapy) | 72.7 | percentage of participants | ||
| Five-Year Overall Survival (OS) Rate | Arm A (Genomically Directed Monotherapy) | 0.52 | probability | ||
| Five-Year Overall Survival (OS) Rate | Control Arm B (Observation/Standard Therapy) | 0.62 | probability | ||
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | Arm A (Genomically Directed Monotherapy) | Number of patients had at least one adverse event of any grade | 65 | Participants | |
| Number of Patients With Adverse Events as a Measure of Safety and Tolerability | Control Arm B (Observation/Standard Therapy) | Number of patients had at least one adverse event of any grade | 34 | Participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Study Treatment | STARTED | Arm A (Genomically Directed Monotherapy) | 71 | |
| Study Treatment | STARTED | Control Arm B (Observation/Standard Therapy) | 122 | |
| Study Treatment | COMPLETED | Arm A (Genomically Directed Monotherapy) | 45 | |
| Study Treatment | COMPLETED | Control Arm B (Observation/Standard Therapy) | 110 | |
| Study Treatment | NOT COMPLETED | Arm A (Genomically Directed Monotherapy) | 26 | |
| Study Treatment | NOT COMPLETED | Control Arm B (Observation/Standard Therapy) | 12 | |
| Follow up | STARTED | Arm A (Genomically Directed Monotherapy) | 70 | |
| Follow up | STARTED | Control Arm B (Observation/Standard Therapy) | 122 | |
| Follow up | COMPLETED | Arm A (Genomically Directed Monotherapy) | 3 | |
| Follow up | COMPLETED | Control Arm B (Observation/Standard Therapy) | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events274
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 | ABDOMINAL PAIN | Gastrointestinal disorders | Arm A (Genomically Directed Monotherapy) | 3 | 71 | 3 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Control Arm B (Observation/Standard Therapy) | 4 | 122 | 4 |
| other | AGITATION | Psychiatric disorders | Arm A (Genomically Directed Monotherapy) | 1 | 71 | 1 |
| other | AGITATION | Psychiatric disorders | Control Arm B (Observation/Standard Therapy) | 0 | 122 | 0 |
| other | ALANINE AMINOTRANSFERASE INCREASED | Investigations | Arm A (Genomically Directed Monotherapy) | 2 | 71 | 2 |
| other | ALANINE AMINOTRANSFERASE INCREASED | Investigations | Control Arm B (Observation/Standard Therapy) | 1 | 122 | 2 |
| other | ALKALINE PHOSPHATASE INCREASED | Investigations | Arm A (Genomically Directed Monotherapy) | 6 | 71 | 7 |
| other | ALKALINE PHOSPHATASE INCREASED | Investigations | Control Arm B (Observation/Standard Therapy) | 0 | 122 | 0 |
| other | ALLERGIC REACTION | Immune system disorders | Arm A (Genomically Directed Monotherapy) | 1 | 71 | 1 |
| other | ALLERGIC REACTION | Immune system disorders | Control Arm B (Observation/Standard Therapy) | 0 | 122 | 0 |
1 to 10 of 274Source ClinicalTrials.gov
See all 274 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A (Genomically Directed Monotherapy) | 22 | 71 |
| Total, all-cause mortality | Control Arm B (Observation/Standard Therapy) | 39 | 122 |
| Total, other adverse events | Arm A (Genomically Directed Monotherapy) | 65 | 71 |
| Total, other adverse events | Control Arm B (Observation/Standard Therapy) | 33 | 122 |
| Total, serious adverse events | Arm A (Genomically Directed Monotherapy) | 2 | 71 |
| Total, serious adverse events | Control Arm B (Observation/Standard Therapy) | 2 | 122 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A (Genomically Directed Monotherapy) vs Control Arm B (Observation/Standard Therapy): deaths from any cause | Trial comparisons |
| Arm A (Genomically Directed Monotherapy) vs Control Arm B (Observation/Standard Therapy): serious adverse events | Trial comparisons |
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/NCT02101385
GET https://conductscience.org/api/trials/v1/NCT02101385/events?page=2