Trial · NCT01319539
MK2206 in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
NCT01319539, Phase 2, Terminated, National Cancer Institute (NCI); results first posted 2017-08-01
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. MK2206 in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer. Trials, record NCT01319539. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01319539
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- MK2206 in Treating Patients With Stage I, Stage II, or Stage III Breast Cancer
- NCT number
- NCT01319539
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
Estrogen Receptor Negative, Estrogen Receptor Positive, HER2/Neu Negative, HER2/Neu Positive, Progesterone Receptor Negative, Progesterone Receptor Positive, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Triple-Negative Breast Carcinoma
- Interventions
- Akt Inhibitor MK2206, Therapeutic Conventional Surgery, Pharmacological Study, Laboratory Biomarker Analysis
- First posted
- 2011-03-21
- Last updated
- 2017-08-30
- Results first posted
- 2017-08-01
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in pAKT Levels | Baseline, 2 weeks (Day 0 - surgery) | This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue). |
| Secondary | Change in pS6 Levels | Baseline, 2 weeks (Day 0 - surgery) | This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue). |
| Secondary | Change in Ki-67 Expression | Baseline, 2 weeks (Day 0 - surgery) | This is designed to evaluate response to therapy - comparing changes within group (example: invasive pre-MK-2206-treated core versus post-MK-2206-treated surgical tissue). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in pAKT Levels | Baseline, 2 weeks (Day 0 - surgery) | Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue. | percentage of cells | MEAN |
| SECONDARY | Change in pS6 Levels | Baseline, 2 weeks (Day 0 - surgery) | Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue. | percentage of cells | MEAN |
| SECONDARY | Change in Ki-67 Expression | Baseline, 2 weeks (Day 0 - surgery) | Of the 12 participants enrolled and received study treatment, there were 7 participants with evaluable matched core and surgical specimen tissue. | percentage of cells | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in pAKT Levels | Treatment (Akt Inhibitor MK2206) | Core | 25 | Standard Deviation 29 | percentage of cells |
| Change in pAKT Levels | Treatment (Akt Inhibitor MK2206) | Surgery | 0 | Standard Deviation 0 | percentage of cells |
| Change in pS6 Levels | Treatment (Akt Inhibitor MK2206) | Core | 41 | Standard Deviation 36 | percentage of cells |
| Change in pS6 Levels | Treatment (Akt Inhibitor MK2206) | Surgery | 31 | Standard Deviation 32 | percentage of cells |
| Change in Ki-67 Expression | Treatment (Akt Inhibitor MK2206) | Core | 13 | Standard Deviation 23 | percentage of cells |
| Change in Ki-67 Expression | Treatment (Akt Inhibitor MK2206) | Surgery | 12 | Standard Deviation 23 | percentage of cells |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Akt Inhibitor MK2206) | 12 | |
| Overall Study | COMPLETED | Treatment (Akt Inhibitor MK2206) | 12 | |
| Overall Study | NOT COMPLETED | Treatment (Akt Inhibitor MK2206) | 0 |
Source ClinicalTrials.gov
Adverse events33
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 | Mucositis, Grade 1 | Gastrointestinal disorders | Treatment (MK2206) Dose Level 200mg | 1 | 4 | |
| other | Mucositis, Grade 1 | Gastrointestinal disorders | Treatment (MK2206) Dose Level 135mg | 0 | 3 | |
| other | Mucositis, Grade 1 | Gastrointestinal disorders | Treatment (MK2206) Dose Level 90mg | 1 | 5 | |
| other | Mucositis, Grade 2 | Gastrointestinal disorders | Treatment (MK2206) Dose Level 200mg | 2 | 4 | |
| other | Mucositis, Grade 2 | Gastrointestinal disorders | Treatment (MK2206) Dose Level 135mg | 0 | 3 | |
| other | Mucositis, Grade 2 | Gastrointestinal disorders | Treatment (MK2206) Dose Level 90mg | 1 | 5 | |
| other | Rash, Grade 2 | Skin and subcutaneous tissue disorders | Treatment (MK2206) Dose Level 200mg | 1 | 4 | |
| other | Rash, Grade 2 | Skin and subcutaneous tissue disorders | Treatment (MK2206) Dose Level 135mg | 0 | 3 | |
| other | Rash, Grade 2 | Skin and subcutaneous tissue disorders | Treatment (MK2206) Dose Level 90mg | 0 | 5 | |
| other | Rash, Grade 3 | Skin and subcutaneous tissue disorders | Treatment (MK2206) Dose Level 200mg | 1 | 4 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (MK2206) Dose Level 200mg | 0 | 4 |
| Total, all-cause mortality | Treatment (MK2206) Dose Level 135mg | 0 | 3 |
| Total, all-cause mortality | Treatment (MK2206) Dose Level 90mg | 0 | 5 |
| Total, other adverse events | Treatment (MK2206) Dose Level 200mg | 4 | 4 |
| Total, other adverse events | Treatment (MK2206) Dose Level 135mg | 3 | 3 |
| Total, other adverse events | Treatment (MK2206) Dose Level 90mg | 5 | 5 |
| Total, serious adverse events | Treatment (MK2206) Dose Level 200mg | 1 | 4 |
| Total, serious adverse events | Treatment (MK2206) Dose Level 135mg | 0 | 3 |
| Total, serious adverse events | Treatment (MK2206) Dose Level 90mg | 1 | 5 |
Source ClinicalTrials.gov
Papers0
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 |
|---|---|---|---|---|---|
| P30CA013330 | Cancer Center Support Grant | STEIDL, ULRICH | ALBERT EINSTEIN COLLEGE OF MEDICINE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
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/NCT01319539
GET https://conductscience.org/api/trials/v1/NCT01319539/events?page=2