Trial · NCT02301988
A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
NCT02301988, Phase 2, Completed, Genentech, Inc.; results first posted 2018-09-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer. Trials, record NCT02301988. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02301988
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
- NCT number
- NCT02301988
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 151 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Breast Cancer
- Interventions
- Ipatasertib, Paclitaxel, Placebo
- First posted
- 2014-11-26
- Last updated
- 2018-10-17
- Other registries' IDs
- eudract:2014-003029-16
- Results first posted
- 2018-09-20
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants) | Surgery visit (at approximately Weeks 14 to 19) | pCR was defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer (AJCC) Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes. |
| Primary | Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Have Phosphatase and Tensin Homolog [PTEN]-Low Tumors) | Surgery visit (at approximately Weeks 14 to 19) | pCR was defined by ypT0/Tis ypN0 in the AJCC Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes. |
| Secondary | Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants) | Surgery visit (at approximately Weeks 14 to 19) | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. |
| Secondary | Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Have PTEN-low Tumors) | Surgery visit (at approximately Weeks 14 to 19) | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. |
| Secondary | Percentage of Participants With Objective Tumor Response by Magnetic Resonance Imaging (MRI), As Assessed by Investigator Per the Modified Response Evaluation Criteria in Solid Tumors (RECIST) (in All Participants) | Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16]) | Objective tumor response (OR) was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. OR was the sum of complete response (CR) and partial response (PR). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Percentage of Participants With Objective Tumor Response by MRI, As Assessed by Investigator Per Modified RECIST (in Participants Who Have PTEN-low Tumors) | Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16]) | ORR was based on criteria related to changes in size of target lesions according to modified RECIST. Target lesions were selected on the basis of their size (lesions with the longest diameter) as well as the feasibility of reproducible repeated measurements. ORR was the sum of complete response (CR) and partial response (PR). CR: disappearance of all target lesions. PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. |
| Secondary | Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Diagnostic Positive [Dx+]) | Surgery visit (at approximately Weeks 14 to 19) | pCR was defined by ypT0/Tis ypN0 in the AJCC Staging System with the following determination for breast and axilla by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue and N0: no cancer found in the lymph nodes. |
| Secondary | Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Dx+) | Surgery visit (at approximately Weeks 14 to 19) | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. |
| Secondary | Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype | Surgery visit (at approximately Weeks 14 to 19) | pCR was defined by ypT0/Tis in the AJCC Staging System with the following determination for breast subtypes by local pathology laboratory evaluation: T0: no evidence of primary tumor; Tis: early cancer that has not spread to neighboring tissue. The intrinsic molecular subtypes of breast cancer included here are luminal A (LumA), Her-2, basal-like, normal and unknown. |
| Secondary | Percentage of Participants With Response to Undergoing Breast Conserving Surgery (BCS) Among Participants With T2 or T3 Tumors | Surgery visit (at approximately Weeks 14 to 19) | After neoadjuvant treatment, the number of patients who is appropriate for breast conserving surgery is reported as a measure of efficacy of the treatment to shrink the tumor enough for patients to benefit from less aggressive surgical management. Breast-conserving surgery was defined as removal of part of the breast tissue during surgery. T2 or T3 in the AJCC Staging System were defined as follows: T2: tumor was more than 2 centimeter (cm) but no more than 5 cm across; T3: tumor was larger than 5 cm across. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants) | Surgery visit (at approximately Weeks 14 to 19) | The ITT population included all randomized participants. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Have Phosphatase and Tensin Homolog [PTEN]-Low Tumors) | Surgery visit (at approximately Weeks 14 to 19) | The ITT population included all randomized participants who have PTEN-low tumors. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants) | Surgery visit (at approximately Weeks 14 to 19) | The ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Have PTEN-low Tumors) | Surgery visit (at approximately Weeks 14 to 19) | The ITT population included all randomized participants who have PTEN-low tumors. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Tumor Response by Magnetic Resonance Imaging (MRI), As Assessed by Investigator Per the Modified Response Evaluation Criteria in Solid Tumors (RECIST) (in All Participants) | Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16]) | The ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Objective Tumor Response by MRI, As Assessed by Investigator Per Modified RECIST (in Participants Who Have PTEN-low Tumors) | Screening up to disease progression or death (assessed at screening, pre-surgical visit [approximately Weeks 10-12], early termination visit [up to Week 16]) | The ITT population included all randomized participants who have PTEN-low tumors. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Diagnostic Positive [Dx+]) | Surgery visit (at approximately Weeks 14 to 19) | The ITT population included all randomized participants who are Akt Dx+. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Are Akt Dx+) | Surgery visit (at approximately Weeks 14 to 19) | The ITT population included all randomized participants who are Akt Dx+. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With pCR According to American Joint Committee on Cancer Staging System, by Breast Cancer Subtype | Surgery visit (at approximately Weeks 14 to 19) | The ITT population included all randomized participants. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Response to Undergoing Breast Conserving Surgery (BCS) Among Participants With T2 or T3 Tumors | Surgery visit (at approximately Weeks 14 to 19) | The ITT population included all randomized participants with T2 or T3 Tumors. | percentage of participants | NUMBER |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group36
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 Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants) | Ipatasertib + Paclitaxel | 17.1 | 95% Confidence Interval 9.82 to 27.25 | percentage of participants | |
| Percentage of Participants With Pathological Complete Response (pCR) in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in All Participants) | Placebo + Paclitaxel | 13.3 | 95% Confidence Interval 6.58 to 22.86 | percentage of participants | |
Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Have Phosphatase and Tensin Homolog [PTEN]-Low Tumors) | Ipatasertib + Paclitaxel | 15.8 | 95% Confidence Interval 4.45 to 38.36 | percentage of participants | |
Percentage of Participants With pCR in Breast and Axilla as Defined by ypT0/Tis ypN0 in the American Joint Committee on Cancer Staging System (in Participants Who Have Phosphatase and Tensin Homolog [PTEN]-Low Tumors) | Placebo + Paclitaxel | 12.5 | 95% Confidence Interval 2.27 to 35.43 | percentage of participants | |
| Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants) | Ipatasertib + Paclitaxel | 22.4 | 95% Confidence Interval 14.33 to 33.31 | percentage of participants | |
| Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in All Participants) | Placebo + Paclitaxel | 14.7 | 95% Confidence Interval 7.98 to 24.04 | percentage of participants | |
| Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Have PTEN-low Tumors) | Ipatasertib + Paclitaxel | 15.8 | 95% Confidence Interval 4.45 to 38.36 | percentage of participants | |
| Percentage of Participants With pCR in Breast as Defined by ypT0/Tis in the American Joint Committee on Cancer Staging System (in Participants Who Have PTEN-low Tumors) | Placebo + Paclitaxel | 18.8 | 95% Confidence Interval 5.31 to 42.94 | percentage of participants | |
Percentage of Participants With Objective Tumor Response by Magnetic Resonance Imaging (MRI), As Assessed by Investigator Per the Modified Response Evaluation Criteria in Solid Tumors (RECIST) (in All Participants) | Ipatasertib + Paclitaxel | 67.1 | 95% Confidence Interval 55.86 to 77.46 | percentage of participants | |
Percentage of Participants With Objective Tumor Response by Magnetic Resonance Imaging (MRI), As Assessed by Investigator Per the Modified Response Evaluation Criteria in Solid Tumors (RECIST) (in All Participants) | Placebo + Paclitaxel | 56.0 | 95% Confidence Interval 44.46 to 66.84 | percentage of participants |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ipatasertib + Paclitaxel | 76 | |
| Overall Study | STARTED | Placebo + Paclitaxel | 75 | |
| Overall Study | COMPLETED | Ipatasertib + Paclitaxel | 66 | |
| Overall Study | COMPLETED | Placebo + Paclitaxel | 66 | |
| Overall Study | NOT COMPLETED | Ipatasertib + Paclitaxel | 10 | |
| Overall Study | NOT COMPLETED | Placebo + Paclitaxel | 9 |
Source ClinicalTrials.gov
Adverse events146
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 | Anaemia | Blood and lymphatic system disorders | Ipatasertib + Paclitaxel | 14 | 76 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo + Paclitaxel | 11 | 75 | |
| other | Neutropenia | Blood and lymphatic system disorders | Ipatasertib + Paclitaxel | 7 | 76 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo + Paclitaxel | 6 | 75 | |
| other | Dry eye | Eye disorders | Ipatasertib + Paclitaxel | 3 | 76 | |
| other | Dry eye | Eye disorders | Placebo + Paclitaxel | 4 | 75 | |
| other | Lacrimation increased | Eye disorders | Ipatasertib + Paclitaxel | 4 | 76 | |
| other | Lacrimation increased | Eye disorders | Placebo + Paclitaxel | 1 | 75 | |
| other | Abdominal distension | Gastrointestinal disorders | Ipatasertib + Paclitaxel | 4 | 76 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo + Paclitaxel | 1 | 75 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ipatasertib + Paclitaxel | 1 | 76 |
| Total, all-cause mortality | Placebo + Paclitaxel | 0 | 75 |
| Total, other adverse events | Ipatasertib + Paclitaxel | 76 | 76 |
| Total, other adverse events | Placebo + Paclitaxel | 73 | 75 |
| Total, serious adverse events | Ipatasertib + Paclitaxel | 10 | 76 |
| Total, serious adverse events | Placebo + Paclitaxel | 3 | 75 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31147675 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ipatasertib + Paclitaxel vs Placebo + Paclitaxel: deaths from any cause | Trial comparisons |
| Ipatasertib + Paclitaxel vs Placebo + Paclitaxel: 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/NCT02301988
GET https://conductscience.org/api/trials/v1/NCT02301988/results?page=2