Trial · NCT03101748
Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer
NCT03101748, Phase 1, Phase 2, Terminated, M.D. Anderson Cancer Center; results first posted 2026-02-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer. Trials, record NCT03101748. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03101748
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neratinib and Paclitaxel With or Without Pertuzumab and Trastuzumab Before Combination Chemotherapy in Treating Patients With Metastatic or Locally Advanced Breast Cancer
- NCT number
- NCT03101748
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 34 participants, actual
- Lead sponsor
- M.D. Anderson Cancer Center
- Conditions
Breast Inflammatory Carcinoma, Locally Advanced Breast Carcinoma, Metastatic Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7
- Interventions
- Cyclophosphamide, Doxorubicin, Laboratory Biomarker Analysis, Neratinib, Paclitaxel, Pertuzumab, Trastuzumab
- First posted
- 2017-04-05
- Last updated
- 2026-02-12
- Results first posted
- 2026-02-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose-Limiting Toxicities (DLTs) During Dose Escalation | From treatment initiation through completion of 2 cycles (approximately 6 weeks) | Dose-limiting toxicities (DLTs) observed during the first two treatment cycles (approximately 6 weeks) among participants receiving escalating doses of neratinib in combination therapy in Cohort I Phase Ib. Participants With ≥1 DLT. |
| Primary | Pathologic Complete Response (pCR) in HER2+ Metastatic or Locally Advanced IBC in Cohort I Phase II | At surgery following completion of neoadjuvant therapy (approximately 18-24 weeks from treatment initiation). | Pathologic complete response (pCR) was defined as no residual invasive cancer in the breast and sampled lymph nodes at surgery (ypT0/Tis, ypN0). The primary analysis was conducted using the intent-to-treat (ITT) population; participants who did not undergo surgery were counted as non-pCR. |
| Primary | Pathologic Complete Response (pCR) in HER2-Negative / HR-Positive IBC in Cohort II | At the time of surgery (mastectomy), following completion of neoadjuvant therapy; approximately 18-24 weeks from treatment initiation. | Pathologic complete response (pCR) was defined as no residual invasive cancer in the breast and sampled lymph nodes at surgery (ypT0/Tis, ypN0). The primary analysis was conducted using the intent-to-treat (ITT) population; participants who did not undergo surgery were counted as non-pCR. |
| Secondary | Event-Free Survival (EFS) Rate at 2 Years | From treatment initiation to 2 years after start of therapy. | Event-free survival (EFS) was defined as the time from treatment initiation to the first occurrence of disease progression, recurrence, or death from any cause. EFS rates at 2 years were estimated using the Kaplan-Meier method; participants without an event were censored at last disease assessment. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Dose-Limiting Toxicities (DLTs) During Dose Escalation | From treatment initiation through completion of 2 cycles (approximately 6 weeks) | No participants enrolled on Cohort 1 Phase Ib Dose Level -1, Cohort 1 Phase Ib Dose Level 2, or Cohort 1 Phase Ib Dose Level 3 | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Pathologic Complete Response (pCR) in HER2+ Metastatic or Locally Advanced IBC in Cohort I Phase II | At surgery following completion of neoadjuvant therapy (approximately 18-24 weeks from treatment initiation). | All patients who initiated protocol treatment were included in the intent-to-treat (ITT) population in Cohort I Phase II. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Pathologic Complete Response (pCR) in HER2-Negative / HR-Positive IBC in Cohort II | At the time of surgery (mastectomy), following completion of neoadjuvant therapy; approximately 18-24 weeks from treatment initiation. | All patients who initiated protocol treatment were included in the intent-to-treat (ITT) population in Cohort II. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Event-Free Survival (EFS) Rate at 2 Years | From treatment initiation to 2 years after start of therapy. | All patients who initiated protocol treatment were included. | percentage of participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Dose-Limiting Toxicities (DLTs) During Dose Escalation | Cohort 1 Phase Ib Dose Level 0 | 0 | Participants | ||
| Dose-Limiting Toxicities (DLTs) During Dose Escalation | Cohort 1 Phase Ib Dose Level 1 | 2 | Participants | ||
| Pathologic Complete Response (pCR) in HER2+ Metastatic or Locally Advanced IBC in Cohort I Phase II | Cohort 1 Phase II | 5 | Participants | ||
| Pathologic Complete Response (pCR) in HER2-Negative / HR-Positive IBC in Cohort II | Cohort II | 1 | Participants | ||
| Event-Free Survival (EFS) Rate at 2 Years | Cohort 1 Phase II | 84.6 | 95% Confidence Interval 67.1 to 100 | percentage of participants | |
| Event-Free Survival (EFS) Rate at 2 Years | Cohort 2 | 68.2 | 95% Confidence Interval 48.6 to 95.7 | percentage of participants |
Source ClinicalTrials.gov
Participant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 Phase Ib Dose Level -1 | 0 | |
| Overall Study | STARTED | Cohort 1 Phase Ib Dose Level 0 | 2 | |
| Overall Study | STARTED | Cohort 1 Phase Ib Dose Level 1 | 2 | |
| Overall Study | STARTED | Cohort 1 Phase Ib Dose Level 2 | 0 | |
| Overall Study | STARTED | Cohort 1 Phase Ib Dose Level 3 | 0 | |
| Overall Study | STARTED | Cohort 1 Phase II | 14 | |
| Overall Study | STARTED | Cohort 2 | 16 | |
| Overall Study | COMPLETED | Cohort 1 Phase Ib Dose Level -1 | 0 | |
| Overall Study | COMPLETED | Cohort 1 Phase Ib Dose Level 0 | 1 | |
| Overall Study | COMPLETED | Cohort 1 Phase Ib Dose Level 1 | 1 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events428
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 | Cohort 1 Phase Ib Dose Level 0 | 0 | 2 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 Phase Ib Dose Level 1 | 0 | 2 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 1 Phase II | 1 | 14 | |
| other | Abdominal pain | Gastrointestinal disorders | Cohort 2 | 1 | 16 | |
| other | Acute Kidney Injury | Renal and urinary disorders | Cohort 1 Phase Ib Dose Level 0 | 0 | 2 | |
| other | Acute Kidney Injury | Renal and urinary disorders | Cohort 1 Phase Ib Dose Level 1 | 0 | 2 | |
| other | Acute Kidney Injury | Renal and urinary disorders | Cohort 1 Phase II | 1 | 14 | |
| other | Acute Kidney Injury | Renal and urinary disorders | Cohort 2 | 0 | 16 | |
| other | Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort 1 Phase Ib Dose Level 0 | 0 | 2 | |
| other | Allergic Rhinitis | Respiratory, thoracic and mediastinal disorders | Cohort 1 Phase Ib Dose Level 1 | 1 | 2 |
1 to 10 of 428Source ClinicalTrials.gov
See all 428 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 Phase Ib Dose Level 0 | 1 | 2 |
| Total, all-cause mortality | Cohort 1 Phase Ib Dose Level 1 | 0 | 2 |
| Total, all-cause mortality | Cohort 1 Phase II | 2 | 14 |
| Total, all-cause mortality | Cohort 2 | 5 | 16 |
| Total, other adverse events | Cohort 1 Phase Ib Dose Level 0 | 2 | 2 |
| Total, other adverse events | Cohort 1 Phase Ib Dose Level 1 | 2 | 2 |
| Total, other adverse events | Cohort 1 Phase II | 14 | 14 |
| Total, other adverse events | Cohort 2 | 16 | 16 |
| Total, serious adverse events | Cohort 1 Phase Ib Dose Level 0 | 1 | 2 |
| Total, serious adverse events | Cohort 1 Phase Ib Dose Level 1 | 1 | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41116969 | DERIVED |
Source PubMed
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/NCT03101748
GET https://conductscience.org/api/trials/v1/NCT03101748/flow?page=2