Trial · NCT01796197
Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa
NCT01796197, Phase 2, Completed, Dana-Farber Cancer Institute; results first posted 2021-09-05
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa. Trials, record NCT01796197. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01796197
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Paclitaxel + Trastuzumab + Pertuzumab as Pre-Op for Inflammatory BrCa
- NCT number
- NCT01796197
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 23 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Breast Cancer
- Interventions
- Trastuzumab, Pertuzumab, Paclitaxel, Doxorubicin, Cyclophosphamide, Mastectomy, Radiation Therapy
- First posted
- 2013-02-21
- Last updated
- 2026-02-05
- Results first posted
- 2021-09-05
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentages of Participants With Pathologic Complete Response | 18 weeks | Pathologic complete response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative treatment. Participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR. |
| Primary | Residual Cancer Burden Rate | 18 Weeks | Residual cancer burden is calculated an then categorized based on the methods described in the following: Symmans WF, Peintinger F, Hatzis C, et al. Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy. J Clin Oncol 2007;25(28): 4414-22. This method uses tumor size, the proportion of that tumor that is invasive carcinoma, the number of axillary lymph nodes containing metastatic carcinoma and the diameter of the largest metastasis in an axillary lymph node. These parameters are combined in a formula that outputs a RCB index. This index is divided into 4 categories: RCB-0, RCB-I, RCB-II, and RCB-III. The previous categories are in order of increasing severity of RCB. |
| Secondary | Number of Participants With Congestive Heart Failure | 1 year and 8 months | Number of participants with clinically significant congestive heart failure (CHF) as determined by established medical practices. |
| Secondary | Median Disease Free Survival | 63 months | Disease-free survival (DFS) is defined for the participants who undergo surgery, as the duration of time from surgery until ipsilateral local-regional, contralateral or distant invasive recurrence or death from any cause; in the absence of an event, DFS will be censored at the date last know alive and free from recurrence. |
| Secondary | Median Time to Treatment Failure | 63 months | Time to treatment failure (TTF) will be defined among all participants, as the duration of time from treatment initiation to a DFS event or progressive disease during preoperative therapy or treatment disease that is not surgically resectable; in the absence of an event, TTF will be censored at the date last know alive and free from recurrence or progression. |
| Secondary | Median Overall Survival | 63 months | Overall survival (OS) will be defined among all participants, as the duration of time from treatment initiation to death from any cause, or is censored at date last known alive. Post-surgery OS will be defined among the participants who undergo surgery, as the duration of time from treatment initiation to death from any cause, or is censored at date last known alive. |
| Secondary | Pathological Complete Response Rate by Intrinsic Subtype | 18 Weeks | Pathologic complete response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative treatment. Participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR. PAM50 analysis was performed on the biopsy specimen taken on day 1. Participants' pCR was tabulated according to the intrinsic subtype and the association of intrinsic subtype (Estrogen receptor 2 - enriched vs. other) with pCR was assessed using Fisher's exact test. |
| Secondary | Residual Disease Rate by Intrinsic Subtype | 18 Weeks | Residual Disease Rate is the percentage of participants who do not achieve Pathologic complete response (pCR) by the end of preoperative treatment. pCR is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative treatment. Residual disease within the breast at time of mastectomy was assessed by microarray analysis. Residual disease rate was reported by intrinsic subtype identified using day 1 RNAseq analysis. |
| Secondary | Predictive Accuracy Rate of Pre-Treatment Versus On-Treatment Tumor Biopsy RNA Sequencing Profiles | 18 Weeks | Tumor RNA expression from pre-treatment (Day 1) and on-treatment (Day 8) biopsies were evaluated to see if the expression profiles had predictive accuracy of pCR. pCR is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative treatment. Participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR. The biopsies were analyzed by differential expression analysis using standard procedures in R package, limma. A predictive Random Forest model was trained using leave-pair-out-cross-validation with the 80 genes most associated with pCR and/or non-pCR. This model gives an accuracy rate, which indicates the percentage of time that the gene profile predicts pCR or non-pCR for both the pre-treatment and on-treatment profiles. An increase in accuracy for the on-treatment profile would indicate an adaptive response within the tumor associated with resistance to HER2 directed therapies. |
| Secondary | Residual Cancer Burden Rate by ctDNA Profile Change | 18 weeks | Residual cancer burden is calculated an then categorized based on the methods described in the following: Symmans WF, Peintinger F, Hatzis C, et al. Measurement of residual breast cancer burden to predict survival after neoadjuvant chemotherapy. J Clin Oncol 2007;25(28): 4414-22. This method uses tumor size, the proportion of that tumor that is invasive carcinoma, the number of axillary lymph nodes containing metastatic carcinoma and the diameter of the largest metastasis in an axillary lymph node. These parameters are combined in a formula that outputs a RCB index. This index is divided into 4 categories: RCB-0, RCB-I, RCB-II, and RCB-III. The previous categories are in order of increasing severity of RCB. Biopsy/blood will be collected on day 1 and day 8 of therapy for analysis of circulating biomarkers, including ctDNA. Associations between change in ctDNA during therapy and residual cancer burden at the time of definitive surgery will be evaluated. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentages of Participants With Pathologic Complete Response | 18 weeks | Subjects evaluable for response. Participants are not being evaluated based on their post-operative treatment option. Two options are provided to the participants in order to best treat them based on the nature of their disease | percentage of participants | NUMBER |
| PRIMARY | Residual Cancer Burden Rate | 18 Weeks | Subjects evaluable for response. Participants are not being evaluated based on their post-operative treatment option. Two options are provided to the participants in order to best treat them based on the nature of their disease | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Congestive Heart Failure | 1 year and 8 months | Participants evaluable for adverse events. Participants are not being evaluated based on their post-operative treatment option. Two options are provided to the participants in order to best treat them based on the nature of their disease. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Median Disease Free Survival | 63 months | Subjects evaluable for response. Participants are not being evaluated based on their post-operative treatment option. Two options are provided to the participants in order to best treat them based on the nature of their disease. | months | MEDIAN |
| SECONDARY | Median Time to Treatment Failure | 63 months | Subjects evaluable for response. Two options are provided to the participants in order to best treat them based on the nature of their disease. | months | MEDIAN |
| SECONDARY | Median Overall Survival | 63 months | Subjects evaluable for response. Two options are provided to the participants in order to best treat them based on the nature of their disease. | months | MEDIAN |
| SECONDARY | Pathological Complete Response Rate by Intrinsic Subtype | 18 Weeks | No samples collected since very few patients had residual disease and sample size would be too small for any meaningful analysis. | ||
| SECONDARY | Residual Disease Rate by Intrinsic Subtype | 18 Weeks | No samples collected since very few patients had residual disease and sample size would be too small for any meaningful analysis. | ||
| SECONDARY | Predictive Accuracy Rate of Pre-Treatment Versus On-Treatment Tumor Biopsy RNA Sequencing Profiles | 18 Weeks | Subjects evaluable for response. Two options are provided to the participants in order to best treat them based on the nature of their disease. | percent accuracy | NUMBER |
| SECONDARY | Residual Cancer Burden Rate by ctDNA Profile Change | 18 weeks | Data was not collected due to a lack of clinical research funding. |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentages of Participants With Pathologic Complete Response | Treatment Arm | 48 | 90% Confidence Interval 29 to 67 | percentage of participants | |
| Residual Cancer Burden Rate | Treatment Arm | RCB-0 | 48 | 90% Confidence Interval 29 to 67 | percentage of participants |
| Residual Cancer Burden Rate | Treatment Arm | RCB-I | 33 | 90% Confidence Interval 17 to 54 | percentage of participants |
| Residual Cancer Burden Rate | Treatment Arm | RCB-II | 5 | 90% Confidence Interval 2 to 21 | percentage of participants |
| Residual Cancer Burden Rate | Treatment Arm | RCB-III | 14 | 90% Confidence Interval 4 to 33 | percentage of participants |
| Number of Participants With Congestive Heart Failure | Treatment Arm | 0 | Participants | ||
| Median Disease Free Survival | Treatment Arm | NA | 95% Confidence Interval NA to NA | months | |
| Median Time to Treatment Failure | Treatment Arm | NA | 95% Confidence Interval NA to NA | months | |
| Median Overall Survival | Treatment Arm | NA | 95% Confidence Interval NA to NA | months | |
| Predictive Accuracy Rate of Pre-Treatment Versus On-Treatment Tumor Biopsy RNA Sequencing Profiles | Treatment Arm | Day 1 Biopsy | 50 | percent accuracy |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Arm | 23 | |
| Overall Study | COMPLETED | Treatment Arm | 21 | |
| Overall Study | NOT COMPLETED | Treatment Arm | 2 |
Source ClinicalTrials.gov
Adverse events112
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 | Anemia | Blood and lymphatic system disorders | Treatment Arm | 5 | 23 | |
| other | Febrile neutropenia | Blood and lymphatic system disorders | Treatment Arm | 3 | 23 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Treatment Arm | 3 | 23 | |
| other | Ear pain | Ear and labyrinth disorders | Treatment Arm | 1 | 23 | |
| other | Ear and labyrinth disorders - Other, specify | Ear and labyrinth disorders | Treatment Arm | 1 | 23 | |
| other | Blurred vision | Eye disorders | Treatment Arm | 4 | 23 | |
| other | Eye disorders - Other, specify | Eye disorders | Treatment Arm | 1 | 23 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment Arm | 2 | 23 | |
| other | Bloating | Gastrointestinal disorders | Treatment Arm | 2 | 23 | |
| other | Cheilitis | Gastrointestinal disorders | Treatment Arm | 1 | 23 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm | 0 | 23 |
| Total, other adverse events | Treatment Arm | 22 | 23 |
| Total, serious adverse events | Treatment Arm | 6 | 23 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35923923 | 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 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/NCT01796197
GET https://conductscience.org/api/trials/v1/NCT01796197/events?page=2