Trial · NCT01772472
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
NCT01772472, Phase 3, Completed, Hoffmann-La Roche; results first posted 2019-10-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE). Trials, record NCT01772472. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01772472
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Trastuzumab Emtansine Versus Trastuzumab as Adjuvant Therapy in Patients With HER2-Positive Breast Cancer Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Preoperative Therapy (KATHERINE)
- NCT number
- NCT01772472
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,486 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Breast Cancer
- Interventions
- trastuzumab, trastuzumab emtansine
- First posted
- 2013-01-21
- Last updated
- 2025-07-22
- Other registries' IDs
- eudract:2012-002018-37
- Results first posted
- 2019-10-01
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive Disease-free Survival (IDFS) Rate at 3 Years | At Year 3 | IDFS event was defined as the first occurrence of any one of the following events: ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion); ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast); distant recurrence (i.e., evidence of breast cancer in any anatomic site-other than the 2 above-mentioned sites - that has either been histologically confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; death attributable to any cause including breast cancer, non-breast cancer or unknown cause . 3-year IDFS rate in ITT population was estimated using Kaplan Meier (KM) method and the percentage of participants who were event-free 3 years after randomization was estimated. |
| Secondary | IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years | At Year 3 | IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and carcinoma in situ \[CIS\] of any site). IDFS event was defined as outlined in the description for IDFS rate outcome measure (OM) number 1. 3-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated. |
| Secondary | IDFS Including SPNBC Rate at 7 Years | At Year 7 | IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and CIS of any site). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 7-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. |
| Secondary | IDFS Including SPNBC Rate at 8 Years | At Year 8 | IDFS including SPNBC was defined the same way as IDFS but including second primary non breast invasive cancer as an event (with the exception of non-melanoma skin cancers and CIS of any site). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 8-year IDFS including SPNBC rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. |
| Secondary | Disease-free Survival (DFS) Rate at 3 Years | At Year 3 | DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral ductal carcinoma in situ (DCIS). IDFS event was defined as outlined in the description for IDFS rate OM number 1. 3-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 3 years after randomization was estimated. |
| Secondary | DFS Rate at 7 Years | At Year 7 | DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral DCIS. IDFS event was defined as outlined in the description for IDFS rate OM number 1. 7-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. |
| Secondary | DFS Rate at 8 Years | At Year 8 | DFS was defined as the time between randomization and the date of the first occurrence of an IDFS event including SPNBC event or contralateral or ipsilateral DCIS. IDFS event was defined as outlined in the description for IDFS rate OM number 1. 8-year DFS rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. |
| Secondary | Overall Survival (OS) Rate at 5 Years | At Year 5 | OS was defined as the time from randomization to death due to any cause. 5-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 5 years after randomization was estimated. |
| Secondary | OS Rate at 7 Years | At Year 7 | OS was defined as the time from randomization to death due to any cause. 7-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 7 years after randomization was estimated. |
| Secondary | OS Rate at 8 Years | At Year 8 | OS was defined as the time from randomization to death due to any cause. 8-year OS event-free rate in the ITT population was estimated using KM method, and the percentage of participants who were event-free 8 years after randomization was estimated. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Invasive Disease-free Survival (IDFS) Rate at 3 Years | At Year 3 | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | IDFS Rate at 7 Years | At Year 7 | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | IDFS Rate at 8 Years | At Year 8 | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years | At Year 3 | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | IDFS Including SPNBC Rate at 7 Years | At Year 7 | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | IDFS Including SPNBC Rate at 8 Years | At Year 8 | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Disease-free Survival (DFS) Rate at 3 Years | At Year 3 | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | DFS Rate at 7 Years | At Year 7 | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | DFS Rate at 8 Years | At Year 8 | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS) Rate at 5 Years | At Year 5 | ITT population included all participants who were randomized to the study regardless of whether they received any study treatment. | percentage of participants | NUMBER |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group305
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Invasive Disease-free Survival (IDFS) Rate at 3 Years | Trastuzumab | 77.12 | 95% Confidence Interval 73.96 to 80.28 | percentage of participants | |
| Invasive Disease-free Survival (IDFS) Rate at 3 Years | Trastuzumab Emtansine | 88.44 | 95% Confidence Interval 86.07 to 90.81 | percentage of participants | |
| IDFS Rate at 7 Years | Trastuzumab | 67.11 | 95% Confidence Interval 63.53 to 70.68 | percentage of participants | |
| IDFS Rate at 7 Years | Trastuzumab Emtansine | 80.82 | 95% Confidence Interval 77.86 to 83.78 | percentage of participants | |
| IDFS Rate at 8 Years | Trastuzumab | 64.57 | 95% Confidence Interval 60.90 to 68.23 | percentage of participants | |
| IDFS Rate at 8 Years | Trastuzumab Emtansine | 79.11 | 95% Confidence Interval 76.03 to 82.19 | percentage of participants | |
| IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years | Trastuzumab | 76.98 | 95% Confidence Interval 73.82 to 80.15 | percentage of participants | |
| IDFS Including Second Primary Non-breast Cancer (SPNBC) Rate at 3 Years | Trastuzumab Emtansine | 87.87 | 95% Confidence Interval 85.45 to 90.29 | percentage of participants | |
| IDFS Including SPNBC Rate at 7 Years | Trastuzumab | 66.19 | 95% Confidence Interval 62.59 to 69.80 | percentage of participants | |
| IDFS Including SPNBC Rate at 7 Years | Trastuzumab Emtansine | 79.81 | 95% Confidence Interval 76.79 to 82.82 | percentage of participants |
1 to 10 of 305Source ClinicalTrials.gov
See all 305 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Trastuzumab | 743 | |
| Overall Study | STARTED | Trastuzumab Emtansine | 743 | |
| Overall Study | Safety-evaluable (SE) Population | Trastuzumab | 720 | |
| Overall Study | Safety-evaluable (SE) Population | Trastuzumab Emtansine | 740 | |
| Overall Study | COMPLETED | Trastuzumab | 0 | |
| Overall Study | COMPLETED | Trastuzumab Emtansine | 0 | |
| Overall Study | NOT COMPLETED | Trastuzumab | 743 | |
| Overall Study | NOT COMPLETED | Trastuzumab Emtansine | 743 |
Source ClinicalTrials.gov
Adverse events298
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 | Trastuzumab | 60 | 720 | 79 |
| other | ANAEMIA | Blood and lymphatic system disorders | Trastuzumab Emtansine | 74 | 740 | 90 |
| other | LACRIMATION INCREASED | Eye disorders | Trastuzumab | 13 | 720 | 13 |
| other | LACRIMATION INCREASED | Eye disorders | Trastuzumab Emtansine | 41 | 740 | 44 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Trastuzumab | 42 | 720 | 49 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Trastuzumab Emtansine | 55 | 740 | 66 |
| other | CONSTIPATION | Gastrointestinal disorders | Trastuzumab | 59 | 720 | 66 |
| other | CONSTIPATION | Gastrointestinal disorders | Trastuzumab Emtansine | 125 | 740 | 151 |
| other | DIARRHOEA | Gastrointestinal disorders | Trastuzumab | 89 | 720 | 116 |
| other | DIARRHOEA | Gastrointestinal disorders | Trastuzumab Emtansine | 91 | 740 | 117 |
1 to 10 of 298Source ClinicalTrials.gov
See all 298 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Trastuzumab | 126 | 743 |
| Total, all-cause mortality | Trastuzumab Emtansine | 94 | 743 |
| Total, other adverse events | Trastuzumab | 633 | 720 |
| Total, other adverse events | Trastuzumab Emtansine | 719 | 740 |
| Total, serious adverse events | Trastuzumab | 58 | 720 |
| Total, serious adverse events | Trastuzumab Emtansine | 94 | 740 |
Source ClinicalTrials.gov
Papers2
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Trastuzumab vs Trastuzumab Emtansine: Number of Participants With AEs and SAEs Leading to Death | Trial comparisons |
| Trastuzumab vs Trastuzumab Emtansine: Number of Participants Who Discontinued Treatment Due to AEs | Trial comparisons |
| Trastuzumab vs Trastuzumab Emtansine: deaths from any cause | Trial comparisons |
| Trastuzumab vs Trastuzumab Emtansine: 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/NCT01772472
GET https://conductscience.org/api/trials/v1/NCT01772472/registered?page=2