Trial · NCT01966471
A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
NCT01966471, Phase 3, Completed, Hoffmann-La Roche; results first posted 2021-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer. Trials, record NCT01966471. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01966471
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Study of Trastuzumab Emtansine (Kadcyla) Plus Pertuzumab (Perjeta) Following Anthracyclines in Comparison With Trastuzumab (Herceptin) Plus Pertuzumab and a Taxane Following Anthracyclines as Adjuvant Therapy in Participants With Operable HER2-Positive Primary Breast Cancer
- NCT number
- NCT01966471
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,846 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Breast Cancer
- Interventions
- Trastuzumab Emtansine, Trastuzumab, Pertuzumab, Paclitaxel, Epirubicin, Doxorubicin, Docetaxel, Cyclophosphamide, 5-Fluorouracil
- First posted
- 2013-10-21
- Last updated
- 2022-06-14
- Other registries' IDs
- eudract:2012-004902-82
- Results first posted
- 2021-01-12
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation | Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above. | IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population was estimated using the Kaplan-Meier method and estimated the probability of a participant being event-free after 3 years after randomization. |
| Primary | Invasive Disease-Free Survival (IDFS) in the Overall Population | First participant randomized up to approximately 7.5 years | IDFS event was defined as the time from randomization until the date of first occurrence of one of the following: Ipsilateral invasive breast tumor recurrence (an invasive breast cancer \[bc\] involving the same breast parenchyma as the original primary lesion); Ipsilateral local-regional invasive bc recurrence (an invasive bc in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast); Contralateral or ipsilateral second primary invasive bc; Distant recurrence (evidence of bc in any anatomic site \[other than the three sites mentioned above\]) that has either been histologically confirmed or clinically/radiographically diagnosed as recurrent invasive bc; Death attributable to any cause, including bc, non-bc, or unknown cause. 3-year IDFS event-free rate per randomized treatment arms in the ITT population were estimated using the Kaplan-Meier method and estimated the probability of a patient being event-free after 3 years after randomization. |
| Secondary | IDFS Plus Second Primary Non-Breast Cancer | Baseline up to approximately 70 months | IDFS including second primary non-breast cancer was defined the same way as IDFS for the primary endpoint 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). |
| Secondary | Disease-Free Survival (DFS) | Baseline up to approximately 70 months | DFS was defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS). |
| Secondary | Distant Recurrence-Free Interval (DRFI) | Baseline up to approximately 70 months | DRFI was defined as time between randomization and first occurrence of distant breast cancer recurrence. |
| Secondary | Overall Survival (OS) | First participant randomized up to approximately 7.5 years | OS was defined as the time from randomization to death due to any cause. |
| Secondary | Percentage of Participants With Adverse Events | From randomization to approximately 7.5 years | An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events. AEs were reported based on the national cancer institute common terminology criteria for AEs, Version 4.0 (NCI-CTCAE, v4.0). |
| Secondary | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | First participant randomized up to approximately 7.5 years. | LVEF was assessed using either echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans. |
| Secondary | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 | The EORTC QLQ-C30 included global health status, functional scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea/vomiting, and pain) and single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Most questions used a 4-point scale (1 'Not at all' to 4 'Very much'; 2 questions used 7-point scale \[1 'very poor' to 7 'Excellent'\]). Scores were averaged and transformed to 0 - 100 scale, whereby higher scores indicate greater functioning, greater quality of life, or a greater degree of symptoms, with changes of 7 - 15 points considered to be a clinically meaningful detioration to participants. A positive value means an increase, while a negative value means a decrease, in score at the indicated time-point relative to the score at baseline (Cycle 1, Day 1). |
| Secondary | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 | EORTC-QLQ-BR23 is a 23-item breast cancer-specific companion module to the EORTC-QLQ-C30. There are four functional scales (body image, sexual enjoyment, sexual functioning, future perspective \[FP\]) and four symptom scales (systemic side effects \[SE\], upset by hair loss, arm symptoms, breast symptoms). Questions used 4-point scale (1=not at all, 2=a little, 3=quite a bit, 4=very much). Scores averaged and transformed to 0-100 scale. High score for functional scale indicated high/better level of functioning/healthy functioning. Higher scores for symptom scales represent higher levels of symptoms/problems. For functional scales, positive change from baseline indicated improvement in quality of life (QOL) while negative change from baseline indicated a deterioration. For symptom scales, positive change from baseline indicated deterioration and negative change indicated improvement. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
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) in the Node-Positive Subpopulation | Last participant randomized to data cut-off date of 27 November 2019 (approximately 70 months). The 3 year IDFS event-free rate was assessed based on the data collected for each participant considering the cut-off date mentioned above. | The ITT lymph node positive population was a subpopulation of the randomized participant population including patients with positive lymph node. | Percent Probability | NUMBER |
| PRIMARY | Invasive Disease-Free Survival (IDFS) in the Overall Population | First participant randomized up to approximately 7.5 years | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Percent Probability | NUMBER |
| SECONDARY | IDFS Plus Second Primary Non-Breast Cancer | Baseline up to approximately 70 months | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Percent Probability | NUMBER |
| SECONDARY | Disease-Free Survival (DFS) | Baseline up to approximately 70 months | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Percent Probability | NUMBER |
| SECONDARY | Distant Recurrence-Free Interval (DRFI) | Baseline up to approximately 70 months | Percent Probability | NUMBER | |
| SECONDARY | Overall Survival (OS) | First participant randomized up to approximately 7.5 years | The ITT Population comprised all randomized patients, whether or not they received any study treatment or completed a full course of study treatment. Patients were analyzed according to their randomized treatment. | Percent Probability | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events | From randomization to approximately 7.5 years | The safety population included all randomized participants who received at least one full or partial dose of any study treatment. 8 participants were randomized but did not receive any study treatment (5 in the Anthracycline, Trastuzumab, Pertuzumab, and Taxane \[AC-THP\] arm, 3 in the Anthracycline, Trastuzumab Emtansine and Pertuzumab \[AC-KP\] arm). 16 participants in the AC-THP and 13 participants in the AC-KP arm only received AC but no HER2 targeted therapy and were assigned to the AC-THP arm. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Decrease in Left Ventricular Ejection Fraction (LVEF) From Baseline Over Time | First participant randomized up to approximately 7.5 years. | The safety population included all randomized participants who received at least one full or partial dose of any study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Score | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 | The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. The variation of the number of participants in the table reflects the number of participants with corresponding scores at the given visits and at baseline. | Units on a Scale | MEAN |
| SECONDARY | EORTC Quality of Life Questionnaire-Breast Cancer 23 (QLQ-BR23) Score | Baseline, Cycles 1, 2, 3, 4, 5, 9, 14, End of Treatment, Follow-up Month 6, Follow-up Month 12, Follow-up Month 18 | The Patient Reported Outcome (PRO) Population includes participants with both a baseline assessment and at least one post-baseline assessment in any PRO items. The variation of the number of participants in the table reflects the number of participants with corresponding scores at the given visits and at baseline. | Units on a Scale | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group551
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) in the Node-Positive Subpopulation | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 94.10 | 95% Confidence Interval 92.46 to 95.73 | Percent Probability | |
| Invasive Disease-Free Survival (IDFS) in the Node-Positive Subpopulation | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 92.75 | 95% Confidence Interval 90.95 to 94.54 | Percent Probability | |
| Invasive Disease-Free Survival (IDFS) in the Overall Population | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 94.22 | 95% Confidence Interval 92.68 to 95.76 | Percent Probability | |
| Invasive Disease-Free Survival (IDFS) in the Overall Population | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 93.06 | 95% Confidence Interval 91.40 to 94.73 | Percent Probability | |
| IDFS Plus Second Primary Non-Breast Cancer | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 93.43 | 95% Confidence Interval 91.79 to 95.06 | Percent Probability | |
| IDFS Plus Second Primary Non-Breast Cancer | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 92.26 | 95% Confidence Interval 90.51 to 94.02 | Percent Probability | |
| Disease-Free Survival (DFS) | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 93.32 | 95% Confidence Interval 91.67 to 94.97 | Percent Probability | |
| Disease-Free Survival (DFS) | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 92.04 | 95% Confidence Interval 90.26 to 93.81 | Percent Probability | |
| Distant Recurrence-Free Interval (DRFI) | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 95.23 | 95% Confidence Interval 93.82 to 96.64 | Percent Probability | |
| Distant Recurrence-Free Interval (DRFI) | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 94.91 | 95% Confidence Interval 93.46 to 96.36 | Percent Probability |
1 to 10 of 551Source ClinicalTrials.gov
See all 551 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 918 | |
| Overall Study | STARTED | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 928 | |
| Overall Study | COMPLETED | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 0 | |
| Overall Study | COMPLETED | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 0 | |
| Overall Study | NOT COMPLETED | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 918 | |
| Overall Study | NOT COMPLETED | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 928 |
Source ClinicalTrials.gov
Adverse events590
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 | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 184 | 926 | 249 |
| other | Anaemia | Blood and lymphatic system disorders | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 174 | 912 | 243 |
| other | Leukopenia | Blood and lymphatic system disorders | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 73 | 926 | 134 |
| other | Leukopenia | Blood and lymphatic system disorders | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 51 | 912 | 96 |
| other | Neutropenia | Blood and lymphatic system disorders | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 232 | 926 | 411 |
| other | Neutropenia | Blood and lymphatic system disorders | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 220 | 912 | 403 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 25 | 926 | 29 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 162 | 912 | 297 |
| other | Dry eye | Eye disorders | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 62 | 926 | 69 |
| other | Dry eye | Eye disorders | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 75 | 912 | 87 |
1 to 10 of 590Source ClinicalTrials.gov
See all 590 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 45 | 926 |
| Total, all-cause mortality | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 55 | 912 |
| Total, other adverse events | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 902 | 926 |
| Total, other adverse events | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 902 | 912 |
| Total, serious adverse events | Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane | 216 | 926 |
| Total, serious adverse events | Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab | 195 | 912 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34890214 | 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 |
|---|---|
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane vs Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab: deaths from any cause | Trial comparisons |
| Anthracycline Followed by Trastuzumab, Pertuzumab, and Taxane vs Anthracycline Followed by Trastuzumab Emtansine and Pertuzumab: 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.
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