Trial · NCT01358877
A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
NCT01358877, Phase 3, Completed, Hoffmann-La Roche; results first posted 2018-01-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer. Trials, record NCT01358877. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01358877
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pertuzumab in Addition to Chemotherapy and Trastuzumab as Adjuvant Therapy in Participants With Human Epidermal Growth Receptor 2 (HER2)-Positive Primary Breast Cancer
- NCT number
- NCT01358877
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 4,804 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Breast Cancer
- Interventions
- 5-Fluorouracil, Carboplatin, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin, Paclitaxel, Pertuzumab, Placebo, Trastuzumab
- First posted
- 2011-05-24
- Last updated
- 2025-11-28
- Other registries' IDs
- eudract:2010-022902-41
- Results first posted
- 2018-01-05
Source ClinicalTrials.gov
Registered outcomes40
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Invasive Disease-Free Survival (IDFS) Event (Excluding Second Primary Non-Breast Cancer [SPNBC]), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization to the first occurrence of IDFS event (excluding SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | Percentage of participants with IDFS events (excluding SPNBC) is reported. IDFS event was defined as the first occurrence of one of the following events: Ipsilateral invasive breast tumor recurrence (that is \[i.e.\], 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 two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including ductal carcinoma in situ \[DCIS\] and lobular carcinoma in situ \[LCIS\]) and non-melanoma skin cancer were excluded as an event. |
| Primary | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (excluding SPNBC) at 3 years is reported. IDFS event was defined as the first occurrence of 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 two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. |
| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | The Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (excluding SPNBC) at 6, 8, and 10 years are reported. IDFS event was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, or contralateral invasive breast cancer. All SPNBCs and in situ carcinomas (including DCIS and LCIS) and non-melanoma skin cancer were excluded as an event. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free. |
| Secondary | Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | Percentage of participants with IDFS events (including SPNBC) is reported. IDFS-SPNBC event was defined as the first occurrence of 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 two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). |
| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | Kaplan-Meier estimate of the percentage of participants who were IDFS event-free (including SPNBC) at 3 years is reported. IDFS-SPNBC was defined as the first occurrence of 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 two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). |
| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | Kaplan-Meier estimates of the percentage of participants who were IDFS event-free (including SPNBC) at 6, 8, and 10 years are reported. IDFS-SPNBC was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, or SPNBC (with the exception of non-melanoma skin cancers and in situ carcinoma of any site). Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free. |
| Secondary | Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | Percentage of participants with DFS event is reported. DFS event was defined as the first occurrence of 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 two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS. |
| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | Kaplan-Meier estimate of the percentage of participants who were DFS event-free at 3 years is reported. DFS was defined as the first occurrence of 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 two above mentioned sites); death attributable to any cause; contralateral invasive breast cancer; SPNBC or contralateral or ipsilateral DCIS. |
| Secondary | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | Kaplan-Meier estimates of the percentage of participants who were DFS event-free at 6, 8, and 10 years are reported. DFS was defined as the first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, death attributable to any cause, contralateral invasive breast cancer, SPNBC, or contralateral or ipsilateral DCIS. Participants who had not had an event at the time of data analysis were censored at the date last known to be alive and event-free. |
| Secondary | Percentage of Participants Who Died, First Interim Overall Survival Analysis | Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | Percentage of participants who died due to any cause is reported. |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 registered outcomesOutcomes40
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization to the first occurrence of IDFS event (including SPNBC) (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for IDFS event (including SPNBC) at 3 years. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Disease-Free Survival (DFS) Event, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Randomization to the first occurrence of DFS event (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 3 years | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for DFS event at 3 years. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were DFS Event-Free at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | 6, 8, and 10 years | The overall number of participants analyzed is the ITT population. The number analyzed is the number of participants remaining at risk for an event at the time of analysis for each timepoint. | Estimate of percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died, First Interim Overall Survival Analysis | Randomization until death due to any cause (until data cut-off date 19 December 2016; median [range] follow-up: 3.8 [0-4.9] years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Died, Final Overall Survival Analysis | Randomization until death due to any cause (median [range] follow-up: 11.3 [0-12.9] years) | ITT population | percentage of participants | NUMBER |
| SECONDARY | Kaplan-Meier Estimate of the Percentage of Participants Who Were Alive at 3 Years | 3 years | ITT population. The overall number of participants analyzed is the number of participants remaining at risk for death at Year 3. | Estimate of percentage of participants | NUMBER |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 outcomesResults by group636
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Pertuzumab + Trastuzumab + Chemotherapy | 6 Years | 90.56 | 95% Confidence Interval 89.35 to 91.77 | Estimate of percentage of participants |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Placebo + Trastuzumab + Chemotherapy | 6 Years | 87.76 | 95% Confidence Interval 86.40 to 89.13 | Estimate of percentage of participants |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Pertuzumab + Trastuzumab + Chemotherapy | 8 Years | 88.43 | 95% Confidence Interval 87.10 to 89.76 | Estimate of percentage of participants |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Placebo + Trastuzumab + Chemotherapy | 8 Years | 85.76 | 95% Confidence Interval 84.32 to 87.21 | Estimate of percentage of participants |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Pertuzumab + Trastuzumab + Chemotherapy | 10 Years | 87.17 | 95% Confidence Interval 85.77 to 88.57 | Estimate of percentage of participants |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Excluding SPNBC) at 6, 8, and 10 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Placebo + Trastuzumab + Chemotherapy | 10 Years | 83.82 | 95% Confidence Interval 82.29 to 85.36 | Estimate of percentage of participants |
| Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Pertuzumab + Trastuzumab + Chemotherapy | 7.9 | percentage of participants | ||
| Percentage of Participants With IDFS Event (Including SPNBC), as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Placebo + Trastuzumab + Chemotherapy | 9.6 | percentage of participants | ||
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Pertuzumab + Trastuzumab + Chemotherapy | 93.50 | 95% Confidence Interval 92.49 to 94.51 | Estimate of percentage of participants | |
| Kaplan-Meier Estimate of the Percentage of Participants Who Were IDFS Event-Free (Including SPNBC) at 3 Years, as Assessed Using Radiologic, Histologic Examinations or Laboratory Findings | Placebo + Trastuzumab + Chemotherapy | 92.51 | 95% Confidence Interval 91.43 to 93.58 | Estimate of percentage of participants |
1 to 10 of 636Source ClinicalTrials.gov
See all 636 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pertuzumab + Trastuzumab + Chemotherapy | 2,400 | |
| Overall Study | STARTED | Placebo + Trastuzumab + Chemotherapy | 2,404 | |
| Overall Study | Received at Least 1 Dose of Pertuzumab | Pertuzumab + Trastuzumab + Chemotherapy | 2,340 | |
| Overall Study | Received at Least 1 Dose of Pertuzumab | Placebo + Trastuzumab + Chemotherapy | 24 | |
| Overall Study | Received Any Study Treatment Except for Pertuzumab | Pertuzumab + Trastuzumab + Chemotherapy | 38 | |
| Overall Study | Received Any Study Treatment Except for Pertuzumab | Placebo + Trastuzumab + Chemotherapy | 2,367 | |
| Overall Study | Entered Follow-Up | Pertuzumab + Trastuzumab + Chemotherapy | 2,369 | |
| Overall Study | Entered Follow-Up | Placebo + Trastuzumab + Chemotherapy | 2,381 | |
| Overall Study | COMPLETED | Pertuzumab + Trastuzumab + Chemotherapy | 1,361 | |
| Overall Study | COMPLETED | Placebo + Trastuzumab + Chemotherapy | 1,316 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,200
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 | Pertuzumab + Trastuzumab + Chemotherapy | 667 | 2,364 | 833 |
| other | ANAEMIA | Blood and lymphatic system disorders | Placebo + Trastuzumab + Chemotherapy | 567 | 2,405 | 717 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Pertuzumab + Trastuzumab + Chemotherapy | 220 | 2,364 | 484 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Placebo + Trastuzumab + Chemotherapy | 235 | 2,405 | 535 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Pertuzumab + Trastuzumab + Chemotherapy | 592 | 2,364 | 1,039 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Placebo + Trastuzumab + Chemotherapy | 556 | 2,405 | 1,007 |
| other | DRY EYE | Eye disorders | Pertuzumab + Trastuzumab + Chemotherapy | 141 | 2,364 | 146 |
| other | DRY EYE | Eye disorders | Placebo + Trastuzumab + Chemotherapy | 113 | 2,405 | 118 |
| other | LACRIMATION INCREASED | Eye disorders | Pertuzumab + Trastuzumab + Chemotherapy | 312 | 2,364 | 334 |
| other | LACRIMATION INCREASED | Eye disorders | Placebo + Trastuzumab + Chemotherapy | 324 | 2,405 | 347 |
1 to 10 of 1,200Source ClinicalTrials.gov
See all 1,200 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pertuzumab + Trastuzumab + Chemotherapy | 205 | 2,400 |
| Total, all-cause mortality | Placebo + Trastuzumab + Chemotherapy | 247 | 2,404 |
| Total, other adverse events | Pertuzumab + Trastuzumab + Chemotherapy | 2,353 | 2,364 |
| Total, other adverse events | Placebo + Trastuzumab + Chemotherapy | 2,374 | 2,405 |
| Total, serious adverse events | Pertuzumab + Trastuzumab + Chemotherapy | 792 | 2,364 |
| Total, serious adverse events | Placebo + Trastuzumab + Chemotherapy | 686 | 2,405 |
Source ClinicalTrials.gov
Papers11
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pertuzumab + Trastuzumab + Chemotherapy vs Placebo + Trastuzumab + Chemotherapy: deaths from any cause | Trial comparisons |
| Pertuzumab + Trastuzumab + Chemotherapy vs Placebo + Trastuzumab + Chemotherapy: 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/NCT01358877
GET https://conductscience.org/api/trials/v1/NCT01358877/registered?page=2