Trial · NCT00976989
A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
NCT00976989, Phase 2, Completed, Hoffmann-La Roche; results first posted 2016-06-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer. Trials, record NCT00976989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00976989
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
- NCT number
- NCT00976989
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 225 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Breast Cancer
- Interventions
- Pertuzumab, Trastuzumab, FEC, Docetaxel, TCH
- First posted
- 2009-09-15
- Last updated
- 2017-02-06
- Other registries' IDs
- eudract:2009-012019-17
- Results first posted
- 2016-06-20
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | From baseline up to approximately 3.5 years | Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events. |
| Primary | Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | From baseline up to approximately 18 weeks | Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of \<50% during the pre-operative (neoadjuvant) period. |
| Secondary | Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | At surgery, after 18 weeks (6 cycles) of treatment | pCR is defined as the absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. pCR is evaluated after 6 cycles of treatment and surgery or following withdrawal from the study whichever occurs sooner. |
| Secondary | Efficacy: Clinical Response Rate | During each 3-week cycle of 6 total cycles: up to 18 weeks | Tumor response is defined as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD) and is identified as per local practice. Clinical response rate is defined as the percentage of participants who achieve a response of CR or PR at any time pre-surgery. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by mammogram or magnetic resonance imaging (MRI) and clinical breast examination (CBE), CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions. |
| Secondary | Efficacy: Time to Clinical Response | Up to 18 weeks | Time to clinical response is defined as the time from the date of first dose received to the first date of assessment of clinical response. Clinical response is defined as a response of CR or PR at any time pre-surgery. Per RECIST v1.0 for target lesions and assessed by mammogram or MRI and CBE, CR is disappearance of all target lesions; PR is \>=30% decrease in the sum of the longest diameter of target lesions. |
| Secondary | Efficacy: Percentage of Participants Achieving Breast Conserving Surgery | At approximately 18 weeks | This is the percentage of participants who achieved breast conserving surgery out of the intent-to-treat population without inflammatory breast cancer, as these participants received mastectomy irrespective of their response to neoadjuvant (pre-operative) treatment. |
| Secondary | Efficacy: Percentage of Participants Without an Overall Survival (OS) Event | From baseline to end of study up to 5 years | Overall survival (OS) was defined as the time from randomization to the date of death from any cause. Participants who were alive or lost to follow-up were censored at the last known alive date. Participants with no post-baseline information were censored at the date of randomization plus one day. |
| Secondary | Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event | From baseline to end of study up to 5 years | The DFS was defined as the time from the first date of no disease (i.e., date of surgery) to the first documentation of progressive disease (PD) or death. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Any evidence of contralateral disease in situ was not considered as PD. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be disease-free. |
| Secondary | Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event | From baseline to end of study up to 5 years | Progression-free survival was defined as the time from the date of randomization to the first documentation of PD or death from any cause, whichever occurred first. PD was assessed using RECIST v1.0 and MRI and CBE. It was defined as at least a 20% increase in the sum of diameters of target lesions with an absolute increase of at least 5 mm or the appearance of one or more new lesions. Participants who were withdrawn from the study without documented PD were censored at the date of the last assessment when the participant was known to be free from PD. Participants without post-baseline assessments but known to be alive were censored at the time of randomization plus one day. |
| Secondary | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years) | Percentage of participants with signs or symptoms of cardiac events. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | From baseline up to approximately 3.5 years | Safety population included all participants who were randomized and received study drug. | percentage of participants | NUMBER |
| PRIMARY | Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | From baseline up to approximately 18 weeks | Safety population included all participants who were randomized and received study drug. | percentage of participants | NUMBER |
| SECONDARY | Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | At surgery, after 18 weeks (6 cycles) of treatment | Intent to treat (ITT) population included all participants who were randomized to treatment. | percentage of participants | NUMBER |
| SECONDARY | Efficacy: Clinical Response Rate | During each 3-week cycle of 6 total cycles: up to 18 weeks | ITT population included all participants who were randomized to treatment. | percentage of participants | NUMBER |
| SECONDARY | Efficacy: Time to Clinical Response | Up to 18 weeks | ITT population included all participants who were randomized to treatment. | weeks | MEDIAN |
| SECONDARY | Efficacy: Percentage of Participants Achieving Breast Conserving Surgery | At approximately 18 weeks | Number of participants analyzed represents the participants with T2-3 tumors for whom mastectomy was planned. | percentage of participants | NUMBER |
| SECONDARY | Efficacy: Percentage of Participants Without an Overall Survival (OS) Event | From baseline to end of study up to 5 years | ITT population included all participants who were randomized to treatment. | percentage of participants | NUMBER |
| SECONDARY | Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event | From baseline to end of study up to 5 years | ITT population included all participants who were randomized to treatment. Number of participants analyzed is total number of participants evaluable during each period. | percentage of participants | NUMBER |
| SECONDARY | Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event | From baseline to end of study up to 5 years | ITT population included all participants who were randomized to treatment. | percentage of participants | NUMBER |
| SECONDARY | Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD) | From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years) | Safety analysis population included all randomized participants who received treatment. Number of participants analyzed is total number of participants evaluable during each period. | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | T+P Concomitant Anthracycline-based Chemotherapy | 0 | percentage of participants | ||
| Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | T+P Sequential Anthracycline-based Chemotherapy | 2.7 | percentage of participants | ||
| Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | T+P Concomitant Non-Anthracycline Chemotherapy | 1.3 | percentage of participants | ||
| Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | T+P Concomitant Anthracycline-based Chemotherapy | 5.6 | percentage of participants | ||
| Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | T+P Sequential Anthracycline-based Chemotherapy | 5.3 | percentage of participants | ||
| Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | T+P Concomitant Non-Anthracycline Chemotherapy | 3.9 | percentage of participants | ||
| Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | T+P Concomitant Anthracycline-based Chemotherapy | 61.6 | 95% Confidence Interval 49.5 to 72.8 | percentage of participants | |
| Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | T+P Sequential Anthracycline-based Chemotherapy | 57.3 | 95% Confidence Interval 45.4 to 68.7 | percentage of participants | |
| Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | T+P Concomitant Non-Anthracycline Chemotherapy | 66.2 | 95% Confidence Interval 54.6 to 76.6 | percentage of participants | |
| Efficacy: Clinical Response Rate | T+P Concomitant Anthracycline-based Chemotherapy | 91.8 | percentage of participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | T+P Concomitant Anthracycline-based Chemotherapy | 73 | |
| Overall Study | STARTED | T+P Sequential Anthracycline-based Chemotherapy | 75 | |
| Overall Study | STARTED | T+P Concomitant Non-Anthracycline Chemotherapy | 77 | |
| Overall Study | COMPLETED | T+P Concomitant Anthracycline-based Chemotherapy | 60 | |
| Overall Study | COMPLETED | T+P Sequential Anthracycline-based Chemotherapy | 63 | |
| Overall Study | COMPLETED | T+P Concomitant Non-Anthracycline Chemotherapy | 60 | |
| Overall Study | NOT COMPLETED | T+P Concomitant Anthracycline-based Chemotherapy | 13 | |
| Overall Study | NOT COMPLETED | T+P Sequential Anthracycline-based Chemotherapy | 12 | |
| Overall Study | NOT COMPLETED | T+P Concomitant Non-Anthracycline Chemotherapy | 17 |
Source ClinicalTrials.gov
Adverse events435
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 | Diarrhoea | Gastrointestinal disorders | T+P Concomitant Anthracycline-based Chemotherapy | 46 | 72 | |
| other | Diarrhoea | Gastrointestinal disorders | T+P Sequential Anthracycline-based Chemotherapy | 44 | 75 | |
| other | Diarrhoea | Gastrointestinal disorders | T+P Concomitant Non-Anthracycline Chemotherapy | 55 | 76 | |
| other | Nausea | Gastrointestinal disorders | T+P Concomitant Anthracycline-based Chemotherapy | 38 | 72 | |
| other | Nausea | Gastrointestinal disorders | T+P Sequential Anthracycline-based Chemotherapy | 41 | 75 | |
| other | Nausea | Gastrointestinal disorders | T+P Concomitant Non-Anthracycline Chemotherapy | 34 | 76 | |
| other | Vomiting | Gastrointestinal disorders | T+P Concomitant Anthracycline-based Chemotherapy | 29 | 72 | |
| other | Vomiting | Gastrointestinal disorders | T+P Sequential Anthracycline-based Chemotherapy | 27 | 75 | |
| other | Vomiting | Gastrointestinal disorders | T+P Concomitant Non-Anthracycline Chemotherapy | 30 | 76 | |
| other | Dyspepsia | Gastrointestinal disorders | T+P Concomitant Anthracycline-based Chemotherapy | 19 | 72 |
1 to 10 of 435Source ClinicalTrials.gov
See all 435 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | T+P Concomitant Anthracycline-based Chemotherapy | ||
| Total, all-cause mortality | T+P Sequential Anthracycline-based Chemotherapy | ||
| Total, all-cause mortality | T+P Concomitant Non-Anthracycline Chemotherapy | ||
| Total, other adverse events | T+P Concomitant Anthracycline-based Chemotherapy | 72 | 72 |
| Total, other adverse events | T+P Sequential Anthracycline-based Chemotherapy | 73 | 75 |
| Total, other adverse events | T+P Concomitant Non-Anthracycline Chemotherapy | 76 | 76 |
| Total, serious adverse events | T+P Concomitant Anthracycline-based Chemotherapy | 23 | 72 |
| Total, serious adverse events | T+P Sequential Anthracycline-based Chemotherapy | 18 | 75 |
| Total, serious adverse events | T+P Concomitant Non-Anthracycline Chemotherapy | 31 | 76 |
Source ClinicalTrials.gov
Papers4
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 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.
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