A Phase 2 interventional study of Pertuzumab and Trastuzumab in Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 55 sites in 20 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-06.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor receptor 2 (HER2)-positive breast cancer. Before surgery, participants will be randomized to receive either A) 6 cycles of pertuzumab plus trastuzumab (Herceptin), with 5-fluorouracil/epirubicin/cyclophosphamide (FEC) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus trastuzumab with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus trastuzumab with docetaxel and carboplatin. Pertuzumab will be administered at a loading dose of 840 mg intravenously (iv), then 420 mg iv 3-weekly, trastuzumab at a loading dose of 8 mg/kg iv, then 6 mg/kg iv 3-weekly, docetaxel at 75 mg/m\^2 iv, increased to 100 mg/m\^2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery participants will receive trastuzumab 6 mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 225 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.
Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab (T) and pertuzumab (P) every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Drug: Pertuzumab · Drug: Trastuzumab · Drug: FEC · Drug: Docetaxel
FEC every three weeks for three cycles, followed by docetaxel, trastuzumab (T) and pertuzumab (P) every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
Drug: Pertuzumab · Drug: Trastuzumab · Drug: FEC · Drug: Docetaxel
Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab (P) every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
Drug: Pertuzumab · Drug: TCH
840 mg loading dose intravenously (IV), then 420 mg IV 3-weekly.
Also known as: Perjeta
8 mg/kg loading dose IV, then 6 mg/kg every 3 weeks.
Also known as: Herceptin
5-fluorouracil 500 mg/m\^2, epirubicin 100 mg/m\^2 and cyclophosphamide 600 mg/m\^2.
75 mg/m\^2 for the first dose; 100 mg/m\^2 if no dose limiting toxicity occurs.
Trastuzumab followed by carboplatin at target area under the plasma concentration-time curve (AUC) 6 and docetaxel at a starting dose of 75 mg/m\^2. All treatments were given every three weeks by the IV route.
Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator
Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.
Time frame: From baseline up to approximately 3.5 years
Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period
Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of \<50% during the pre-operative (neoadjuvant) period.
Time frame: From baseline up to approximately 18 weeks
Efficacy: Percentage of Participants With Complete Pathological Response (pCR)
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.
Time frame: At surgery, after 18 weeks (6 cycles) of treatment
Efficacy: Clinical Response Rate
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.
Time frame: During each 3-week cycle of 6 total cycles: up to 18 weeks
Efficacy: Time to Clinical Response
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.
Time frame: Up to 18 weeks
Efficacy: Percentage of Participants Achieving Breast Conserving Surgery
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.
Time frame: At approximately 18 weeks
Efficacy: Percentage of Participants Without an Overall Survival (OS) Event
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.
Time frame: From baseline to end of study up to 5 years
Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event
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.
Time frame: From baseline to end of study up to 5 years
Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event
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.
Time frame: From baseline to end of study up to 5 years
Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD)
Percentage of participants with signs or symptoms of cardiac events.
Time frame: 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: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events
Percentage of participants with LVEF events without signs or symptoms of cardiac events.
Time frame: 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: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures
Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage.
Time frame: From baseline up to approximately 3.5 years
This study included 3 periods: Neoadjuvant (pre-operative) period and surgery, adjuvant (post-operative) period and post-treatment follow-up period.
| Milestone | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Started | 73 | 75 | 77 |
| Completed | 60 | 63 | 60 |
| Not completed | 13 | 12 | 17 |
| Withdrew: Violation of selection criteria at entry | 1 | 0 | 1 |
| Withdrew: Death | 5 | 7 | 10 |
| Withdrew: Refused treatment | 4 | 3 | 5 |
| Withdrew: Failure to return | 2 | 1 | 0 |
| Withdrew: Recurrence of disease | 0 | 1 | 0 |
| Withdrew: Other | 1 | 0 | 1 |
Left ventricular systolic dysfunction (LVSD) as assessed by the Investigator, including Grade 3, 4 or 5 symptomatic LVSD with symptomatic cardiac events.
| percentage of participants | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator | 0 | 2.7 | 1.3 |
Percentage of participants with LVEF measures decline of ≥ 10% from baseline and to a value of \<50% during the pre-operative (neoadjuvant) period.
| percentage of participants | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period | 5.6 | 5.3 | 3.9 |
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.
| percentage of participants | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Efficacy: Percentage of Participants With Complete Pathological Response (pCR) | 61.6 (49.5 to 72.8) | 57.3 (45.4 to 68.7) | 66.2 (54.6 to 76.6) |
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.
| percentage of participants | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Efficacy: Clinical Response Rate | 91.8 | 94.7 | 89.6 |
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.
| weeks | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Efficacy: Time to Clinical Response | 3.6 (3 to 6) | 6.3 (6 to 7) | 4.9 (4 to 6) |
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.
| percentage of participants | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Efficacy: Percentage of Participants Achieving Breast Conserving Surgery | 21.7 | 16.7 | 27.0 |
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.
| percentage of participants | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Efficacy: Percentage of Participants Without an Overall Survival (OS) Event | 93.2 | 90.7 | 87.0 |
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.
| percentage of participants | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event | 85.5 | 88.1 | 84.7 |
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.
| percentage of participants | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event | 86.3 | 85.3 | 81.8 |
Percentage of participants with signs or symptoms of cardiac events.
| percentage of participants | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Neoadjuvant Period (n=72, 75, 76) | 1.4 | 2.7 | 0 |
| Adjuvant Period (n= 68, 65, 67) | 0 | 0 | 1.5 |
| Follow-up Period (n=70, 75, 74) | 0 | 1.3 | 0 |
Percentage of participants with LVEF events without signs or symptoms of cardiac events.
| percentage of participants | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Neoadjuvant Period (n=72, 75, 76) | 5.6 | 4.0 | 2.6 |
| Adjuvant Period (n= 66, 64, 63) | 3.0 | 0 | 4.8 |
| Follow-up Period (n=21, 18, 23) | 0 | 11.1 | 4.3 |
Maximum decrease in LVEF measures is the change from baseline at worst treatment value. LVEF is measured as percentage.
| percentage (ejection fraction) | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures | -6.6 ± 5.15 | -8.4 ± 5.66 | -7.0 ± 6.48 |
Collected over Up to approximately 5 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| T+P Concomitant Anthracycline-based Chemotherapy | — | 23/72 (31.9%) | 72/72 (100%) |
| T+P Sequential Anthracycline-based Chemotherapy | — | 18/75 (24%) | 73/75 (97.3%) |
| T+P Concomitant Non-Anthracycline Chemotherapy | — | 31/76 (40.8%) | 76/76 (100%) |
| Event | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| Febrile NeutropeniaBlood and lymphatic system disorders | 10/72 | 4/75 | 11/76 |
| DiarrhoeaGastrointestinal disorders | 1/72 | 3/75 | 4/76 |
| NeutropeniaBlood and lymphatic system disorders | 2/72 | 3/75 | 1/76 |
| Left ventricular dysfunctionCardiac disorders | 1/72 | 3/75 | 1/76 |
| LeukopeniaBlood and lymphatic system disorders | 2/72 | 0/75 | 0/76 |
| PneumoniaInfections and infestations | 2/72 | 0/75 | 2/76 |
| Neutropenic infectionInfections and infestations | 0/72 | 2/75 | 1/76 |
| VomitingGastrointestinal disorders | 0/72 | 2/75 | 0/76 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/72 | 0/75 | 2/76 |
| Mucosal inflammationGeneral disorders | 0/72 | 0/75 | 2/76 |
| Event | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy |
|---|---|---|---|
| DiarrhoeaGastrointestinal disorders | 46/72 | 44/75 | 55/76 |
| AlopeciaSkin and subcutaneous tissue disorders | 35/72 | 39/75 | 42/76 |
| NauseaGastrointestinal disorders | 38/72 | 41/75 | 34/76 |
| NeutropeniaBlood and lymphatic system disorders | 36/72 | 33/75 | 37/76 |
| FatigueGeneral disorders | 30/72 | 28/75 | 33/76 |
| VomitingGastrointestinal disorders | 29/72 | 27/75 | 30/76 |
| AnaemiaBlood and lymphatic system disorders | 14/72 | 8/75 | 29/76 |
| ThrombocytopeniaBlood and lymphatic system disorders | 5/72 | 1/75 | 23/76 |
| HeadacheNervous system disorders | 20/72 | 15/75 | 16/76 |
| DyspepsiaGastrointestinal disorders | 19/72 | 9/75 | 17/76 |
Safety population included all participants who were randomized and received study drug.
| Age, Continuous(years) | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy | Total |
|---|---|---|---|---|
| Mean | 49.6 ± 11.41 | 50.5 ± 10.70 | 50.6 ± 10.58 | 50.6 ± 10.86 |
| Gender(Participants) | T+P Concomitant Anthracycline-based Chemotherapy | T+P Sequential Anthracycline-based Chemotherapy | T+P Concomitant Non-Anthracycline Chemotherapy | Total |
|---|---|---|---|---|
| Female | 73 | 75 | 77 | 225 |
| Male | 0 | 0 | 0 | 0 |
The record gives a start of Nov 2009, a primary completion of Jun 2011 and a completion of Jan 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jun 2016, 5 years after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pertuzumab