Breast CancerPhase 2NCT00976989
A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
A Phase 2 study testing Pertuzumab, Trastuzumab and FEC in people with Breast Cancer, run by Hoffmann-La Roche at 55 sites in 20 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pertuzumab, Trastuzumab and FEC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 55 sitesin 20 countries
- Study dates
- Nov 2009to Jan 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female participants, age >/=18 years
- advanced, inflammatory or early stage unilateral invasive breast cancer
- HER2-positive breast cancer
- baseline left ventricular ejection fraction (LVEF) >/=55%
Who cannot join
- metastatic disease (Stage IV) or bilateral breast cancer
- previous anticancer therapy or radiotherapy for any malignancy
- other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma
- clinically relevant cardiovascular disease
- current chronic treatment with corticosteroids of >10mg methylprednisolone or equivalent
Trial locations and contacts
55 sites in 20 countries.
55 sites in 20 countries
United Kingdom7 sites
Study site
Bournemouth, BH7 7DW
Study site
Derby, DE1 2QY
Study site
Guildford, GU2 5XX
Study site
Newcastle upon Tyne, NE7 7DN
Study site
Southampton, SO16 6YD
Study site
Truro, TR1 3LJ
Study site
Westcliffe-on-sea, SS0 0RY
Germany6 sites
Study site
Heidelberg, 69120
Study site
Kiel, 24105
Study site
Regensburg, 93053
Study site
Trier, 54290
Study site
Troisdorf, 53840
Study site
Ulm, 89075
Spain4 sites
Study site
Barcelona, Barcelona, 08035
Study site
Córdoba, Cordoba, 14004
Study site
Donostia / San Sebastian, Guipuzcoa, 20014
Study site
Madrid, Madrid, 28222
Sweden4 sites
Study site
Eskilstuna, 63188
Study site
Stockholm, 17176
Study site
Sundsvall, 85186
Study site
Umeå, 90185
Canada3 sites
Study site
Montreal, Quebec, H3G 1A4
Study site
Ottawa, Ontario, K1H 8L6
Study site
Vancouver, British Columbia, V5Z 4E6
Italy3 sites
Study site
Monza, Lombardy, 20900
Study site
Rome, Lazio, 00168
Study site
S. Fermo Della Battaglia (CO), Lombardy, 22020
Romania3 sites
Study site
Bucharest, 050098
Study site
Cluj-Napoca, 400015
Study site
Iași, 700106
South Africa3 sites
Study site
Durban, 4058
Study site
Durban, 4091
Study site
Pretoria, 0002
Switzerland3 sites
Study site
Baden, 5405
Study site
Zurich, 8008
Study site
Zurich, 8091
Bosnia and Herzegovina2 sites
Study site
Banja Luka, 78000
Study site
Sarajevo, 71000
Brazil2 sites
Study site
Porto Alegre, Rio Grande do Sul, 90610-000
Study site
São Paulo, São Paulo, 01317-000
The Bahamas1 site
Study site
Nassau, N9311
About this study
Official title: A Randomised, Multicentre, Multinational Phase II Study to Evaluate Pertuzumab in Combination With Trastuzumab, Given Either Concomitantly or Sequentially With Standard Anthracycline-based Chemotherapy or Concomitantly With a Non-anthracycline-based Chemotherapy Regimen, as Neoadjuvant Therapy for Patients With Locally Advanced, Inflammatory or Early Stage HER2-positive Breast Cancer
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.
- Conditions
- Breast Cancer
- Being tested
- Pertuzumab, Trastuzumab, FEC, Docetaxel, TCH
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PertuzumabDrug
Also called Perjeta
840 mg loading dose intravenously (IV), then 420 mg IV 3-weekly.
TrastuzumabDrug
Also called Herceptin
8 mg/kg loading dose IV, then 6 mg/kg every 3 weeks.
FECDrug
5-fluorouracil 500 mg/m^2, epirubicin 100 mg/m^2 and cyclophosphamide 600 mg/m^2.
DocetaxelDrug
75 mg/m^2 for the first dose; 100 mg/m^2 if no dose limiting toxicity occurs.
TCHDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| T+P Concomitant Anthracycline-based chemotherapy | Experimental | 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. Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: FEC; Drug: Docetaxel |
| T+P Sequential Anthracycline-based chemotherapy | Experimental | 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. Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: FEC; Drug: Docetaxel |
| T+P Concomitant Non-Anthracycline chemotherapy | Experimental | 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. Receives: Drug: Pertuzumab; Drug: TCH |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline up to approximately 18 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline up to approximately 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startNov 2009
- Primary completionJun 2011
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00976989
- Sponsor's protocol ID
- BO22280
- Other IDs
- 2009-012019-17, 2009
- Status last verified
- May 2016
- First submitted
- 14 Sep 2009
- Last updated
- 6 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Waldron-Lynch M, Eng-Wong J, Kirk S, Cortes J. Long-term efficacy analysis of the randomised, phase II TRYPHAENA cardiac safety study: Evaluating pertuzumab and trastuzumab plus standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer. Eur J Cancer. 2018 Jan;89:27-35. doi: 10.1016/j.ejca.2017.10.021. Epub 2017 Dec 8.
PubMed 29223479Swain SM, Schneeweiss A, Gianni L, Gao JJ, Stein A, Waldron-Lynch M, Heeson S, Beattie MS, Yoo B, Cortes J, Baselga J. Incidence and management of diarrhea in patients with HER2-positive breast cancer treated with pertuzumab. Ann Oncol. 2017 Apr 1;28(4):761-768. doi: 10.1093/annonc/mdw695.
PubMed 28057664Schneeweiss A, Chia S, Hegg R, Tausch C, Deb R, Ratnayake J, McNally V, Ross G, Kiermaier A, Cortes J. Evaluating the predictive value of biomarkers for efficacy outcomes in response to pertuzumab- and trastuzumab-based therapy: an exploratory analysis of the TRYPHAENA study. Breast Cancer Res. 2014 Jul 8;16(4):R73. doi: 10.1186/bcr3690.
PubMed 25005255Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, McNally V, Ross G, Cortes J. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013 Sep;24(9):2278-84. doi: 10.1093/annonc/mdt182. Epub 2013 May 22.
PubMed 23704196
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Multicentre, Multinational Phase II Study to Evaluate Pertuzumab in Combination With Trastuzumab, Given Either Concomitantly or Sequentially With Standard Anthracycline-based Chemotherapy or Concomitantly With a Non-anthracycline-based Chemotherapy Regimen, as Neoadjuvant Therapy for Patients With Locally Advanced, Inflammatory or Early Stage HER2-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT00976989
- Acronym / sponsor ID
- BO22280
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 15 Sep 2009 (estimated)
- Results
- Posted 20 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| T+P Concomitant Anthracycline-based chemotherapy | Experimental | Drug: Pertuzumab, Drug: Trastuzumab, Drug: FEC, Drug: Docetaxel5-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. |
| T+P Sequential Anthracycline-based chemotherapy | Experimental | Drug: Pertuzumab, Drug: Trastuzumab, Drug: FEC, Drug: DocetaxelFEC 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. |
| T+P Concomitant Non-Anthracycline chemotherapy | Experimental | Drug: Pertuzumab, Drug: TCHTrastuzumab, 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- female participants, age >/=18 years
- advanced, inflammatory or early stage unilateral invasive breast cancer
- HER2-positive breast cancer
- baseline left ventricular ejection fraction (LVEF) >/=55%
Key exclusion criteria (5 listed)
- metastatic disease (Stage IV) or bilateral breast cancer
- previous anticancer therapy or radiotherapy for any malignancy
- other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma
- clinically relevant cardiovascular disease
- current chronic treatment with corticosteroids of >10mg methylprednisolone or equivalent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PertuzumabAlso: Perjeta840 mg loading dose intravenously (IV), then 420 mg IV 3-weekly. | Drug | T+P Concomitant Anthracycline-based chemotherapy, T+P Concomitant Non-Anthracycline chemotherapy, T+P Sequential Anthracycline-based chemotherapy |
| TrastuzumabAlso: Herceptin8 mg/kg loading dose IV, then 6 mg/kg every 3 weeks. | Drug | T+P Concomitant Anthracycline-based chemotherapy, T+P Sequential Anthracycline-based chemotherapy |
| FEC5-fluorouracil 500 mg/m^2, epirubicin 100 mg/m^2 and cyclophosphamide 600 mg/m^2. | Drug | T+P Concomitant Anthracycline-based chemotherapy, T+P Sequential Anthracycline-based chemotherapy |
| Docetaxel75 mg/m^2 for the first dose; 100 mg/m^2 if no dose limiting toxicity occurs. | Drug | T+P Concomitant Anthracycline-based chemotherapy, T+P Sequential Anthracycline-based chemotherapy |
| TCHTrastuzumab 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. | Drug | T+P Concomitant Non-Anthracycline chemotherapy |
Primary outcome
Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator
Time frame: 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.
Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period
Time frame: 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.
10 secondary outcomes
Efficacy: Percentage of Participants With Complete Pathological Response (pCR)
Time frame: At surgery, after 18 weeks (6 cycles) of treatment
Efficacy: Clinical Response Rate
Time frame: During each 3-week cycle of 6 total cycles: up to 18 weeks
Efficacy: Time to Clinical Response
Time frame: Up to 18 weeks
Efficacy: Percentage of Participants Achieving Breast Conserving Surgery
Time frame: At approximately 18 weeks
Efficacy: Percentage of Participants Without an Overall Survival (OS) Event
Time frame: From baseline to end of study up to 5 years
Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event
Time frame: From baseline to end of study up to 5 years
Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event
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)
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
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
Time frame: From baseline up to approximately 3.5 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29223479Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Waldron-Lynch M, Eng-Wong J, Kirk S, Cortes J. Long-term efficacy analysis of the randomised, phase II TRYPHAENA cardiac safety study: Evaluating pertuzumab and trastuzumab plus standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer. Eur J Cancer. 2018 Jan;89:27-35. doi: 10.1016/j.ejca.2017.10.021. Epub 2017 Dec 8.
- Derived from this study: PubMed 28057664Swain SM, Schneeweiss A, Gianni L, Gao JJ, Stein A, Waldron-Lynch M, Heeson S, Beattie MS, Yoo B, Cortes J, Baselga J. Incidence and management of diarrhea in patients with HER2-positive breast cancer treated with pertuzumab. Ann Oncol. 2017 Apr 1;28(4):761-768. doi: 10.1093/annonc/mdw695.
- Derived from this study: PubMed 25005255Schneeweiss A, Chia S, Hegg R, Tausch C, Deb R, Ratnayake J, McNally V, Ross G, Kiermaier A, Cortes J. Evaluating the predictive value of biomarkers for efficacy outcomes in response to pertuzumab- and trastuzumab-based therapy: an exploratory analysis of the TRYPHAENA study. Breast Cancer Res. 2014 Jul 8;16(4):R73. doi: 10.1186/bcr3690.
- Derived from this study: PubMed 23704196Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, McNally V, Ross G, Cortes J. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013 Sep;24(9):2278-84. doi: 10.1093/annonc/mdt182. Epub 2013 May 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
55 sites in 20 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pertuzumab, Trastuzumab and FEC in people with Breast Cancer, run by Hoffmann-La Roche at 55 sites in 20 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in United Kingdom, Germany, Spain, Sweden, Canada and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator (time frame: From baseline up to approximately 3.5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00976989, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017; AzTrials last refreshed its copy on 26 Oct 2026.