Solid TumorsPhase 3NCT02320435
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
A Phase 3 study testing Pertuzumab, Trastuzumab and Other Combination Anti-Cancer Therapies in people with Solid Tumors, run by Hoffmann-La Roche at 62 sites in 15 countries.
Trial summary
This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- Pertuzumab, Trastuzumab and Other Combination Anti-Cancer Therapies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 62 sitesin 15 countries
- Study dates
- 2 Feb 2015to 28 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure
- Investigator's opinion that the patient continues to benefit from treatment
Who cannot join
- Meets any of the exclusion criteria of the Parent protocol at the time the patient is considered for entry in the extension study
- Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study
- Permanent discontinuation of pertuzumab for any reason during the Parent study, or between the end of the Parent study and before enrollment into the extension study
- Any unresolved or irreversible toxicities during the Parent study that require permanent discontinuation of pertuzumab, according to Parent protocol or local label. Delay of treatment to wait for resolution of toxicities is allowed as long as it is within the guidelines of the respective Parent protocol and does not contradict exclusion criterion below.
- More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study
- Left ventricular ejection fraction </= 50%
Show all 12Show fewer
- Any serious uncontrolled concomitant disease that would contraindicate the use of pertuzumab or that would put the patient at high risk for treatment-related complications
- Treatment with any anti-cancer treatment (other than any treatment given as permitted in the Parent protocol) in the time period between last treatment in the Parent study and the first dose pertuzumab in the extension study (i.e. up to 9 weeks)
- Positive serum pregnancy test
- Women of child-bearing potential and men with partners of childbearing potential who do not agree to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner for the duration of study treatment and for at least 7 months after the last dose of study medication. Male patients who do not agree to refrain from donating sperm during this same period. Male patients whose partner is pregnant who do not agree to use condoms for the duration of the pregnancy.
- Concurrent participation in any therapeutic clinical trial (other than the Parent study)
- Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol
Trial locations and contacts
62 sites in 15 countries.
62 sites in 15 countries
China9 sites
Beijing Cancer Hospital
Beijing, 100142
The First Hospital of Jilin University
Changchun, 130021
West China Hospital, Sichuan University
Chengdu, 610041
Zhejiang Cancer Hospital
Hangzhou, 310022
Harbin Medical University Cancer Hospital
Harbin, 150081
Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
Nanjing, 210029
Fudan University Shanghai Cancer Center
Shanghai, 200032
Fudan University Shanghai Cancer Center
Shanghai, 200120
Liaoning cancer Hospital & Institute
Shenyang, 110042
Brazil8 sites
Hospital Amaral Carvalho
Jaú, São Paulo, 17210-080
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
Instituto Nacional de Cancer - INCa
Rio de Janeiro, 20560-120
Instituto do Cancer do Estado de Sao Paulo - ICESP
São Paulo, São Paulo, 01246-000
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050
Hospital Perola Byington
São Paulo, São Paulo, 01317-000
Núcleo de Pesquisa São Camilo
São Paulo, São Paulo, 04014-002
Instituto de Oncologia de Sorocaba - CEPOS
Sorocaba, São Paulo, 18030-005
Italy7 sites
Irccs Ist. Tumori Giovanni Paolo Ii
Bari, Apulia, 70124
Az. Osp. S. Orsola Malpighi
Bologna, Emilia-Romagna, 40138
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, 47014
Irccs Istituto Europeo Di Oncologia (IEO)
Milan, Lombardy, 20141
Asst Di Monza
Monza, Lombardy, 20052
A.O. Universitaria Pisana
Pisa, Tuscany, 56100
AUSL ? IRCCS Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42100
Spain6 sites
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
Hospital de Basurto
Bilbao, Vizcaya, 48013
ICO L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Germany5 sites
Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus
Frankfurt am Main, 60389
Praxis für Interdisziplinäre Onkologie und Hämatologie GbR
Freiburg im Breisgau, 79110
Praxis für Ambulante Onkologie im Krankenhaus Jerusalem
Hamburg, 20357
Studienzentrum UnterEms;Onkologische Schwerpunktpraxis Leer
Leer, 26789
Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)
Neumarkt, 92318
France4 sites
Centre Georges Francois Leclerc
Dijon, 21079
Centre Henri Becquerel
Rouen, 76038
Clinique Armoricaine Radiologie
Saint-Brieuc, 22015
Centre Rene Huguenin
Saint-Cloud, 92210
Mexico4 sites
Iem-Fucam
D.F., Mexico CITY (federal District), 04980
Instituto Nacional de Cancerologia
Distrito Federal, 14080
CENEIT Oncologicos
Mexico City, 03100
Cancerologia de Queretaro
Querétaro City, Querétaro, 76090
Portugal4 sites
IPO de Coimbra
Coimbra, 3000-075
Hospital da Luz
Lisbon, 1500-650
Hospital de Santa Maria
Lisbon, 1649-035
IPO do Porto
Porto, 4200-072
Japan3 sites
National Cancer Center Hospital East
Chiba, 277-8577
Gifu University Hospital
Gifu, 501-1194
Saitama Cancer Center
Saitama, 362-0806
Peru3 sites
Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud
Arequipa, 04001
Clinica Anglo Americana - Centro de Investigacion Oncologia CAA
Lima, L27
Clinica Internacional, Sede San Borja
Lima, Lima 41
South Korea3 sites
Seoul National University Hospital
Seoul, 03080
Severance Hospital, Yonsei University Health System
Seoul, 03722
Asan Medical Center
Seoul, 05505
Russia2 sites
Kursk Regional Clinical Oncology Dispensary
Kursk, 305035
SBI of Healthcare Samara Regional Clinical Oncology Dispensary
Samara, 443031
Ukraine2 sites
Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU
Dnipropetrovsk, 49102
State Oncology Regional Treatment-Diagnostic Center
Lviv, 79031
Costa Rica1 site
Hospital Metropolitano (Sede Lindora-Santa Ana)
San José, 10903
About this study
Official title: A Single-Arm Open-Label Multi-Centre Extension Study of Pertuzumab Administered As a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Study
This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.
- Conditions
- Solid Tumors
- Being tested
- Pertuzumab, Trastuzumab, Other Combination Anti-Cancer Therapies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PertuzumabDrug
Also called RO4368451, Perjeta
In general, patients will continue to receive 420 milligrams (mg) of pertuzumab administered as an intravenous infusion every 3 weeks following the guidance of the Parent protocol.
TrastuzumabDrug
If trastuzumab intravenous infusions were given in combination with pertuzumab as part of the Parent study, patients will continue to receive treatment at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure.
Other Combination Anti-Cancer TherapiesDrug
If other anti-cancer therapies were given in combination with pertuzumab as part of the Parent study, patients will receive all treatments at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure.
| Study group | Role | What they receive |
|---|---|---|
| Pertuzumab (Single-Agent or Combination Therapy) | Experimental | Pertuzumab will continue to be administered as a single agent or in combination with other anti-cancer therapies at the same dose, schedule, and guidelines that were in effect at the end of the Parent study. Receives: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Other Combination Anti-Cancer Therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-Free Survival
Measured: From date of first dose of pertuzumab in this study until the date of disease progression or death, whichever occurs first (up to approximately 10 years)
Overall Survival
Measured: From date of first dose of pertuzumab in this study until the date of death (up to approximately 10 years)
Number of Participants with Adverse Events by Severity, Classified According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Measured: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
Number of Participants with Adverse Events Leading to Pertuzumab Discontinuation or Dose Interruption
Measured: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
Number of Participants with Non-Serious Adverse Events of Special Interest (AESIs)
Non-serious AESIs for this study include the following: Cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's law; Suspected transmission of an infectious agent by the study drug; or, An asymptomatic decline in left ventricular ejection fraction (LVEF) requiring treatment or leading to discontinuation of human epidermal growth factor receptor 2 (HER2)-targeted therapies.
Measured: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
Left Ventricular Ejection Fraction (LVEF) Over Time
Measured: Baseline, every 3 treatment cycles (1 cycle is 21 days), and 28 days after last dose of pertuzumab (up to approximately 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study start2 Feb 2015
- Primary completion28 Mar 2027 (estimated)
- Study completion28 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 154 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
- NCT02320435
- Sponsor's protocol ID
- MO29406
- Other IDs
- 2014-002048-42, 2023-505102-42-00, 2023, 2014
- Status last verified
- Nov 2026
- First submitted
- 16 Dec 2014
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm Open-Label Multi-Centre Extension Study of Pertuzumab Administered As a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Study
- ClinicalTrials.gov ID
- NCT02320435
- Acronym / sponsor ID
- MO29406
- Conditions
- Solid Tumors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2015 (actual)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 28 Mar 2027 (estimated)
- First posted
- 19 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pertuzumab (Single-Agent or Combination Therapy) | Experimental | Drug: Pertuzumab, Drug: Trastuzumab, Drug: Other Combination Anti-Cancer TherapiesPertuzumab will continue to be administered as a single agent or in combination with other anti-cancer therapies at the same dose, schedule, and guidelines that were in effect at the end of the Parent study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Informed consent
- Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure
- Investigator's opinion that the patient continues to benefit from treatment
Key exclusion criteria (12 listed)
- Meets any of the exclusion criteria of the Parent protocol at the time the patient is considered for entry in the extension study
- Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study
- Permanent discontinuation of pertuzumab for any reason during the Parent study, or between the end of the Parent study and before enrollment into the extension study
- Any unresolved or irreversible toxicities during the Parent study that require permanent discontinuation of pertuzumab, according to Parent protocol or local label. Delay of treatment to wait for resolution of toxicities is allowed as long as it is within the guidelines of the respective Parent protocol and does not contradict exclusion criterion below.
- More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study
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: RO4368451, PerjetaIn general, patients will continue to receive 420 milligrams (mg) of pertuzumab administered as an intravenous infusion every 3 weeks following the guidance of the Parent protocol. | Drug | Pertuzumab (Single-Agent or Combination Therapy) |
| TrastuzumabIf trastuzumab intravenous infusions were given in combination with pertuzumab as part of the Parent study, patients will continue to receive treatment at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure. | Drug | Pertuzumab (Single-Agent or Combination Therapy) |
| Other Combination Anti-Cancer TherapiesIf other anti-cancer therapies were given in combination with pertuzumab as part of the Parent study, patients will receive all treatments at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure. | Drug | Pertuzumab (Single-Agent or Combination Therapy) |
Primary outcome
Progression-Free Survival
Time frame: From date of first dose of pertuzumab in this study until the date of disease progression or death, whichever occurs first (up to approximately 10 years)
Overall Survival
Time frame: From date of first dose of pertuzumab in this study until the date of death (up to approximately 10 years)
Number of Participants with Adverse Events by Severity, Classified According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03
Time frame: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
Number of Participants with Adverse Events Leading to Pertuzumab Discontinuation or Dose Interruption
Time frame: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
Number of Participants with Non-Serious Adverse Events of Special Interest (AESIs)
Time frame: From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years)
Non-serious AESIs for this study include the following: Cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's law; Suspected transmission of an infectious agent by the study drug; or, An asymptomatic decline in left ventricular ejection fraction (LVEF) requiring treatment or leading to discontinuation of human epidermal growth factor receptor 2 (HER2)-targeted therapies.
Left Ventricular Ejection Fraction (LVEF) Over Time
Time frame: Baseline, every 3 treatment cycles (1 cycle is 21 days), and 28 days after last dose of pertuzumab (up to approximately 10 years)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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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
62 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pertuzumab, Trastuzumab and Other Combination Anti-Cancer Therapies in people with Solid Tumors, run by Hoffmann-La Roche at 62 sites in 15 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 3 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in China, Brazil, Italy, Spain, Germany and 10 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Progression-Free Survival (time frame: From date of first dose of pertuzumab in this study until the date of disease progression or death, whichever occurs first (up to approximately 10 years)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2026.