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Cancer drug pertuzumab tested for Long-Term use in extension trial

NCT ID NCT02320435

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This study gives continued access to the cancer drug pertuzumab (Perjeta) for people with solid tumors who were already benefiting from it in a previous Roche trial. About 154 participants will receive the drug every 3 weeks, alone or with other treatments, until their disease worsens or side effects become too severe. Researchers will track how long patients live without their cancer growing, overall survival, and any side effects over time.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pertuzumab (Perjeta), sometimes with trastuzumab or other anti-cancer drugs
What this could lead to
If successful, this study could confirm that long-term pertuzumab treatment is safe and effective for controlling certain solid tumors.
What could go wrong
This is an extension study with no control group, so results are limited. Side effects like heart problems or liver injury are possible, and not all patients may benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

154 people

The number who actually took part.

Started

Feb 2015

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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% * 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

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Solid tumors

Contacts and locations

Locations

  • A.O. Universitaria Pisana

    Pisa, Tuscany, 56100, Italy

  • AUSL ? IRCCS Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42100, Italy

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asst Di Monza

    Monza, Lombardy, 20052, Italy

  • Az. Osp. S. Orsola Malpighi

    Bologna, Emilia-Romagna, 40138, Italy

  • Beijing Cancer Hospital

    Beijing, 100142, China

  • CENEIT Oncologicos

    Mexico City, 03100, Mexico

  • Cancerologia de Queretaro

    Querétaro City, Querétaro, 76090, Mexico

  • Centre Georges Francois Leclerc

    Dijon, 21079, France

  • Centre Henri Becquerel

    Rouen, 76038, France

  • Centre Rene Huguenin

    Saint-Cloud, 92210, France

  • Clinica Anglo Americana - Centro de Investigacion Oncologia CAA

    Lima, L27, Peru

  • Clinica Internacional, Sede San Borja

    Lima, Lima 41, Peru

  • Clinique Armoricaine Radiologie

    Saint-Brieuc, 22015, France

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032, China

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120, China

  • Gifu University Hospital

    Gifu, 501-1194, Japan

  • Harbin Medical University Cancer Hospital

    Harbin, 150081, China

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-080, Brazil

  • Hospital Metropolitano (Sede Lindora-Santa Ana)

    San José, 10903, Costa Rica

  • Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud

    Arequipa, 04001, Peru

  • Hospital Perola Byington

    São Paulo, São Paulo, 01317-000, Brazil

  • Hospital Sírio-Libanês

    São Paulo, São Paulo, 01308-050, Brazil

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, 38320, Spain

  • Hospital da Luz

    Lisbon, 1500-650, Portugal

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013, Spain

  • Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus

    Frankfurt am Main, 60389, Germany

  • ICO L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • IPO de Coimbra

    Coimbra, 3000-075, Portugal

  • IPO do Porto

    Porto, 4200-072, Portugal

  • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

    Meldola, Emilia-Romagna, 47014, Italy

  • Iem-Fucam

    D.F., Mexico CITY (federal District), 04980, Mexico

  • Instituto Nacional de Cancer - INCa

    Rio de Janeiro, 20560-120, Brazil

  • Instituto Nacional de Cancerologia

    Distrito Federal, 14080, Mexico

  • Instituto de Oncologia de Sorocaba - CEPOS

    Sorocaba, São Paulo, 18030-005, Brazil

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000, Brazil

  • Irccs Ist. Tumori Giovanni Paolo Ii

    Bari, Apulia, 70124, Italy

  • Irccs Istituto Europeo Di Oncologia (IEO)

    Milan, Lombardy, 20141, Italy

  • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

    Nanjing, 210029, China

  • Kursk Regional Clinical Oncology Dispensary

    Kursk, 305035, Russia

  • Liaoning cancer Hospital & Institute

    Shenyang, 110042, China

  • Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU

    Dnipropetrovsk, 49102, Ukraine

  • National Cancer Center Hospital East

    Chiba, 277-8577, Japan

  • Núcleo de Pesquisa São Camilo

    São Paulo, São Paulo, 04014-002, Brazil

  • Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda)

    Neumarkt, 92318, Germany

  • Praxis für Ambulante Onkologie im Krankenhaus Jerusalem

    Hamburg, 20357, Germany

  • Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

    Freiburg im Breisgau, 79110, Germany

  • SBI of Healthcare Samara Regional Clinical Oncology Dispensary

    Samara, 443031, Russia

  • Saitama Cancer Center

    Saitama, 362-0806, Japan

  • Samodzielny Publiczny Kliniczny Nr 1 W Lublinie

    Lublin, 20-081, Poland

  • Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722, South Korea

  • State Oncology Regional Treatment-Diagnostic Center

    Lviv, 79031, Ukraine

  • Studienzentrum UnterEms;Onkologische Schwerpunktpraxis Leer

    Leer, 26789, Germany

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • Vall d'Hebron Institute of Oncology (VHIO), Barcelona

    Barcelona, 08035, Spain

  • West China Hospital, Sichuan University

    Chengdu, 610041, China

  • Zhejiang Cancer Hospital

    Hangzhou, 310022, China

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