AzTrials
AzTrials

Breast CancerPhase 3NCT01810393

A Study to Assess Preference for Subcutaneous Trastuzumab Treatment in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Metastatic Breast Cancer Responding to First-Line Intravenous Trastuzumab for at Least 3 Years

A Phase 3 study testing Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 61 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
114 participants
Where
61 sitesFrance
Study dates
11 Jun 2013to 17 Jul 2019
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Histologically or cytologically confirmed HER2-positive metastatic breast cancer
  • On treatment with first-line trastuzumab IV and free of disease progression for at least 3 years
  • Left ventricular ejection fraction (LVEF) of greater than or equal to (>/=) 50 percent (%)
  • Hormonal therapy will be allowed
  • Prior use of anti-HER2 therapy will be allowed

Who cannot join

  • History of other malignancy, except for curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies who have been disease-free for at least 5 years; participants with previous ductal carcinoma in situ of the breast are also eligible
  • Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
  • Serious cardiac illness or medical conditions that would preclude the use of trastuzumab
  • Hepatitis B, hepatitis C or human immunodeficiency virus infection
  • Pregnant or lactating women
  • Concurrent enrollment in an other clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Show all 9Show fewer
  • Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase or the adhesive of the subcutaneous device, or a history of severe allergic or immunological reactions, for example, difficult to control asthma
  • Central nervous system metastases, unless they have been treated and have been stable for at least 3 years
  • Inadequate organ function

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

France61 sites

  • Clinique Du Docteur Calabet; Cromg

    Agen, 47000

  • Clinique De L Europe; Radiotherapie Chimiotherapie

    Amiens, 80090

  • ICO Paul Papin; Oncologie Medicale.

    Angers, 49055

  • HOP Prive Arras Les Bonnettes; Chimiotherapie

    Arras, 62012

  • Institut Sainte-Catherine; Oncologie

    Avignon, 84082

  • Centre Hospitalier de La Cote Basque; Oncologie

    Bayonne, 64109

  • HOPITAL JEAN MINJOZ; Oncologie

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Hospitalier Fleyriat; Oncologie/Hematologie

    Bourg-en-Bresse, 01012

  • Hopital Morvan

    Brest, 29200

  • Clinique Pasteur Lanroze; Chimiotherapie Radiotherapie

    Brest, 29220

  • Centre Francois Baclesse; Oncologie

    Caen, 14076

  • Centre Jean Perrin; Oncologie

    Clermont-Ferrand, 63011

  • Pole Sante Republique;Oncologie Hematologie

    Clermont-Ferrand, 63050

  • Chi De Creteil; Radiotherapie Oncologie

    Créteil, 94010

  • Centre Leonard De Vinci;Chimiotherapie

    Dechy, 59187

  • Centre Georges Francois Leclerc; Oncologie 3

    Dijon, 21079

  • CHD Les Oudairies

    La Roche-sur-Yon, 85925

  • Ch Louis Pasteur; Oncologie

    Le Coudray, 28630

  • Clinique Victor Hugo; Radiotherapie

    Le Mans, 72015

  • Polyclinique Du Bois; Oncologie

    Lille, 59003

  • Centre Oscar Lambret; Unite de Recherche Clinique

    Lille, 59020

  • Ch Bretagne Sud Site Scorff; Oncologie Medicale

    Lorient, 56100

  • Centre Leon Berard

    Lyon, 69008

  • Clinique De La Sauvegarde; Chimiotherapie

    Lyon, 69337

  • Hopital Prive Jean Mermoz

    Lyon, 69373

  • Institut Paoli Calmettes; Oncologie Medicale

    Marseille, 13273

  • Hopital de Mercy ;ONCOLOGIE MEDICALE

    Melz-sur-Seine, 57085

  • Hopital Belle Isle; Oncologie Hematologie

    Metz, 57045

  • Clinique Clementville; Hopital De Jour

    Montpellier, 34070

  • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE

    Nancy, 54100

  • Centre Catherine de Sienne; Chimiotherapie

    Nantes, 44202

  • Centre Antoine Lacassagne

    Nice, 06189

  • Institut de cancerologie du Gard

    Nîmes, 30029

  • HOPITAL DE LA SOURCE; Service de Cardiologie, Point Jaune

    Orléans, 45100

  • APHP - Hopital de la Pitie Salpetriere

    Paris, 75013

  • Groupe Hospitalier Diaconesses

    Paris, 75020

  • Institut Curie; Oncologie Medicale

    Paris, 75231

  • Hopital Saint Louis; Oncologie Medicale

    Paris, 75475

  • HOPITAL TENON; Cancerologie Medicale

    Paris, 75970

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, 86021

  • CH d'Annecy

    Pringy, 74370

  • Chi De Cornouaille; Oncologie Hospitalisation

    Quimper, 29107

  • Institut Jean Godinot; Oncologie Medicale

    Reims, 51056

  • Institut du Cancer Coulancy Reims

    Reims, 51100

  • Centre Eugene Marquis; Bureau D Etudes Cliniques

    Rennes, 35042

  • Centre Henri Becquerel; Oncologie Medicale

    Rouen, 76038

  • Chp Saint Gregoire; Cancerologie Radiotherapie

    Saint-Grégoire, 35768

  • Centre Rene Gauducheau

    Saint-Herblain, 44805

  • Polyclinique de la Cote Basque Sud; Oncologie

    Saint-Jean-de-Luz, 64501

  • CMCO De La Cote D Opale; Auberge De Jour

    Saint-Martin-Boulogne, 62280

  • Clinique Mutualiste L Estuaire

    Saint-Nazaire, 44606

  • Institut de Cancérologie de Loire

    Saint-Priest-en-Jarez, 42271

  • CH de Saint Quentin

    Saint-Quentin, 2100

  • Hopital Prive Nord Parisien; Soins De Suite - Oncologie

    Sarcelles, 95200

  • Clinique Ste Anne

    Strasbourg, 67000

  • Centre Paul Strauss; Oncologie Medicale

    Strasbourg, 67065

  • Hopital de Hautepierre

    Strasbourg, 67091

  • Hôpital Rangueil - CHU de Toulouse

    Toulouse, 31059

  • Clinique Pasteur; Oncologie Medicale

    Toulouse, 31076

Other trials in France

About this study

Official title: An Open-Label, Randomized, Multicenter Phase III Study in Patients With HER2-Positive Metastatic Breast Cancer Responding to First Line Treatment With Intravenous Trastuzumab for at Least 3 Years and Investigating Patient Preference for Subcutaneous Trastuzumab

This open-label, randomized, multicenter study will evaluate participant preference for subcutaneous (SC) versus intravenous (IV) trastuzumab (Herceptin) in participants with HER2-positive metastatic breast cancer responding to first-line treatment with IV trastuzumab for at least 3 years. Participants will be randomized to receive either 3 cycles (cycle length = 21 days) of trastuzumab SC followed by 3 cycles of trastuzumab IV or 3 cycles of trastuzumab IV followed by 3 cycles of trastuzumab SC. All participants will receive trastuzumab SC for Cycles 7 to 18. Anticipated time on study treatment is 1 year or until disease progression or inacceptable toxicity occurs, whichever comes first.

Conditions
Breast Cancer
Being tested
Trastuzumab
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TrastuzumabDrug

    Also called Herceptin

    Trastuzumab will be administered at a dose of 6 milligrams per kilogram (mg/kg) IV or 600 milligrams per 5 milliliter (mg/5mL) SC in 21-day cycles as per schedule described in respective arm.

Study groups in NCT01810393
Study groupRoleWhat they receive
Trastuzumab IV Then Trastuzumab SCExperimentalParticipants will receive treatment with Trastuzumab IV for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab SC for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.
Receives: Drug: Trastuzumab
Trastuzumab SC Then Trastuzumab IVExperimentalParticipants will receive treatment with Trastuzumab SC for the first 3 cycles (cycle length = 21 days) followed by Trastuzumab IV for the next 3 cycles. Participants will continue receiving treatment with trastuzumab SC for another 12 cycles (if SC treatment is well tolerated, otherwise participants will continue IV treatment) for a total of 18 cycles of treatment during the study.
Receives: Drug: Trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score

    Measured: Baseline up to 6 cycles (cycle length = 21 days)

Secondary outcomes (2)

  1. Percentage of Participants With Adverse Events

    Measured: approximately 4 years

  2. Percentage of Health Care Professionals With Preference for Either SC or IV Administration According to Health Care Professional Questionnaire (HCPQ) Score

    Measured: Baseline up to 6 cycles (cycle length = 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2013 (estimated)
  2. Study start11 Jun 2013
  3. Primary completion17 Jul 2019
  4. Study completion17 Jul 2019

Resources

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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
114 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01810393
Sponsor's protocol ID
ML28589
Other IDs
2012-003442-32
Status last verified
Sep 2020
First submitted
11 Mar 2013
Last updated
4 Sep 2020
Results posted
No

Publications

  • Pivot X, Spano JP, Espie M, Cottu P, Jouannaud C, Pottier V, Moreau L, Extra JM, Lortholary A, Rivera P, Spaeth D, Attar-Rabia H, Benkanoun C, Dima-Martinez L, Esposito N, Gligorov J. Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study. Eur J Cancer. 2017 Sep;82:230-236. doi: 10.1016/j.ejca.2017.05.009. Epub 2017 Jun 23.

    PubMed 28648618

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab in people with Breast Cancer, run by Hoffmann-La Roche at 61 sites in France.

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 5 inclusion and 9 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 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Percentage of Participants With Preference for Either SC or IV Route of Administration According to Participant Preference Questionnaire (PPQ) Score (time frame: Baseline up to 6 cycles (cycle length = 21 days)). 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 NCT01810393, which also lists 1 linked publication.

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 4 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in