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Breast CancerPhase 3NCT00381901

Trastuzumab for 6 Months or 1 Year in Treating Women With Nonmetastatic Breast Cancer That Can Be Removed By Surgery

A Phase 3 study testing trastuzumab, polymorphism analysis and adjuvant therapy in people with Breast Cancer, run by National Cancer Institute, France at 82 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

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. 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?
trastuzumab, polymorphism analysis and adjuvant therapy
Type of treatment
Surgery or procedure
How many people
3,400 participants
Where
82 sitesFrance
Study dates
May 2006to May 2011
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the breast
  • Nonmetastatic disease
  • Positive or negative axillary nodes
  • Tumor size ≥ 10 mm
  • Resectable disease
  • Must have received ≥ 4 courses of chemotherapy for this disease
  • A 12-month adjuvant treatment with trastuzumab (Herceptin®) has been initiated
  • Informed consent form must be signed between the third and sixth months of trastuzumab therapy
  • Overexpression of HER-2 in the invasive component of the primary tumor as indicated by 1 of the following:
  • 3+ by immunohistochemistry (IHC)
  • 2+ by IHC and confirmation by fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH)
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • LVEF considered favorable for continuing trastuzumab treatment as measured by echocardiography or MUGA at 2-4 months after beginning adjuvant trastuzumab
  • No serious cardiac illness or medical condition precluding trastuzumab treatment, including any of the following:
  • History of documented congestive heart failure
  • High-risk uncontrolled arrhythmias
  • Angina pectoris requiring antianginal medication
  • Severe dyspnea at rest or oxygen-dependent
  • No known hypersensitivity to trastuzumab, murine proteins, or any of the excipients
  • Not pregnant or nursing
  • No social, geographical, or psychological condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Other prior anti-HER-2 therapy allowed
  • No prior trastuzumab other than initiation of trastuzumab adjuvant therapy

Trial locations and contacts

82 sites in 1 country.

82 sites in 1 country

France82 sites

  • Centre Paul Papin

    Angers, 49036

  • Centre Hospitalier d'Annecy

    Annecy, 74011 Cedex

  • Centre Hospitalier La Fontonne

    Antibes, 06600

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

  • Centre Hospital General Robert Ballanger

    Aulnay-sous-Bois, 93602

  • Institut Sainte Catherine

    Avignon, 84082

  • C.H.G. Beauvais

    Beauvais, 60021

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Hopital Avicenne

    Bobigny, 93009

  • Institut Bergonie

    Bordeaux, 33076

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33300

  • Clinique Tivoli

    Bordeaux, F-33000

  • Centre Hospitalier Docteur Duchenne

    Boulogne-sur-Mer, 62200

  • C.H.U. de Brest

    Brest, 29200

  • Centre Hospitalier General

    Brivé, 19101

  • Centre Hospitalier William Morey

    Chalon-sur-Saône, 71100

  • Clinique Notre Dame du Bon Secours

    Chartres, 28000

  • Hopital Louis Pasteur

    Chartres, 28018

  • Hopital Antoine Beclere

    Clamart, 92141

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Hopital Louis Pasteur

    Colmar, 68024

  • Centre Hospitalier de Dax

    Dax, 40100

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • Hopital Jean Monnet

    Épinal, 88021

  • Hopital Clarac

    Fort de France Cedex, 97261

  • Institut Prive de Cancerologie

    Grenoble, 38100

  • Clinique Sainte-Marguerite

    Hyères, 83400

  • Centre De Radiotherapie Charlebourg

    La Garenne-Colombes, 92250

  • Centre Hospitalier Departemental

    La Roche-sur-Yon, 85025

  • Centre Hospitalier de Lagny

    Lagny-sur-Marne, 77405

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Clinique Victor Hugo

    Le Mans, F-72000

  • Institut d'Oncologie Hartmann

    Levallois-Perret, 92300

  • Hopital Robert Boulin

    Libourne, 33500

  • Clinique Chenieux

    Limoges, 87000

  • Centre Hospital Regional Universitaire de Limoges

    Limoges, 87042

  • Centre Medical Parot

    Lyon, 69006

  • Centre Leon Berard

    Lyon, 69373

  • Hopital Edouard Herriot - Lyon

    Lyon, 69437

  • Centre de Radiotherapie et Oncologie Saint-Faron

    Mareuil-lès-Meaux, 77100

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • Hopital Clinique Claude Bernard

    Metz, 57072

  • Centre de Radiologie et de Traitement des Tumeurs

    Meudon-la-Forêt, 92360

  • CH Meulan

    Meulan-en-Yvelines, 78250

  • Centre Hospitalier General de Mont de Marsan

    Mont-de-Marsan, 40000

  • Centre Hospitalier de Montelimar

    Montélimar, 26200

  • Centre Hospitalier de Montlucon

    Montluçon, 03109

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298

  • Clinique Clementville

    Montpellier

  • Centre Azureen de Cancerologie

    Mougins, 06250

  • Centre Catherine de Sienne

    Nantes, 02

  • Centre Regional Rene Gauducheau

    Nantes-Saint-Herblain, 44805

  • Clinique Les Genets

    Narbonne, 11100

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • Clinique Belvedere

    Nice, 06000

  • Clinique Saint George

    Nice, 06100

  • Centre Antoine Lacassagne

    Nice, 06189

  • C.H.U. de Nimes - Groupe Hospitals-Universitaire Caremeau

    Nîmes, 30029

  • Clinique De Valdegour

    Nîmes, 30900

  • Hopital Europeen Georges Pompidou

    Paris, 75015

  • Institut Curie Hopital

    Paris, 75248

  • Hopital Saint-Louis

    Paris, 75475

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Centre Hospitalier - Pau

    Pau, 64046

  • Polyclinique Francheville

    Périgueux, 24004

  • Clinique Saint - Pierre

    Perpignan

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Intercommunal de Poissy

    Poissy, 78300

  • Hopital Jean Bernard

    Poitiers, 86021

  • Institut Jean Godinot

    Reims, 51056

  • Centre Eugene Marquis

    Rennes, 35042

  • CHG Roanne

    Roanne, F-42300

  • Centre Henri Becquerel

    Rouen, 76038

  • Clinique Armoricaine De Radiologie

    Saint-Brieuc, F-22015

  • Centre Etienne Dolet

    Saint-Nazaire, 44600

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42270

  • Clinique Sainte Clotilde

    Sainte Clotilde, 97192

  • Clinique de l'Orangerie

    Strasbourg, 67010

  • Centre Paul Strauss

    Strasbourg, 67065

  • Centre Hospitalier Intercommunal Toulon - La Seyne Sur Mer

    Toulon, 83056

  • Institut Claudius Regaud

    Toulouse, 31052

  • Centre Hospitalier Universitaire Bretonneau de Tours

    Tours, 37044

Other trials in France

About this study

Official title: Protocol of Herceptin Adjuvant With Reduced Exposure, a Randomised Comparison of 6 Months vs 12 Months in All Women Receiving Adjuvant Herceptin [PHARE]

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving trastuzumab for 6 months is as effective as giving trastuzumab for 1 year in treating patients with breast cancer.

PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works when given for 6 months compared to 12 months in treating women with nonmetastatic breast cancer that can be removed by surgery.

Read the detailed description

OBJECTIVES:

Primary

  • Compare the disease-free survival of women with nonmetastatic, resectable breast cancer treated with adjuvant trastuzumab (Herceptin®) for 6 months vs 12 months.

Secondary

  • Compare cardiotoxicity in patients receiving these regimens.
  • Compare the cardiotoxicity and disease-free survival of patients receiving concurrent trastuzumab and chemotherapy vs sequential administration.
  • Correlate HER-2 polymorphism with disease-free survival/cardiotoxicity in these patients.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, modality of adjuvant chemotherapy (concurrent vs sequential), and adjuvant hormonal therapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (control arm, 12-month therapy): Patients continue to receive trastuzumab (Herceptin®) IV until a total of 12 months of therapy is completed in the absence of disease progression or unacceptable toxicity.
  • Arm II (experimental arm, 6-month therapy): Patients continue to receive trastuzumab* IV until a total of 6 months of therapy is completed in the absence of disease progression or unacceptable toxicity.

NOTE: *Patients who have already finished 6 months of trastuzumab at randomization do not receive further trastuzumab.

Some patients undergo blood collection for HER-2 polymorphism analysis.

After completion of study therapy, patients are followed periodically for approximately 5 years.

PROJECTED ACCRUAL: A total of 7,000 patients will be accrued for this study.

Conditions
Breast Cancer
Being tested
trastuzumab, polymorphism analysis, adjuvant therapy
Keywords
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IA breast cancer, stage IB breast cancer, recurrent breast cancer, stage IIIC breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

What is being measured

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

  1. Time to recurrence

Secondary outcomes (3)

  1. Cardiotoxicity as measured by LVEF

  2. Distant metastasis-free survival

  3. Overall survival

Timeline

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

  1. First posted28 Sep 2006 (estimated)
  2. Study startMay 2006
  3. Primary completionMay 2011

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
Enrolment
3,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00381901
Sponsor's protocol ID
CDR0000509793
Other IDs
INCA-PHARE, INCA-RECF0146, EUDRACT-2006-000070-67
Status last verified
Jul 2009
First submitted
26 Sep 2006
Last updated
13 May 2011
Results posted
No

Publications

  • Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espie M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Venat-Bouvet L, Cany L, Catala S, Khayat D, Gambotti L, Pauporte I, Faure-Mercier C, Paget-Bailly S, Henriques J, Grouin JM; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab in early breast cancer (PHARE): final analysis of a multicentre, open-label, phase 3 randomised trial. Lancet. 2019 Jun 29;393(10191):2591-2598. doi: 10.1016/S0140-6736(19)30653-1. Epub 2019 Jun 6.

    PubMed 31178155

  • Jacquinot Q, Paget-Bailly S, Fumoleau P, Romieu G, Pierga JY, Espie M, Lortholary A, Nabholtz JM, Mercier CF, Pauporte I, Henriques J, Pivot X. Fluctuation of the left ventricular ejection fraction in patients with HER2-positive early breast cancer treated by 12 months of adjuvant trastuzumab. Breast. 2018 Oct;41:1-7. doi: 10.1016/j.breast.2018.06.001. Epub 2018 Jun 15.

    PubMed 29913374

  • Curtit E, Pivot X, Henriques J, Paget-Bailly S, Fumoleau P, Rios M, Bonnefoi H, Bachelot T, Soulie P, Jouannaud C, Bourgeois H, Petit T, Tennevet I, Assouline D, Mathieu MC, Jacquin JP, Lavau-Denes S, Darut-Jouve A, Ferrero JM, Tarpin C, Levy C, Delecroix V, Trillet-Lenoir V, Cojocarasu O, Meunier J, Pierga JY, Kerbrat P, Faure-Mercier C, Blanche H, Sahbatou M, Boland A, Bacq D, Besse C, Thomas G, Deleuze JF, Pauporte I, Romieu G, Cox DG. Assessment of the prognostic role of a 94-single nucleotide polymorphisms risk score in early breast cancer in the SIGNAL/PHARE prospective cohort: no correlation with clinico-pathological characteristics and outcomes. Breast Cancer Res. 2017 Aug 22;19(1):98. doi: 10.1186/s13058-017-0888-4.

    PubMed 28830573

  • Pivot X, Fumoleau P, Pierga JY, Delaloge S, Bonnefoi H, Bachelot T, Jouannaud C, Bourgeois H, Rios M, Soulie P, Jacquin JP, Lavau-Denes S, Kerbrat P, Cox D, Faure-Mercier C, Pauporte I, Gligorov J, Curtit E, Henriques J, Paget-Bailly S, Romieu G. Superimposable outcomes for sequential and concomitant administration of adjuvant trastuzumab in HER2-positive breast cancer: Results from the SIGNAL/PHARE prospective cohort. Eur J Cancer. 2017 Aug;81:151-160. doi: 10.1016/j.ejca.2017.05.020. Epub 2017 Jun 16.

    PubMed 28624696

  • Pivot X, Suter T, Nabholtz JM, Pierga JY, Espie M, Lortholary A, Khayat D, Pauporte I, Romieu G, Kramar A, Fumoleau P. Cardiac toxicity events in the PHARE trial, an adjuvant trastuzumab randomised phase III study. Eur J Cancer. 2015 Sep;51(13):1660-6. doi: 10.1016/j.ejca.2015.05.028. Epub 2015 Jul 7.

    PubMed 26163096

  • Kramar A, Bachelot T, Madrange N, Pierga JY, Kerbrat P, Espie M, Fumoleau P, Pauporte I, Khayat D, Romieu G, Pivot X. Trastuzumab duration effects within patient prognostic subgroups in the PHARE trial. Ann Oncol. 2014 Aug;25(8):1563-70. doi: 10.1093/annonc/mdu177. Epub 2014 May 14.

    PubMed 24827132

  • Pivot X, Romieu G, Debled M, Pierga JY, Kerbrat P, Bachelot T, Lortholary A, Espie M, Fumoleau P, Serin D, Jacquin JP, Jouannaud C, Rios M, Abadie-Lacourtoisie S, Tubiana-Mathieu N, Cany L, Catala S, Khayat D, Pauporte I, Kramar A; PHARE trial investigators. 6 months versus 12 months of adjuvant trastuzumab for patients with HER2-positive early breast cancer (PHARE): a randomised phase 3 trial. Lancet Oncol. 2013 Jul;14(8):741-8. doi: 10.1016/S1470-2045(13)70225-0. Epub 2013 Jun 11.

    PubMed 23764181

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing trastuzumab, polymorphism analysis and adjuvant therapy in people with Breast Cancer, run by National Cancer Institute, France at 82 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?

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 13 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 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?

Time to recurrence. 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 NCT00381901, which also lists 7 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 13 May 2011.

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