NCT00637325

Brief Summary

This is an open-label, randomised phase III, multicentre, Italian study designed to investigate the role of trastuzumab in patients with locally advanced and/or metastatic breast cancer over expressing HER2 who received a first line chemotherapy containing trastuzumab. The trial in divided in two studies: 1. The maintenance study will be conducted in patients not progressing to a first line chemotherapy plus trastuzumab. 2. The 2nd line study will be conducted in patients progressing to a first line chemotherapy plus trastuzumab.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Nov 2007

Typical duration for phase_3

Geographic Reach
1 country

25 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

March 17, 2008

Status Verified

March 1, 2008

Enrollment Period

1.5 years

First QC Date

March 7, 2008

Last Update Submit

March 10, 2008

Conditions

Metastatic or Locally Advanced Breast Cancer

Keywords

trastuzumab optimization in breast cancer

Outcome Measures

Primary Outcomes (1)

  • progression free survival for maintenance study and overall survival for 2nd line study

    2.5 years

Secondary Outcomes (1)

  • overall survival for the maintenance study and progression free survival for the 2nd line study

    2.5 years

Study Arms (2)

A

EXPERIMENTAL

In the maintenance study: ARM A: maintenance of trastuzumab In the 2nd line study: ARM A: trastuzumab plus chemotherapy treatment

Drug: trastuzumab

B

NO INTERVENTION

In the maintenance study: ARM B: interruption of trastuzumab treatment In the 2nd line study: ARM B: chemotherapy alone

Interventions

trastuzumabDRUG

In the maintenance study trastuzumab will be administrated once every 3 weeks at the dose of 6 mg/kg by intravenous infusion over 90 minutes until progression of disease. In the 2nd line study, to accomplish the schedule of concomitant second line chemotherapy, trastuzumab will be given on a weekly (2 mg/kg) or a 3-weekly (6 mg/kg).

Also known as: Herceptin
A

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>18 years of age. Patients older of 70 years of age are eligible on the basis of an individual risk-benefit assessment by the investigator
  • Histologically confirmed breast cancer with locally advanced and/or metastatic disease
  • Over expression of HER2 (3+) as determined by IHC or amplification of HER2/c-erbB2 by FISH/CISH of the primary tumour or of a metastasis
  • Assessable disease. The presence of measurable disease is not needed for enrolment. Patients with bone lesions, ascites and pleural effusion as only sites of disease are considered eligible
  • Completion of a first line chemotherapy in association with trastuzumab given for at least 6 months for advanced disease. The last dose of trastuzumab should have to be given within 6 weeks prior to randomisation for treatments given with a 3 weekly schedule or within 3 weeks if a weekly schedule was used (only for maintenance study)
  • Progressive disease during or within 6 months from the completion of a first line chemotherapy plus trastuzumab for advanced disease or within 6 months from the completion of an adjuvant treatment for early disease (only for 2nd line study). Patients progressing more than 6 months after the completion of a first line trastuzumab-containing regimen should be re-treated with the previous regimen and included in 2nd line study after evidence of progression.
  • Signed written informed consent obtained prior to any study specific study procedures

You may not qualify if:

  • ECOG-PS \>2
  • Pregnant or lactating women. Women of childbearing potential must implement adequate contraceptive measures
  • Previous or current malignancies at other sites, with the exception of adequately treated in situ carcinoma of the cervix uteri, basal or squamous cell carcinoma of the skin, or other cancer curatively treated by surgery and with no evidence of disease for at least 5 years.
  • Baseline LVEF \<50% (measured by echocardiography or MUGA) performed within 4 weeks prior to randomisation. History of documented congestive heart failure, angina pectoris requiring antianginal medication, evidence of transmural infarction ECG, poorly controlled hypertension (systolic \> 180 mmHg or diastolic \> 100 mmHg); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias
  • Presence of CNS metastases, not amenable to curative therapy. Patients with previously treated CNS metastases must be asymptomatic and stable at radiological imaging from at least 3 months
  • Patients with dyspnoea at rest due to malignant or other disease, or who require supportive oxygen therapy. Patients with pre-existing lung disease or advanced pulmonary involvement may be at increased risk of serious toxicities with trastuzumab and should be evaluated carefully before entry into the study
  • Concomitant chemotherapy with anthracyclines, including liposomal drugs (only for 2nd line study)
  • Treatment with any investigational drug within 30 days before beginning of enrolment in the trial
  • History or presence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of trastuzumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Ospedale E. Profili

Fabriano, Ancona, 60044, Italy

RECRUITING

Humanitas Cliniche Gavazzeni

Bergamo, Bergamo, 24125, Italy

NOT YET RECRUITING

Azienda Ospedaliera Treviglio- Caravaggio

Treviglio, Bergamo, 24047, Italy

NOT YET RECRUITING

Policlinico Sant'Orsola - Malpighi

Bologna, Bologna, 40138, Italy

NOT YET RECRUITING

Ospedale Sant'Orsola Fatebenefratelli

Brescia, Brescia, 25122, Italy

NOT YET RECRUITING

Ospedale A. Perrino

Brindisi, Brindisi, 72021, Italy

NOT YET RECRUITING

Policlinico Universitario

Monserrato, Cagliari, 09042, Italy

NOT YET RECRUITING

Azienda Ospedaliera Sant' Anna

Como, Como, 22100, Italy

NOT YET RECRUITING

Azienda Ospedaliera Istituti Ospitalieri

Cremona, Cremona, 26100, Italy

NOT YET RECRUITING

Ospedale Alessandro Manzoni

Lecco, Lecco, 23900, Italy

NOT YET RECRUITING

Azienda Ospedaliera di Melegnano - Presidio Ospedaliero di Gorgonzola

Gorgonzola, Milano, 20069, Italy

NOT YET RECRUITING

Ospedale Fatebenefratelli e Oftalmico

Milan, MIlano, 20121, Italy

NOT YET RECRUITING

Fondazione San Raffaele del Monte Tabor

Milan, MIlano, 20133, Italy

NOT YET RECRUITING

Istituto Europeo di Oncologia

Milan, Milano, 20141, Italy

NOT YET RECRUITING

Azienda Ospedaliera San Paolo

Milan, Milano, 20142, Italy

NOT YET RECRUITING

Istituto Clinico Humanitas

Rozzano, Milan, 20089, Italy

RECRUITING

Azienda Ospedaliero-Universitaria di Parma

Parma, Parma, 43100, Italy

NOT YET RECRUITING

Azienda Ospedaliera Ospedale San Salvatore

Pesaro, Pesaro - Urbino, 61100, Italy

NOT YET RECRUITING

Ospedale Santa Croce

Fano, Pesaro-Urbino, 61032, Italy

NOT YET RECRUITING

Ospedale Misericordia e Dolce - USL 4

Prato, Prato, 59100, Italy

NOT YET RECRUITING

Dipartimento Oncologico USL 7 Siena

Siena, Siena, 53100, Italy

NOT YET RECRUITING

Ospedale E. Morelli

Sondalo, Sondrio, 23035, Italy

NOT YET RECRUITING

Ospedale Civile di Sondrio

Sondrio, Sondrio, 23100, Italy

NOT YET RECRUITING

Azienda Ospedaliera Busto Arsizio - Presidio ospedaliero Saronno

Saronno, Varese, 21047, Italy

NOT YET RECRUITING

Ospedale "Di Circolo e Fonadazione Macchi"

Varese, Varese, 21100, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Armando Santoro, MD

    Istituto Clinico Humanitas

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Irene Floriani, PhD

CONTACT

+390239014695floriani@marionegri.it

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2008

First Posted

March 17, 2008

Study Start

November 1, 2007

Primary Completion

May 1, 2009

Study Completion

April 1, 2011

Last Updated

March 17, 2008

Record last verified: 2008-03

Locations

IT(25)