Breast CancerPhase 3NCT00448279

THOR Study: A Study of Continued Herceptin (Trastuzumab) in Combination With Second Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.

A Phase 3 study testing trastuzumab and Chemotherapy in people with Breast Cancer, run by Hoffmann-La Roche at 35 sites in Italy.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: trastuzumab and Chemotherapy
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 35 sitesItaly
Study dates: Apr 2007to Sep 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

female patients, >=18 years of age;
metastatic breast cancer;
HER2 overexpression (IHC 3+ and/or FISH positive);
disease progression during or after previous 1st line chemotherapy plus Herceptin;
scheduled to receive 2nd line chemotherapy.

Who cannot join

incompatibility with previous Herceptin therapy;
pregnancy.

Trial locations and contacts

35 sites in 1 country.

City, postcode or hospital

35 sites in 1 country

Italy35 sites

Study site
Avellino, 83100
Study site
Brescia, 25123
Study site
Candiolo, 10060
Study site
Carrara, 54033
Study site
Cona (Ferrara), 44124
Study site
Cosenza, 87100
Study site
Crotone - Kr, 88900
Study site
Fano, 61032
Study site
Florence, 50139
Study site
Frattaminore, 80026
Study site
Genova, 16132
Study site
Lecce, 73100
Study site
Livorno, 57100
Study site
Mantua, 46100
Study site
Meldola, 47014
Study site
Naples, 80131
Study site
Nocera Inferiore, 84014
Study site
Padova, 35128
Study site
Palermo, 90127
Study site
Pavia, 27100
Study site
Perugia, 06122
Study site
Pordenone, 33170
Study site
Potenza, 85100
Study site
Ragusa, 97100
Study site
Reggio Calabria, 89100
Study site
Rionero in Vulture, 85028
Study site
Roma, 00128
Study site
Roma, 00153
Study site
Salerno, 84131
Study site
San Giovanni Rotondo, 71013
Study site
Sassari, 07100
Study site
Sora, 03039
Study site
Taormina, 98030
Study site
Torino, 10125
Study site
Udine, 33100

Other trials in Italy

About this study

Official title: A Randomized, Open-label Study to Compare Progression-free Survival in Patients With HER2 Positive Metastatic Breast Cancer Who Continue or Discontinue Herceptin in Combination With 2nd Line Chemotherapy, Having Progressed on 1st Line Chemotherapy in Combination With Herceptin

This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition has progressed on 1st line chemotherapy plus Herceptin. Patients will be randomized either to continue or discontinue Herceptin treatment (2mg/kg iv infusion weekly, or 6mg/kg iv infusion every 3 weeks) while receiving 2nd line chemotherapy of the investigator's choice. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Conditions: Breast Cancer
Being tested: trastuzumab, Chemotherapy
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
2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks
ChemotherapyDrug
Schedule and dose at the investigator's discretion

Study groups in NCT00448279
Study group	Role	What they receive
Chemotherapy Alone	Active comparator	Chemotherapy, schedule and dose at the investigator's discretion. Receives: Drug: Chemotherapy
Chemotherapy, Trastuzumab	Experimental	Trastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion. Receives: Drug: trastuzumab; Drug: Chemotherapy

What is being measured

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

Progression-Free Survival (PFS) - Percentage of Participants With an Event
PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.
Measured: Baseline (BL) and every 8 weeks thereafter
Progression-Free Survival - Time to Event
The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.
Measured: BL and every 8 weeks thereafter

Secondary outcomes (4)

Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the last contact date at which the participant was known to be alive.
Measured: BL and every 8 weeks thereafter
Overall Survival - Time to Event
The median time from randomization to OS event. Participants were censored at the last contact date at which the participant was known to be alive.
Measured: BL and every 8 weeks thereafter
Percentage of Participants by Best Overall Response (BOR)
BOR was defined as the best objective response observed during the treatment period according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Complete response (CR): disappearance of all target lesions (TLs), with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 millimeters (mm). Partial response (PR): at least a 30 percent (%) decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. Progressive disease (PD): at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. Stable disease (SD) was defined as neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: BL and every 8 weeks thereafter
Percentage of Participants With a Best Overall Response of CR or PR
BOR was defined as the best objective response observed during the treatment period according to RECIST version 1.1. CR: disappearance of all TLs, with any pathological lymph nodes (whether target or non-target) having a reduction in short axis to less than 10 mm. PR: at least a 30% decrease in the sum of diameters of TLs, taking as reference the BL sum diameters. PD: at least a 20% increase in the sum of diameters of TLs, taking as a reference the smallest sum on study (this included the BL sum if that is the smallest on study). In addition to the relative increase in 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. SD: neither sufficient shrinkages to qualify for PR, nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: BL and every 8 weeks thereafter

Timeline

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

Apr 2007Sep 2010

First posted16 Mar 2007 (estimated)
Study startApr 2007
Primary completionSep 2010
Study completionSep 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies 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: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00448279
Sponsor's protocol ID: ML18742
Status last verified: Oct 2014
First submitted: 15 Mar 2007
Last updated: 24 Oct 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label Study to Compare Progression-free Survival in Patients With HER2 Positive Metastatic Breast Cancer Who Continue or Discontinue Herceptin in Combination With 2nd Line Chemotherapy, Having Progressed on 1st Line Chemotherapy in Combination With Herceptin
ClinicalTrials.gov ID: NCT00448279
Acronym / sponsor ID: ML18742
Conditions: Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 16 Mar 2007 (estimated)
Results: Posted 24 Oct 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Chemotherapy Alone	Active comparator	Drug: ChemotherapyChemotherapy, schedule and dose at the investigator's discretion.
Chemotherapy, Trastuzumab	Experimental	Drug: trastuzumab, Drug: ChemotherapyTrastuzumab, at the investigator's discretion, either 2 milligrams per kilogram (mg/kg) intravenous (i.v.) every 7 days or 6 mg/kg i.v. every 3 weeks. Chemotherapy, schedule and dose at the investigator's discretion.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

female patients, >=18 years of age;
metastatic breast cancer;
HER2 overexpression (IHC 3+ and/or FISH positive);
disease progression during or after previous 1st line chemotherapy plus Herceptin;
scheduled to receive 2nd line chemotherapy.

Key exclusion criteria (2 listed)

incompatibility with previous Herceptin therapy;
pregnancy.

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
trastuzumabAlso: Herceptin2mg/kg i.v. weekly, or 6mg/kg i.v. every 3 weeks	Drug	Chemotherapy, Trastuzumab
ChemotherapySchedule and dose at the investigator's discretion	Drug	Chemotherapy Alone, Chemotherapy, Trastuzumab

Primary outcome

Progression-Free Survival (PFS) - Percentage of Participants With an Event
Time frame: Baseline (BL) and every 8 weeks thereafter
PFS was defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Participants were censored at the last tumour evaluation.
Progression-Free Survival - Time to Event
Time frame: BL and every 8 weeks thereafter
The median time from randomization to PFS event. Participants were censored at the last tumour evaluation.

4 secondary outcomes

Overall Survival (OS) - Percentage of Participants With an Event
Time frame: BL and every 8 weeks thereafter
Overall Survival - Time to Event
Time frame: BL and every 8 weeks thereafter
Percentage of Participants by Best Overall Response (BOR)
Time frame: BL and every 8 weeks thereafter
Percentage of Participants With a Best Overall Response of CR or PR
Time frame: BL and every 8 weeks thereafter

Results and safety

Results posted to the registry on 24 Oct 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Chemotherapy Alone	29	0
Chemotherapy Plus (+) Trastuzumab	29	0

Primary outcome: Progression-Free Survival (PFS) - Percentage of Participants With an Event

Time frame: Baseline (BL) and every 8 weeks thereafter. Number. Unit: percentage of participants

Measure	Chemotherapy Alone n = 29	Chemotherapy + Trastuzumab n = 29
Value	58.6	58.6

Population analysed: ITT population

Primary outcome: Progression-Free Survival - Time to Event

Time frame: BL and every 8 weeks thereafter. Median (95% Confidence Interval). Unit: months

Measure	Chemotherapy Alone n = 29	Chemotherapy + Trastuzumab n = 29
Value	9.7 (5.5 to 18.9)	9.4 (6.7 to 12.0)

Population analysed: ITT population

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were recorded throughout the study. Drug-related serious AEs (SAEs) were collected, regardless of the time elapsed from last study treatment administration, even if the study had been closed.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Chemotherapy Alone	4 of 26 (15.4%)	26 of 26 (100%)	Not reported
Chemotherapy + Trastuzumab	1 of 28 (3.6%)	26 of 28 (92.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruitingObservational study
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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

35 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing trastuzumab and Chemotherapy in people with Breast Cancer, run by Hoffmann-La Roche at 35 sites in Italy.

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 2 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 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in Italy. 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?

Yes. Results are posted in the registry (first posted 24 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (PFS) - Percentage of Participants With an Event (time frame: Baseline (BL) and every 8 weeks thereafter). The study lists 2 primary outcomes in all. 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 NCT00448279.

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 24 Oct 2014.