Breast CancerPhase 3NCT01998906

A Study of Herceptin (Trastuzumab) in Combination Chemotherapy in Women With Locally Advanced Breast Cancer

A Phase 3 study testing Trastuzumab, Doxorubicin and Paclitaxel in people with Breast Cancer, run by Hoffmann-La Roche at 36 sites in 6 countries.

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 study will assess the efficacy and safety of adding Herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (CMF) chemotherapy in women with locally advanced breast cancer and HER2/c-erbB-2 gene amplification. 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, Doxorubicin and Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 330 participants
Where: 36 sitesin 6 countries
Study dates: May 2002to Jul 2012
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, with locally advanced breast cancer.

Who cannot join

previous therapy for any invasive malignancy.

Trial locations and contacts

36 sites in 6 countries.

Country

City, postcode or hospital

36 sites in 6 countries

Italy15 sites

Study site
Bellunoi, Veneto, 32100
Study site
Bologna, Emilia-Romagna, 40138
Study site
Carpi, Emilia-Romagna, 41012
Study site
Castelfranco Veneto, Veneto, 31033
Study site
Milan, Lombardy, 20133
Study site
Mirano, Veneto, 30035
Study site
Pavia, Lombardy, 27100
Study site
Pisa, Tuscany, 56100
Study site
San Giovanni Rotondo, Apulia, 71013
Study site
Santorso, Veneto, 36014
Study site
Sassari, Sardinia, 07100
Study site
Trento, Trentino-Alto Adige, 38100
Study site
Udine, Friuli Venezia Giulia, 33100
Study site
Varese, Lombardy, 21100
Study site
Vicenza, Veneto, 36100

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Spain11 sites

Study site
Barcelona, Barcelona, 08022
Study site
Barcelona, Barcelona, 08035
Study site
Barcelona, Barcelona, 08041
Study site
Barcelona, Barcelona, 08907
Study site
Donostia / San Sebastian, Guipuzcoa, 20080
Study site
Jerez de la Frontera, Cadiz, 11407
Study site
Madrid, Madrid, 28041
Study site
Terrassa, Barcelona, 08221
Study site
Valencia, Valencia, 46009
Study site
Valencia, Valencia, 46010
Study site
Zaragoza, Zaragoza, 50009

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Russia7 sites

Study site
Kazan', 420029
Study site
Moscow, 107005
Study site
Moscow, 115478
Study site
Moscow, 117837
Study site
Moscow, 129128
Study site
Saint Petersburg, 197022
Study site
Saint Petersburg, 197758

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Austria1 site

Study site
Vienna, 1090

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Germany1 site

Study site
München, 80637

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Portugal1 site

Study site
Lisbon, 1099-023

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About this study

Official title: A Randomized, Open-label Study of the Effect of Paclitaxel, Doxorubicin, and CMF Neoadjuvant Chemotherapy, With and Without Herceptin, on Tumor Response in Women With HER2-positive Breast Cancer

Conditions: Breast Cancer
Being tested: Trastuzumab, Doxorubicin, Paclitaxel, CMF
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
8mg/kg IV on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycle 2 up a maximum of Cycle 17
DoxorubicinDrug
60 mg/m2 IV on Day 1 of Cycles 1 through 3
PaclitaxelDrug
150 mg/m2 IV on Day 1 of Cycles 1 through 3, followed by 175 mg/m2 IV on Day 1 of Cycles 4 through 7
CMFDrug
CMF: Cyclophosphamide (600 mg/m2 IV bolus), methotrexate (40 mg/m2 IV bolus), 5-fluorouracil (600 mg/m2 IV bolus) on Day 1 of Cycles 8 through 10

Study groups in NCT01998906
Study group	Role	What they receive
HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF	Experimental	Participants with HER2 proto-oncogene positive breast cancer (HER2+) were treated with trastuzumab 8 milligrams per kilogram (mg/kg), intravenous (IV), on Day 1 of Cycle 1, followed by 6 mg/kg, IV, on Day 1 of Cycle 2 to up a maximum of Cycle 17. Participants also received doxorubicin 60 mg/ square meter (m^2), IV, and paclitaxel 150 mg/m^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF: cyclophosphamide 600 mg/m^2, IV; methotrexate 40 mg/m^2, IV; and 5-fluorouracil 600 mg/m^2, IV, on Day 1 of Cycles 8 through 10. Receives: Drug: Trastuzumab; Drug: Doxorubicin; Drug: Paclitaxel; Drug: CMF
HER-2+ Doxorubicin/Paclitaxel/CMF	Active comparator	Participants with HER2 proto-oncogene positive breast cancer were treated with doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10. Receives: Drug: Doxorubicin; Drug: Paclitaxel; Drug: CMF
HER-2- Doxorubicin/Paclitaxel/CMF	Active comparator	Participants with HER2 proto-oncogene negative breast cancer were treated with doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10. Receives: Drug: Doxorubicin; Drug: Paclitaxel; Drug: CMF

What is being measured

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

Event-Free Survival (EFS) - Percentage of Participants With an Event
EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.
Measured: Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Event-Free Survival
The median time, in months, between randomization and date of documented occurrence of an EFS event.
Measured: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Event Free at 1 Year
Measured: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Event Free at 2 Years
Measured: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Event Free at 3 Years
Measured: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Secondary outcomes (8)

Percentage of Participants With Breast Pathological Complete Response (bpCR)
bpCR was defined as an absence of any invasive cancer cell of the primary tumor at the time of major surgery after neoadjuvant chemotherapy with and without trastuzumab.
Measured: BL, Day 1 of Cycles 1-10 (pre-surgery)
Percentage of Participants With Total Pathological Complete Response (tpCR)
tpCR was defined as a determination of bpCR and an absence of positive axillary nodes on pathology.
Measured: BL, Day 1 of Cycles 1-10 (pre-surgery)
Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Assessments were made based on objective tumor measurements of the lesions as recorded in the case report form. In inflammatory cancer, progressive disease (PD) was defined as progression of any of the 2 signs of breast edema and erythema. In non-inflammatory cancer, PD was concluded if either the investigator judged the participant as having progressed at any time prior to surgery, or there was at least a 20% increase in the sum of target lesions (TLs), any new lesion, or clear progression of any nontarget lesion (NTLs). Clear progression of any NTL was defined as at least a 20% increase in the sum of NTLs compared to BL. PR was defined as at least a 30% decrease from BL in the sum of the longest diameter of TLs. CR was defined as no PD as assessed by the investigator and complete disappearance of all lesions.
Measured: BL, Presurgery: Day 1 of Cycles 1-10
Overall Survival (OS) - Percentage of Participants With an Event
OS was defined as the time from the date of randomization to the date of the death due to any cause.
Measured: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Overall Survival
OS was defined as the time from the date of randomization to the date of the death due to any cause.
Measured: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Surviving at 1 Year
Measured: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Surviving at 2 Years
Measured: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Surviving at 3 Years
Measured: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Timeline

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

May 2002Jul 2012

First posted2 Dec 2013 (estimated)
Study startMay 2002
Primary completionJul 2012
Study completionJul 2012

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: 330 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01998906
Sponsor's protocol ID: MO16432
Status last verified: Oct 2014
First submitted: 25 Nov 2013
Last updated: 28 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?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label Study of the Effect of Paclitaxel, Doxorubicin, and CMF Neoadjuvant Chemotherapy, With and Without Herceptin, on Tumor Response in Women With HER2-positive Breast Cancer
ClinicalTrials.gov ID: NCT01998906
Acronym / sponsor ID: MO16432
Conditions: Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 330 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: May 2002
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 2 Dec 2013 (estimated)
Results: Posted 28 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: 3

Arm	Type	Receives
HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF	Experimental	Drug: Trastuzumab, Drug: Doxorubicin, Drug: Paclitaxel, Drug: CMFParticipants with HER2 proto-oncogene positive breast cancer (HER2+) were treated with trastuzumab 8 milligrams per kilogram (mg/kg), intravenous (IV), on Day 1 of Cycle 1, followed by 6 mg/kg, IV, on Day 1 of Cycle 2 to up a maximum of Cycle 17. Participants also received doxorubicin 60 mg/ square meter (m^2), IV, and paclitaxel 150 mg/m^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF: cyclophosphamide 600 mg/m^2, IV; methotrexate 40 mg/m^2, IV; and 5-fluorouracil 600 mg/m^2, IV, on Day 1 of Cycles 8 through 10.
HER-2+ Doxorubicin/Paclitaxel/CMF	Active comparator	Drug: Doxorubicin, Drug: Paclitaxel, Drug: CMFParticipants with HER2 proto-oncogene positive breast cancer were treated with doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10.
HER-2- Doxorubicin/Paclitaxel/CMF	Active comparator	Drug: Doxorubicin, Drug: Paclitaxel, Drug: CMFParticipants with HER2 proto-oncogene negative breast cancer were treated with doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 of Cycles 1 through 3. Followed by paclitaxel 175 mg/m^2, IV, alone on Day 1 of Cycles 4 through 7. Participants also received CMF on Day 1 of Cycle 8 through 10.

Who may qualify

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

Key inclusion criteria (1 listed)

female patients, >=18 years of age, with locally advanced breast cancer.

Key exclusion criteria (1 listed)

previous therapy for any invasive malignancy.

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: Herceptin8mg/kg IV on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycle 2 up a maximum of Cycle 17	Drug	HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF
Doxorubicin60 mg/m2 IV on Day 1 of Cycles 1 through 3	Drug	HER-2+ Doxorubicin/Paclitaxel/CMF, HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF, HER-2- Doxorubicin/Paclitaxel/CMF
Paclitaxel150 mg/m2 IV on Day 1 of Cycles 1 through 3, followed by 175 mg/m2 IV on Day 1 of Cycles 4 through 7	Drug	HER-2+ Doxorubicin/Paclitaxel/CMF, HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF, HER-2- Doxorubicin/Paclitaxel/CMF
CMFCMF: Cyclophosphamide (600 mg/m2 IV bolus), methotrexate (40 mg/m2 IV bolus), 5-fluorouracil (600 mg/m2 IV bolus) on Day 1 of Cycles 8 through 10	Drug	HER-2+ Doxorubicin/Paclitaxel/CMF, HER-2+ Trastuzumab, Doxorubicin/Paclitaxel/CMF, HER-2- Doxorubicin/Paclitaxel/CMF

Primary outcome

Event-Free Survival (EFS) - Percentage of Participants With an Event
Time frame: Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
EFS was defined as the time between randomization and date of documented occurrence of disease recurrence or progression (local, regional, distant or contralateral) or death due to any cause.
Event-Free Survival
Time frame: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
The median time, in months, between randomization and date of documented occurrence of an EFS event.
Percentage of Participants Event Free at 1 Year
Time frame: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Event Free at 2 Years
Time frame: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Event Free at 3 Years
Time frame: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

8 secondary outcomes

Percentage of Participants With Breast Pathological Complete Response (bpCR)
Time frame: BL, Day 1 of Cycles 1-10 (pre-surgery)
Percentage of Participants With Total Pathological Complete Response (tpCR)
Time frame: BL, Day 1 of Cycles 1-10 (pre-surgery)
Percentage of Participants Achieving Either Complete Response (CR) or Partial Response (PR) According to Modified Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Time frame: BL, Presurgery: Day 1 of Cycles 1-10
Overall Survival (OS) - Percentage of Participants With an Event
Time frame: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Overall Survival
Time frame: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Surviving at 1 Year
Time frame: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Surviving at 2 Years
Time frame: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter
Percentage of Participants Surviving at 3 Years
Time frame: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter

Results and safety

Results posted to the registry on 28 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
HER2+ Trastuzumab/Doxorubicin/Paclitaxel/CMF (HER2+TC)	115	1
HER2+ Doxorubicin/Paclitaxel/CMF (HER2+C)	116	2
HER2- Doxorubicin/Paclitaxel/CMF (HER2-C)	99	1

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

Time frame: Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter. Number. Unit: percentage of participants

Measure	HER2+ TC n = 115	HER2+ C n = 116	HER2- C n = 99
Value	40.0 (47.7 to NA)	50.9 (24.1 to NA)	42.4 (57.7 to NA)

Population analysed: The full analysis set (FAS) included all participants who were randomized in the main study or registered in the parallel observational arm.

Primary outcome: Event-Free Survival

Time frame: BL, Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter. Median (95% Confidence Interval). Unit: months

Measure	HER2+ TC n = 115	HER2+ C n = 116	HER2- C n = 99
Value	NA (47.7 to NA)	43.6 (24.1 to NA)	64.5 (57.7 to NA)

HER2+ TC vs HER2+ C: Hazard Ratio (HR): 0.65 (95% CI 0.44 to 0.96), p = 0.0275, Log Rank

Population analysed: FAS

Primary outcome: Percentage of Participants Event Free at 1 Year

Measure	HER2+ TC n = 115	HER2+ C n = 116	HER2- C n = 99
Value	89 (84 to 95)	82 (74 to 89)	80 (73 to 88)

Population analysed: FAS

Primary outcome: Percentage of Participants Event Free at 2 Years

Measure	HER2+ TC n = 115	HER2+ C n = 116	HER2- C n = 99
Value	73 (64 to 81)	61 (51 to 70)	69 (60 to 78)

Population analysed: FAS

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: BL, presurgery treatment Cycles 1-10, postsurgery Cycles 1-17, every 6 months thereafter for up to 60 months; yearly thereafter until primary analysis has taken place, after which serious adverse events were collected only if treatment related.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HER2+ TC	18 of 115 (15.7%)	113 of 115 (98.3%)	Not reported
HER2+ C	8 of 112 (7.1%)	112 of 112 (100%)	Not reported
HER2- C	9 of 99 (9.1%)	98 of 99 (99%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 chair

Hoffmann-La Roche

36 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Trastuzumab, Doxorubicin and Paclitaxel in people with Breast Cancer, run by Hoffmann-La Roche at 36 sites in 6 countries.

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 1 inclusion and 1 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 28 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 36 sites in Italy, Spain, Russia, Austria, Germany and 1 more country. 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 28 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?

Event-Free Survival (EFS) - Percentage of Participants With an Event (time frame: Baseline (BL), Presurgery: Day 1 (Cycles 1-7) and Days 1 and 8 (Cycles 8-10); Postsurgery: Day 1 (Cycles 1-17); every 6 months up to 60 months after last dose of study drug; yearly thereafter). The study lists 5 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 NCT01998906.

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 28 Oct 2014.