The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02748213




Registration number
NCT02748213
Ethics application status
Date submitted
20/04/2016
Date registered
22/04/2016
Date last updated
22/11/2016

Titles & IDs
Public title
A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
Scientific title
An Open-Label, Randomized Phase II Study of Herceptin (Trastuzumab), Taxotere (Docetaxel), and Xeloda (Capecitabine) in Combination, Versus Herceptin (Trastuzumab) Plus Taxotere (Docetaxel), in Patients With Advanced and/or Metastatic Breast Cancers That Overexpress HER2
Secondary ID [1] 0 0
MO16419
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Xeloda
Treatment: Drugs - Taxotere
Treatment: Drugs - Herceptin

Experimental: Herceptin + Taxotere - Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal.

Experimental: Herceptin + Taxotere + Xeloda - Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.


Treatment: Drugs: Xeloda
Participants will receive oral Xeloda, 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle.

Treatment: Drugs: Taxotere
Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm.

Treatment: Drugs: Herceptin
Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) - Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (=) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed =4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.
Timepoint [1] 0 0
Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Secondary outcome [1] 0 0
Percentage of Participants With Death or Disease Progression According to RECIST - Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as =20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported.
Timepoint [1] 0 0
Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Secondary outcome [2] 0 0
Progression-Free Survival (PFS) According to RECIST - Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as =20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
Timepoint [2] 0 0
Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)
Secondary outcome [3] 0 0
Percentage of Participants Who Died - The percentage of participants who died from any cause was reported.
Timepoint [3] 0 0
Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
Secondary outcome [4] 0 0
Overall Survival (OS) - OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
Timepoint [4] 0 0
Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)
Secondary outcome [5] 0 0
Duration of Response (DOR) According to RECIST - Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as =30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed =4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months.
Timepoint [5] 0 0
Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)

Eligibility
Key inclusion criteria
- Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not
amenable to curative therapy

- At least one measurable lesion according to RECIST

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Baseline left ventricular ejection fraction (LVEF) at least 50%
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant, lactating, or women of childbearing potential who are not surgically sterile
or not willing to use adequate contraceptive methods

- Previous treatment with Herceptin or other anti-HER therapies, or any previous
chemotherapy for advanced or metastatic disease

- Past medical history significant for any cardiac or central nervous system (CNS)
disorders

- Poor hematologic, renal, or hepatic function

- Chronic corticosteroid therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Brisbane
Recruitment hospital [3] 0 0
- Camperdown
Recruitment hospital [4] 0 0
- Geelong
Recruitment hospital [5] 0 0
- Melbourne
Recruitment hospital [6] 0 0
- Perth
Recruitment hospital [7] 0 0
- Southport
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Brisbane
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
3220 - Geelong
Recruitment postcode(s) [5] 0 0
3002 - Melbourne
Recruitment postcode(s) [6] 0 0
3181 - Melbourne
Recruitment postcode(s) [7] 0 0
6000 - Perth
Recruitment postcode(s) [8] 0 0
4215 - Southport
Recruitment outside Australia
Country [1] 0 0
Brazil
State/province [1] 0 0
Porto Alegre
Country [2] 0 0
Brazil
State/province [2] 0 0
Rio de Janeiro
Country [3] 0 0
Brazil
State/province [3] 0 0
Sao Paulo
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Costa Rica
State/province [7] 0 0
San Jose
Country [8] 0 0
Finland
State/province [8] 0 0
Turku
Country [9] 0 0
France
State/province [9] 0 0
Besancon
Country [10] 0 0
France
State/province [10] 0 0
Grenoble
Country [11] 0 0
France
State/province [11] 0 0
Marseille
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Pierre Benite
Country [14] 0 0
France
State/province [14] 0 0
Rennes
Country [15] 0 0
Greece
State/province [15] 0 0
Athens
Country [16] 0 0
Greece
State/province [16] 0 0
Heraklion
Country [17] 0 0
Greece
State/province [17] 0 0
Patras
Country [18] 0 0
Guatemala
State/province [18] 0 0
Guatemala City
Country [19] 0 0
Italy
State/province [19] 0 0
Legnago
Country [20] 0 0
Italy
State/province [20] 0 0
Noale
Country [21] 0 0
Italy
State/province [21] 0 0
Rozzano
Country [22] 0 0
Italy
State/province [22] 0 0
Trento
Country [23] 0 0
Italy
State/province [23] 0 0
Treviglio
Country [24] 0 0
Mexico
State/province [24] 0 0
Distrito Federal
Country [25] 0 0
Mexico
State/province [25] 0 0
Merida
Country [26] 0 0
Mexico
State/province [26] 0 0
Monterrey
Country [27] 0 0
Panama
State/province [27] 0 0
Panama City
Country [28] 0 0
Poland
State/province [28] 0 0
Gdansk
Country [29] 0 0
Poland
State/province [29] 0 0
Szczecin
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Lerida
Country [32] 0 0
Spain
State/province [32] 0 0
Sabadell, Barcelona
Country [33] 0 0
Spain
State/province [33] 0 0
Zaragoza
Country [34] 0 0
Sweden
State/province [34] 0 0
Karlstad
Country [35] 0 0
Sweden
State/province [35] 0 0
Västerås
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Ipswich
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Leeds
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Manchester
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Northwood
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Oxford
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Southampton
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Weston Super Mare

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin)
and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with
previously untreated HER2-positive advanced and/or metastatic breast cancer.
Trial website
https://clinicaltrials.gov/show/NCT02748213
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications