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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00781612




Registration number
NCT00781612
Ethics application status
Date submitted
27/10/2008
Date registered
29/10/2008
Date last updated
20/08/2021

Titles & IDs
Public title
A Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies
Scientific title
An Open-Label, Multicenter Extension Study of Trastuzumab Emtansine Administered as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd-Sponsored Trastuzumab Emtansine Study
Secondary ID [1] 0 0
BO25430
Secondary ID [2] 0 0
TDM4529g
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neoplasm Metastasis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Docetaxel
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Pertuzumab
Treatment: Drugs - Trastuzumab
Treatment: Drugs - Trastuzumab Emtansine
Treatment: Drugs - Atezolizumab

Experimental: Trastuzumab Emtansine - Participants will receive trastuzumab emtansine either as a single agent or in combination with other anti-cancer therapy (atezolizumab, paclitaxel, trastuzumab and docetaxel). Participants will receive the same dose and schedule on Cycle 1, Day 1 at which it was given at the end of the parent study. Study drug will be administered in 21-day cycles or weekly, depending on the schedule used in the parent study. Participants will receive study treatment until disease progression or unacceptable toxicity.


Treatment: Drugs: Docetaxel
Docetaxel will be administered as per local prescribing information.

Treatment: Drugs: Paclitaxel
Paclitaxel will be administered as per local prescribing information.

Treatment: Drugs: Pertuzumab
Pertuzumab will be administered intravenously at a dose of 420 milligrams (mg) no more frequently than every 3 weeks (Q3W) (or as directed in the parent study protocol if less than Q3W).

Treatment: Drugs: Trastuzumab
Trastuzumab will be administered as per local prescribing information.

Treatment: Drugs: Trastuzumab Emtansine
Trastuzumab emtansine will be administered as intravenous (IV) infusion. Participants on weekly dosing schedule of trastuzumab emtansine in parent study, may switch to Q3W schedule as per the clinical judgment of the investigator. The starting dose of Q3W schedule must not exceed 3.6 milligrams per kilograms (mg/kg).

Treatment: Drugs: Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg by IV infusion every three weeks (Q3W)

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)
Primary outcome [2] 0 0
Percentage of Participants With Adverse Events Leading to Study Treatment Discontinuation or Dose Reduction
Timepoint [2] 0 0
Baseline up to 30 days after last dose of study drug administration (up to approximately 14 years)

Eligibility
Key inclusion criteria
- Completed single-agent trastuzumab emtansine or combination trastuzumab emtansine
treatment in the parent study or who continue to receive single-agent trastuzumab
emtansine or combination trastuzumab emtansine treatment at the time of the parent
study closure and received the last study drug dose within the 6 weeks (42 days) prior
to the first dose of study therapy on the extension study or Continue to receive
treatment in the control arm of study BO21976/TDM4450g (NCT00679341) at the time of
the parent study closure if the participant received the last dose of control arm
study drug within the 6 weeks (42 days) prior to the first dose of control arm study
therapy in the extension study

- Participants in the control arm from Study BO21976/TDM4450g whose disease progression
has occurred during the transition interval between the parent study and this
extension study may initiate trastuzumab emtansine treatment at the time of enrollment
into study TDM4529g (NCT00781612)

- Expectation by the investigator that the participant may continue to benefit from
additional single-agent trastuzumab emtansine or combination trastuzumab emtansine
treatment or Expectation of the investigator that the participant may continue to
benefit from control arm treatment as given in study BO21976/TDM4450g and at the time
of disease progression may benefit from single-agent trastuzumab emtansine treatment

- Women of childbearing potential and men with partners of childbearing potential, must
be willing to use a highly effective form of non-hormonal contraception or two
effective forms of non-hormonal contraception by the participants and/or partner, and
to continue the use of contraception for the duration of study treatment and for at
least 5 months after the last dose of atezolizumab (if applicable) or 7 months after
the last dose of trastuzumab emtansine or pertuzumab, whichever is later. Women must
refrain from donating eggs during this same period

- Male participants whose partners are pregnant should use condoms for the duration of
the pregnancy. Men must refrain from donating sperm during this same period
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine
treatment discontinuation in the parent study

- Ongoing SAEs from the parent study

- Progressive disease on single-agent trastuzumab emtansine or a trastuzumab
emtansine-containing regimen during the parent study or before starting the extension
study, with the exception of participants from study TDM4688g (NCT00943670) with early
disease progression who went on to receive pertuzumab + trastuzumab emtansine
treatment and have not experienced further disease progression on the combination
regimen

- Peripheral neuropathy of Grade greater than or equal to (>/=) 3 per the National
Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version
3.0, 4.0 or 5.0, as utilized in the parent study

- History of symptomatic congestive heart failure ([CHF]; New York Heart Association
[NYHA] Classes II-IV), ventricular arrhythmia requiring treatment, current unstable
angina, or history of myocardial infarction within 6 months prior to study entry

- Severe dyspnea at rest due to complications of advanced malignancy or current
requirement for continuous oxygen therapy

- Current severe, uncontrolled systemic disease (for example [e.g.] clinically
significant cardiovascular, pulmonary, or metabolic disease)

- Major surgical procedure or significant traumatic injury within 28 days prior to study
entry or anticipation of the need for major surgery during the course of study
treatment

- Current pregnancy or lactation

- History of receiving any investigational treatment or other systemic therapy directed
at controlling cancer (e.g., chemotherapy, trastuzumab, etc.) since the participant's
last study drug dose in the parent study

- History of hypersensitivity with previous trastuzumab emtansine or any agent used with
trastuzumab emtansine in the parent study, precluding further dosing

- Assessed by the investigator to be unable or unwilling to comply with the requirements
of the protocol

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Center - East Melbourne
Recruitment hospital [2] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Frankston
Recruitment postcode(s) [1] 0 0
3002 - East Melbourne
Recruitment postcode(s) [2] 0 0
3199 - Frankston
Recruitment outside Australia
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China
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Madrid
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Barcelona
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Sevilla
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Sweden
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Eskilstuna
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Switzerland
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Zürich
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Tainan
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Taipei City
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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United Kingdom
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Dundee
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Edinburgh
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Grimsby
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United Kingdom
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Lancaster
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London
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United Kingdom
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Manchester
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United Kingdom
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Middlesex
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United Kingdom
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Northwood
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United Kingdom
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Nottingham
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United Kingdom
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Poole
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United Kingdom
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Romford
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United Kingdom
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Swansea
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United Kingdom
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Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genentech, Inc.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a global, multicenter, open-label safety extension study. Participants receiving
single-agent trastuzumab emtansine or trastuzumab emtansine administered in combination with
other anti-cancer therapies in a Genentech / Roche-sponsored parent study who are active and
receiving benefit at the closure of parent study are eligible for continued treatment in this
study.
Trial website
https://clinicaltrials.gov/show/NCT00781612
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Genentech, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BO25430 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728 (U.S. and Canada)
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00781612