Clinical Trial Results:
A double-blinded extension study to provide adjuvant treatment with single agent Herceptin® or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03
|
Summary
|
|
EudraCT number |
2018-000236-97 |
Trial protocol |
HU BG |
Global end of trial date |
25 Dec 2021
|
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
21 Oct 2022
|
First version publication date |
21 Oct 2022
|
Other versions |
|
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
|
|||
|
Trial identification
|
|||
Sponsor protocol code |
TX05-03E
|
||
|
Additional study identifiers
|
|||
ISRCTN number |
- | ||
US NCT number |
NCT04109391 | ||
WHO universal trial number (UTN) |
- | ||
|
Sponsors
|
|||
Sponsor organisation name |
Tanvex Biologics Corporation
|
||
Sponsor organisation address |
2030 Main Street, Suite 1050, CA 96214, Irvine, United States,
|
||
Public contact |
Jennifer Lai, Tanvex Biologics Corp., Tanvex Biologics Corporation, +1 949-483-8507, jennifer.lai@tanvex.com
|
||
Scientific contact |
Jennifer Lai, Tanvex Biologics Corp., Tanvex Biologics Corporation, +1 949-483-8507, jennifer.lai@tanvex.com
|
||
|
Paediatric regulatory details
|
|||
Is trial part of an agreed paediatric investigation plan (PIP) |
No
|
||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
|
||
|
Results analysis stage
|
|||
Analysis stage |
Final
|
||
Date of interim/final analysis |
25 Dec 2021
|
||
Is this the analysis of the primary completion data? |
Yes
|
||
Primary completion date |
25 Dec 2021
|
||
Global end of trial reached? |
Yes
|
||
Global end of trial date |
25 Dec 2021
|
||
Was the trial ended prematurely? |
No
|
||
|
General information about the trial
|
|||
Main objective of the trial |
• To collect safety, tolerability, and immunogenicity data for single agent Herceptin or TX05 in the adjuvant setting in subjects with early HER2-positive breast cancer who completed neoadjuvant treatment and primary resection in Protocol TX05-03.
• To collect safety, tolerability, and immunogenicity data following a single transition from neoadjuvant Herceptin to adjuvant TX05 in this population.
• To collect disease-free survival (DFS) and overall survival (OS) data in this population.
|
||
Protection of trial subjects |
Independent Ethics Committee or Institutional Review Board
Written approval of the protocol, the final informed consent document, relevant supporting material and subject recruitment information was obtained from the independent ethics committee (IEC)/institutional review board (IRB) of each site prior to study initiation.
Ethical Conduct of the Study
The Sponsor or designee implemented and maintained quality control and quality assurance procedures with written standard operating procedures (SOPs) to ensure that the study was conducted and data were generated, documented and reported in compliance with the protocol, International Council for Harmonisation (ICH) Good Clinical Practice (GCP), and applicable regulatory requirements.
This study was conducted in accordance with the provisions of the Declaration of Helsinki (October 1996) and all revisions thereof, and in accordance with Food and Drug Administration (FDA) regulations (code of federal regulations [CFR], Sections 312.50 and 312.56) and with ICH GCP (CPMP 135/95).
Subject Information and Consent
Informed consent was obtained from each subject before the subject was admitted to the study. The investigator was not to undertake any investigation specifically required for the clinical study until valid consent had been obtained. The consent form, with the date and time of day when it was signed, was to be retained by the investigator as part of the study records. A copy of the signed informed consent form was given to the subject.
|
||
Background therapy |
Concomitant medications administered for any reason were locally-approved and doses used and regimens were considered standard of care for the treated indication. Medications and (non-drug treatments) were monitored continuously by the investigator. Treatment for co-morbidities, disease signs and symptoms and treatment-emergent adverse events (TEAEs) were provided as necessary in the judgment of the investigator. Supportive care included premedication with antiemetics to limit study drug-related nausea and vomiting. Subjects could receive prophylaxis of treatment-induced diarrhea. Anti-inflammatory or narcotic analgesics were offered as needed. Prophylactic use of hematopoietic growth factors to support neutrophil or platelet counts according to local standard of care was permitted during this study. Subjects who entered the study on stable doses of erythropoietin or darbepoietin could continue this treatment, and subjects could start either drug during the study at the discretion of the investigator. Subjects with neutropenic fever or infection were treated promptly and could receive therapeutic colony-stimulating factors if appropriate. Packed red blood cell and platelet transfusions were administered as clinically indicated. All concomitant medications and treatments were to be recorded in the subject’s source documents and entered into the eCRF, available during study monitor visits, and included in SAE reports. Surgery during study participation to manage breast cancer lesions other than definitive surgery for the targeted tumor lesion post-neoadjuvant therapy was discouraged unless medically necessary in the judgment of the investigator. In this case, the subject was to be discontinued from the study prior to the surgical procedure. In such cases, the EOS/ET Visit was to be completed. No other investigational drug was to be used during treatment on this protocol, and concurrent participation in another clinical study was not allowed. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
20 Aug 2019
|
||
Long term follow-up planned |
No
|
||
Independent data monitoring committee (IDMC) involvement? |
No
|
||
|
Population of trial subjects
|
|||
Number of subjects enrolled per country |
|||
Country: Number of subjects enrolled |
Belarus: 15
|
||
Country: Number of subjects enrolled |
Chile: 7
|
||
Country: Number of subjects enrolled |
Georgia: 16
|
||
Country: Number of subjects enrolled |
India: 41
|
||
Country: Number of subjects enrolled |
Mexico: 14
|
||
Country: Number of subjects enrolled |
Peru: 26
|
||
Country: Number of subjects enrolled |
Philippines: 9
|
||
Country: Number of subjects enrolled |
Russian Federation: 139
|
||
Country: Number of subjects enrolled |
Ukraine: 70
|
||
Country: Number of subjects enrolled |
Hungary: 1
|
||
Worldwide total number of subjects |
338
|
||
EEA total number of subjects |
1
|
||
Number of subjects enrolled per age group |
|||
In utero |
0
|
||
Preterm newborn - gestational age < 37 wk |
0
|
||
Newborns (0-27 days) |
0
|
||
Infants and toddlers (28 days-23 months) |
0
|
||
Children (2-11 years) |
0
|
||
Adolescents (12-17 years) |
0
|
||
Adults (18-64 years) |
266
|
||
From 65 to 84 years |
72
|
||
85 years and over |
0
|
||
|
|||||||||||||||||||||||||||||||||||||||||
|
Recruitment
|
|||||||||||||||||||||||||||||||||||||||||
Recruitment details |
Females ≥ 18 years of age Completed neoadjuvant treatment (regardless of treatment arm) in the TX05/ Herceptin neoadjuvant study. Successfully underwent surgical resection of their primary tumor with no evidence of residual disease (as determined by local assessment) and no other adjuvant therapy, other than trastuzumab, was planned. | ||||||||||||||||||||||||||||||||||||||||
|
Pre-assignment
|
|||||||||||||||||||||||||||||||||||||||||
Screening details |
A CT scan or MRI (only if CT scan cannot be performed) of the chest, abdomen, and pelvis was required at Screening for all subjects. Depending on the adequacy for evaluation of disease, a combination of CT without contrast had to most often be used. Final tumor assessment at the EOS/ET Visit included repeat CT scan or MRI. | ||||||||||||||||||||||||||||||||||||||||
|
Pre-assignment period milestones
|
|||||||||||||||||||||||||||||||||||||||||
Number of subjects started |
344 [1] | ||||||||||||||||||||||||||||||||||||||||
Number of subjects completed |
338 | ||||||||||||||||||||||||||||||||||||||||
|
Pre-assignment subject non-completion reasons
|
|||||||||||||||||||||||||||||||||||||||||
Reason: Number of subjects |
Screening failure: 5 | ||||||||||||||||||||||||||||||||||||||||
Reason: Number of subjects |
Not assigned: 1 | ||||||||||||||||||||||||||||||||||||||||
| Notes [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: In total, 344 subjects were screened, of which 6 subjects were considered screen failures. All of the 338 randomized subjects initiated protocol treatment. Of those subjects who initiated protocol treatment, 175 subjects received TX05 only, 82 subjects received Herceptin only and 81 subjects transitioned from Herceptin to TX05. |
|||||||||||||||||||||||||||||||||||||||||
|
Period 1
|
|||||||||||||||||||||||||||||||||||||||||
Period 1 title |
Treatment Period (overall period)
|
||||||||||||||||||||||||||||||||||||||||
Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
|
||||||||||||||||||||||||||||||||||||||||
Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||||||
Roles blinded |
Investigator, Subject | ||||||||||||||||||||||||||||||||||||||||
|
Arms
|
|||||||||||||||||||||||||||||||||||||||||
Are arms mutually exclusive |
Yes
|
||||||||||||||||||||||||||||||||||||||||
|
Arm title
|
TX05 only | ||||||||||||||||||||||||||||||||||||||||
Arm description |
This is an extension study for subjects who were treated in the prior TX05/Herceptin neoadjuvant study (Protocol TX05-03) and successfully underwent surgical resection. Subjects were randomized to receive adjuvant treatment with single agent TX05 for up to 13 treatment cycles. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
TX05
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
TX05
|
||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Injection/infusion
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
TX05 8 mg/kg body weight was administered by 60-minute IV infusion on Day 1 of treatment Cycle 1 and thereafter
6 mg/kg body weight every 3 weeks until Cycle 13.
|
||||||||||||||||||||||||||||||||||||||||
|
Arm title
|
Herceptin Only | ||||||||||||||||||||||||||||||||||||||||
Arm description |
This is an extension study for subjects who were treated in the prior TX05/Herceptin neoadjuvant study (Protocol TX05-03) and successfully underwent surgical resection. Subjects were randomized to receive adjuvant treatment with single agent Herceptin for up to 13 treatment cycles. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Herceptin
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
Herceptin
|
||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Injection/infusion
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
Herceptin 8 mg/kg body weight was administered by 60-minute IV infusion on Day 1 of treatment Cycle 1 and thereafter 6 mg/kg body weight every 3 weeks until Cycle 13.
|
||||||||||||||||||||||||||||||||||||||||
|
Arm title
|
Herceptin/TX05 Transition | ||||||||||||||||||||||||||||||||||||||||
Arm description |
This is an extension study for subjects who were treated in the prior TX05/Herceptin neoadjuvant study (Protocol TX05-03) and successfully underwent surgical resection. Subjects were randomized to receive adjuvant treatment with single agent Herceptin or TX05 for up to 13 treatment cycles. 81 subjects transitioned from Herceptin to TX05. | ||||||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
TX05 or Herceptin
|
||||||||||||||||||||||||||||||||||||||||
Investigational medicinal product code |
TX05
|
||||||||||||||||||||||||||||||||||||||||
Other name |
|||||||||||||||||||||||||||||||||||||||||
Pharmaceutical forms |
Injection/infusion
|
||||||||||||||||||||||||||||||||||||||||
Routes of administration |
Intravenous use
|
||||||||||||||||||||||||||||||||||||||||
Dosage and administration details |
TX05 8 mg/kg body weight was administered by 60-minute IV infusion on Day 1 of treatment Cycle 1 and thereafter
6 mg/kg body weight every 3 weeks until Cycle 13.
|
||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Baseline characteristics reporting groups
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Treatment Period
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Subject analysis sets
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set title |
Safety Population
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set type |
Safety analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The safety analysis was carried with the safety population according to the treatment they actually received.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
|
End points reporting groups
|
|||
Reporting group title |
TX05 only
|
||
Reporting group description |
This is an extension study for subjects who were treated in the prior TX05/Herceptin neoadjuvant study (Protocol TX05-03) and successfully underwent surgical resection. Subjects were randomized to receive adjuvant treatment with single agent TX05 for up to 13 treatment cycles. | ||
Reporting group title |
Herceptin Only
|
||
Reporting group description |
This is an extension study for subjects who were treated in the prior TX05/Herceptin neoadjuvant study (Protocol TX05-03) and successfully underwent surgical resection. Subjects were randomized to receive adjuvant treatment with single agent Herceptin for up to 13 treatment cycles. | ||
Reporting group title |
Herceptin/TX05 Transition
|
||
Reporting group description |
This is an extension study for subjects who were treated in the prior TX05/Herceptin neoadjuvant study (Protocol TX05-03) and successfully underwent surgical resection. Subjects were randomized to receive adjuvant treatment with single agent Herceptin or TX05 for up to 13 treatment cycles. 81 subjects transitioned from Herceptin to TX05. | ||
Subject analysis set title |
Safety Population
|
||
Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety analysis was carried with the safety population according to the treatment they actually received.
|
||
|
||||||||||||||||
End point title |
Disease-Free Survival (DFS) [1] | |||||||||||||||
End point description |
Recurrence of Breast Cancer or a Diagnosis of a second primary cancer.
NOTE:
This is an extension trial and had no formal primary endpoint. The parameter (DFS) was regarded as of highest clinical relevance.
|
|||||||||||||||
End point type |
Primary
|
|||||||||||||||
End point timeframe |
Time from randomization in the neoadjuvant study TX05-03 to the documentation of a first failure, where a failure is the recurrence of breast cancer, a diagnosis of a second primary cancer.
|
|||||||||||||||
| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: This extension trial had no formal primary endpoint. No statistical analysis were performed for this end point. |
||||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||||||||
End point title |
Overall Survival (OS) | |||||||||||||||
End point description |
Overall survival.
|
|||||||||||||||
End point type |
Other pre-specified
|
|||||||||||||||
End point timeframe |
From randomization in the neoadjuvant study until death from any cause.
|
|||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||||||||
End point title |
Incidence of treatment-emergent adverse events (TEAEs) | |||||||||||||||
End point description |
Treatment emergent adverse event is defined as any AEs newly occurring on or after the first dose of study drug of study TX05-03E or severity becomes worse on or after the first dose of study drug of the study TX05-03E.
|
|||||||||||||||
End point type |
Other pre-specified
|
|||||||||||||||
End point timeframe |
From Day 1 of Cycle 1 of study treatment to EOS/ET week 45.
|
|||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||||||||
End point title |
Incidence of study drug related TEAEs | |||||||||||||||
End point description |
Treatment emergent adverse event is defined as any AEs newly occurring on or after the first dose of study drug of study TX05-03E or severity becomes worse on or after the first dose of study drug of the study TX05-03E.
|
|||||||||||||||
End point type |
Other pre-specified
|
|||||||||||||||
End point timeframe |
From Day 1 of Cycle 1 of study treatment to EOS/ET week 45.
|
|||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||||||||
End point title |
Incidence of serious AEs | |||||||||||||||
End point description |
Treatment emergent adverse event is defined as any AEs newly occurring on or after the first dose of study drug of study TX05-03E or severity becomes worse on or after the first dose of study drug of the study TX05-03E.
|
|||||||||||||||
End point type |
Other pre-specified
|
|||||||||||||||
End point timeframe |
From Day 1 of Cycle 1 of study treatment to EOS/ET week 45.
|
|||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||||||||
End point title |
Incidence of study drug related SAEs | |||||||||||||||
End point description |
Treatment emergent adverse event is defined as any AEs newly occurring on or after the first dose of study drug of study TX05-03E or severity becomes worse on or after the first dose of study drug of the study TX05-03E.
|
|||||||||||||||
End point type |
Other pre-specified
|
|||||||||||||||
End point timeframe |
From Day 1 of Cycle 1 of study treatment to EOS/ET week 45.
|
|||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||||||||
End point title |
Incidence of anti-drug antibodies (ADA) | |||||||||||||||
End point description |
Subjects with positive ADA.
|
|||||||||||||||
End point type |
Other pre-specified
|
|||||||||||||||
End point timeframe |
From prior to initiation of infusion of study drug at Cycle 6 week 15.
|
|||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||||||||
End point title |
Incidence of anti-drug antibodies (ADA) | |||||||||||||||
End point description |
Subjects with positive ADA
|
|||||||||||||||
End point type |
Other pre-specified
|
|||||||||||||||
End point timeframe |
From prior to initiation of infusion of study drug at EOS/ET week 45.
|
|||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||||||||
End point title |
Incidence of neutralizing antibodies (Nab) | |||||||||||||||
End point description |
Subjects with positive Nab.
|
|||||||||||||||
End point type |
Other pre-specified
|
|||||||||||||||
End point timeframe |
From prior to initiation of infusion of study drug at Cycle 6 week 15.
|
|||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
||||||||||||||||
End point title |
Incidence of neutralizing antibodies (Nab) | |||||||||||||||
End point description |
Subjects with positive Nab.
|
|||||||||||||||
End point type |
Other pre-specified
|
|||||||||||||||
End point timeframe |
From prior to initiation of infusion of study drug at EOS/ET week 45.
|
|||||||||||||||
|
||||||||||||||||
| No statistical analyses for this end point | ||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Timeframe for reporting adverse events |
From Day 1 of Cycle 1 of study treatment to EOS/ET week 45.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Adverse event reporting additional description |
Treatment emergent adverse event is defined as any AEs newly occurring on or after the first dose of study drug of study TX05-03E or severity becomes worse on or after the first dose of study drug of the study TX05-03E.
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Dictionary used for adverse event reporting
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
24.1
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Reporting groups
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Safety population TX05
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Patients on TX05 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Safety population Herceptin
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Patient on Herceptin | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Safety population Herceptin/ TX05 Transition
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group description |
Patients on Herceptin in main study and randomized to TX05 at the beginning of the extension period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| Not applicable | |||
