Evaluation of AryoTrust safety and adverse effects in Iranian HER2-positive breast cancer patients under adjuvant chemotherapy regimens
Design
The present study is a phase 4 clinical trial aimed to investigate 597 patients with non-metastatic HER2 positive breast cancer after treatment with adjuvant chemotherapy. Data collection is done through interviews, physical examination and adverse reactions which are recorded in specific notebooks. There are two notebooks, first notebook consists of cycles 1 to 3 and second notebook consists of cycles 4 to 9 and is completed in patients who can be followed after 3 trastuzumab administration, according to investigator’s decision.
Settings and conduct
The present study is conducted due to interview, physical examination and adverse reactions recording in notebooks. This phase 4 study is performed in Iran, on Iranian breast cancer patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients diagnosed with non-metastatic HER2 positive breast cancer after treatment with adjuvant chemotherapy (trastuzumab in combination with doxetaxel or paclitaxel weekly for 12 weeks or others regimens) who are candidates for trastuzumab maintenance therapy 6 mg/kg every 3 weeks for 12 months.
Exclusion criteria: Patients who received Herceptin, Patients who are not candidates for trastuzumab maintenance therapy after adjuvant chemotherapy.
Intervention groups
Trastuzumab maintenance therapy 6 mg/kg every 3 weeks for 12 months after treatment with adjuvant chemotherapy
Main outcome variables
AryoTrust safety and adverse effects
General information
Reason for update
Acronym
مطالعه پایش ایمنی داروی آریوتراست
IRCT registration information
IRCT registration number:IRCT20150303021315N16
Registration date:2019-11-24, 1398/09/03
Registration timing:registered_while_recruiting
Last update:2019-11-24, 1398/09/03
Update count:0
Registration date
2019-11-24, 1398/09/03
Registrant information
Name
Nassim Anjidani
Name of organization / entity
Orchid Pharmed
Country
Iran (Islamic Republic of)
Phone
+98 21 4347 3000
Email address
amini@orchidpharmed.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2020-03-18, 1398/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Post-marketing surveillance for evaluation of AryoTrust safety in Iranian HER2-positive breast cancer patients under adjuvant chemotherapy regimens
Public title
Evaluation of AryoTrust administration in treatment of breast cancer
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with non-metastatic HER2 positive breast cancer after treatment with adjuvant chemotherapy (trastuzumab in combination with doxetaxel or paclitaxel weekly for 12 weeks or others regimens) who are candidates for trastuzumab maintenance therapy 6 mg/kg every 3 weeks for 12 months
Exclusion criteria:
- Patients who received Herceptin
- Patients who are not candidates for trastuzumab maintenance therapy after adjuvant chemotherapy
Age
From 18 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
597
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Regional ethics committee of Mashhad university of medical sciences
Street address
Research chancellor, Mashhad University of Medical Sciences, 18th Daneshgah St., Daneshgah Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
91735951
Approval date
2017-11-15, 1396/08/24
Ethics committee reference number
IR.MUMS.fm.REC.1396.519
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50.919
ICD-10 code description
Malignant neoplasm of unspecified site of unspecified female breast