The objective of this randomized, double blind trial is to compare the efficacy of Herceptinl® and trastusumab is manufactured by Aryogen (HerZux) in neoadjuvant chemotherapy on the patients with breast cancer.In this study, 120 patients with HER2 positive breast cancer who meet the inclusion/exclusion criteria will be recruited and randomly assigned into two intervention or a control group. The patients in the intervention group will receive trastuzumab(Aryogen) and in the control group will receive Herceptin® as same dosage and form.Pathological response of breast cancer will be measured after the intervention and compared between the groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208116302N4
Registration date:2013-03-16, 1391/12/26
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-03-16, 1391/12/26
Registrant information
Name
Kamran Kamyar
Name of organization / entity
AryoGen Biopharma Company
Country
Iran (Islamic Republic of)
Phone
00982616102587،00982616101568
Email address
kamyark@aryogen.com
Recruitment status
Recruitment complete
Funding source
AryoGen Biopharma company
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Double blind، Randomized clinical trial of the efficacy of Aryogen Trastuzumab compared to Genentech/roche Trastuzumab in breast cancer
Public title
Comparative analysis of trastuzumab(Aryogen) with Herceptin®
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:older than 18 years; HER2 positive (3+) in IHC test or (2+) with positive FISH test; size of tumor more than 2cm; ECOG grade between 0-1; LVEF more than 55%; complete inform consent form
Exclusion criteria:metastatic breast cancer; bilaterally breast cancer; other neoplasms; bone marrow failure; renal failure; liver failure; heart failure; uncontroled hypertension; pregnancy during study or planning for pregnancy at the beginning of study. .
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research center of new technologies in biological science- Ibne Sina
pathological response of breast tumor according to sataloff criteria
Timepoint
18 weeks after beginning of neoadjuvant therapy
Method of measurement
pathological evaluation of breast biopsy by pathologist
Secondary outcomes
1
Description
Amplitude of probable hematologic side effects
Timepoint
once weekly after beginning of neoadjuvant therapy
Method of measurement
by laboratory tests
2
Description
Amplitude of probable fever side effect
Timepoint
once weekly after beginning of neoadjuvant therapy
Method of measurement
clinical,by phisician
3
Description
Amplitude of probable gastrointestinal side effects
Timepoint
once weekly after beginning of neoadjuvant therapy
Method of measurement
clinical and by laboratory tests
4
Description
Amplitude of probable Pulmonary side effects
Timepoint
once weekly after beginning of neoadjuvant therapy
Method of measurement
clinical,by phisician
5
Description
Amplitude of probable Cardiac side effects
Timepoint
once weekly after beginning of neoadjuvant therapy
Method of measurement
clinical,by phisician
6
Description
Amplitude of probable renal side effects
Timepoint
once weekly after beginning of neoadjuvant therapy
Method of measurement
clinical and by laboratory tests
7
Description
Amplitude of probable neurologic side effects
Timepoint
once weekly after beginning of neoadjuvant therapy
Method of measurement
clinical,by phisician
8
Description
Amplitude of probable allergic side effects
Timepoint
once weekly after beginning of neoadjuvant therapy
Method of measurement
clinical,by phisician
Intervention groups
1
Description
in interventional group:at first course of therapy:1-carboplatin 150mg(AUC>6) 2- docetaxel 75mg/kg 3- Trastuzumab (Aryogen) 8mg/kg. at next 5 course of therapy the same medicines are used but only Trastuzumab dose is 6mg/kg. intervals between courses of therapy are 3 weeks.
Category
Treatment - Drugs
2
Description
in control group:at first course of therapy: 1-carboplatin 150mg(AUC>6) 2- docetaxel 75mg/kg 3- Trastuzumab (Herceptin) 8mg/kg. at next 5 course of therapy the same medicines are used but only Herceptin dose is 6mg/kg. intervals between courses of therapy are 3 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research center of new technologies in biological science- Ibne Sina