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Comparison of the effect of letrozole and neoadjuvant cheotherapy with chemotherapy alone on clinical response in advanced hormonal breast cancer

Protocol summary

Study aim
Effect of letrozole in combination with neoadjuvant chemotherapy on positive hormone breast cancer.
Design
In this randomized controlled trial, a randomized, control group of 48 women with invasive breast cancer in the IIA to IIIC (T1-4, N0-3, M0), hormone receptor positive and negative HER2, Will be selected. Patients are randomly selected and divided into intervention and control groups. In the intervention group, hormone therapy added to chemotherapy, and control group given only chemotherapy. After completion of treatment, the clinical response, size of the breast and axillary lymph nodes, are evaluated by touch and then calipers. Ultrasonography is also repeated, and the patient is referred for surgery. The pathologic response rate is also assessed on post-surgical specimens.
Settings and conduct
Before the treatment, the complete physical examination is performed, the size of the breast mass and the axillary lymph nodes is measured using calipers and ultrasound. Chemotherapy with hormone therapy in the intervention group and chemotherapy alone in the control group according to The standard protocol starts. At the end of each cycle, breast and axillary is examined and the possible side effects of the treatment are evaluated. At the end of the chemotherapy, a clinical evaluation is performed with physical exam and ultrasonography, and after surgery pathologic response is evaluate. The location of the study is a university-affiliated medical center and private office.
Participants/Inclusion and exclusion criteria
Entry criteria: Patients with advanced advanced hormone breast cancer, aged> 18 years, lack of chemotherapy Exit criteria: Pregnancy Lactation, history of thromboembolic events in the patient, history of osteoporotic fractures
Intervention groups
Letrozole and chemotherapy in patients group, control group only receives chemotherapy.
Main outcome variables
The response rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181224042091N1
Registration date: 2019-02-27, 1397/12/08
Registration timing: prospective

Last update: 2019-02-27, 1397/12/08
Update count: 0
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
Zahra Mozaheb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3833 2711
Email address
mozahebz@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-01, 1397/12/10
Expected recruitment end date
2020-10-31, 1399/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of letrozole and neoadjuvant cheotherapy with chemotherapy alone on clinical response in advanced hormonal breast cancer
Public title
Evaluation of the effect of hormone therapy in breast cancer before surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
female with invasive breast cancer with positive hormone receptor and negative HER2 proven in pathology Clinical Phase IIA to IIIC (T1-4, N0-3, M0) Age more than 18 years Good performance ((ECOG: 0-1 No history of previous chemotherapy It is a conscientious informed consent
Exclusion criteria:
Pregnancy / Breastfeeding Liver cirrhosis History of thromboembolic events in the patient History of osteoporotic fractures Patient's lack of cooperation in correct implementation of the treatment process in accordance with the recommended guidelines
Age
From 18 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 48
Actual sample size reached: 48
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Mashhad University of Medical Sciences
Street address
Daneshgah st, ghorashi building,Research and Technology Deputy
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2018-12-11, 1397/09/20
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1397.457

Health conditions studied

1

Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast, endocrine therapy, neoadjuvant

Primary outcomes

1

Description
Clinical response rate
Timepoint
Clinical examination before and after treatment of Neo-adjuvant
Method of measurement
clinical examination and Sonography

Secondary outcomes

1

Description
pathologic response
Timepoint
after surgery
Method of measurement
pathologic response rate

Intervention groups

1

Description
Intervention group: Neoadjuvant patients treated with doxorubicin chemotherapy (60mg / m2) and cyclophosphamide (2600mg / m 2) every 2 weeks for 4 cycles, followed by paclitaxol (175mg / m 2) every 2 weeks for 4 cycles, and letrozole 1 per day , Patient with pre-menopausal zoladex 3.6 mg every 28 days of subcutaneous administration 2 weeks before treatment.
Category
Treatment - Drugs

2

Description
Control group: Only chemotherapy is given.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam-Raza hospital
Full name of responsible person
Zahra Mozaheb
Street address
Imam Reza hospital,Imam Reza square،Ebnesina St,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 8818
Email
Mozahebz@mums.ac.ir
Web page address
http://www.mums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi phd
Street address
Deputy of Research and Technology of the Mashhad University of Medical Science, opposite University of Ave. 18, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Mozaheb
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Hematology- Oncology department,Imam Reza hospital، Imam reza square,
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3859 8818
Email
Mozahebz@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra mozaheb
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
Hematology Oncology department, Imam Reza hospital, imam reza square
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 38598818
Email
Mozahebz@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra mozaheb
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Hematology
Street address
hematology oncology department،Imam Reza hospital, Imam Reza square, Ebnesina St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 38598818
Email
Mozahebz@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
General information of patients and the main outcome and analyzed data
When the data will become available and for how long
After completing sample size
To whom data/document is available
People working at university centers
Under which criteria data/document could be used
In the case of access, they do not have any analysis and interpretation before the article is published
From where data/document is obtainable
Email:mozahebz@mums.ac.ir
What processes are involved for a request to access data/document
After requesting and reasoning, the need for this information and how to use this information are available within 1 week, if available.
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