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The efficiency of endoradiotherapy with 177Lu-Trastuzumab in patients with resistant or relapsed HER2-positive breast cancer

Protocol summary

Study aim
The efficiency of endoradiotherapy with 177Lu-Trastuzumab in patients with resistant or relapsed HER2-positive breast cancer
Design
This is an interventional clinical trial with a single group design of 15 patients, performing between January 2022 and June 2023 that will be followed between treatment sessions.
Settings and conduct
Patients are selected and justified in the nuclear medicine center of the Persian Gulf hospital at Bushehr. The consent form is obtained and finally, the treatment will be performed with intravenous injection of 177Lu-Trastuzumab. After injection, patients will be undergone a whole-body scan for the assessment of radiotracer distribution. Six to eight weeks after the 177Lu-Trastuzumab therapy, the patients will be visited by oncologists and nuclear medicine physicians and if there was not any toxicity, the next treatment session will be performed
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age ≥18 years, Patients with confirmed HER2+ metastatic breast cancer using 68Ga-Trastuzumab PET/CT, Eastern Cooperative Oncology Group Performance Status (ECOG) ≤ 2, Having hematologic parameters as: (i) Absolute neutrophil count ≥ 1000 cells/mm3; (ii) Platelet count ≥ 100,000/mm3; (iii) Hemoglobin ≥ 9 g/dLSigned informed consent. Exclusion criteria: Pregnancy, Inability to provide written informed consent, Patients with known sensitivity or contraindication to Herceptin, Patients who had an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
Intervention groups
We are going to use a single group of patients to evaluate the efficiency of 177Lu-Trastuzumab in the treatment of HER2-positive breast cancer.
Main outcome variables
The proportion of patients who have a partial, stable (not-progressed), or complete response to therapy.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210612051548N3
Registration date: 2021-10-18, 1400/07/26
Registration timing: prospective

Last update: 2021-10-18, 1400/07/26
Update count: 0
Registration date
2021-10-18, 1400/07/26
Registrant information
Name
Majid Assadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 0361
Email address
assadipoya@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2023-06-21, 1402/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficiency of endoradiotherapy with 177Lu-Trastuzumab in patients with resistant or relapsed HER2-positive breast cancer
Public title
Endoradiotherapy with 177Lu-Trastuzumab in patients with HER2-positive breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥18 years Patients with confirmed HER2-positive breast cancer using 68Ga-Trastuzumab PET/CT Eastern Cooperative Oncology Group Performance Status (ECOG) ≤ 2 Having hematologic parameters as: (i) Absolute neutrophil count ≥ 1000 cells/mm3; (ii) Platelet count ≥ 100,000/mm3; (iii) Hemoglobin ≥ 9 g/dL Signed informed consent form
Exclusion criteria:
Pregnant woman Inability to provide written informed consent. Patients with known sensitivity or contraindication to Herceptin. The patient had an active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy. Patients have psychiatric illness/social situations that would interfere with compliance with study requirements
Age
From 18 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 15
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
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Bushehr University of Medical Science, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2021-06-27, 1400/04/06
Ethics committee reference number
IR.BPUMS.REC.1400.053

Health conditions studied

1

Description of health condition studied
Malignant breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Numbe of treated breast cancer patients
Timepoint
4-6 weeks after last treatment session
Method of measurement
Image-based response using 68Ga-Trastuzumab PET/CT

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In this study, the 177Lu-Trastuzumab PET/CT radiopharmaceutical is injected intravenously into 15 patients with breast cancers according to the 68Ga-Trastuzumab PET/CT. Then whole-body scan is performed at 24 hours, and 48 hours after injection to assess radiotracer distribution. Six to eight weeks after the 177Lu-Trastuzumab PET/CT therapy, the patients will be visited by oncologists and nuclear medicine physicians and if there was not any toxicity, the next treatment session will be performed.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Nuclear Medicine Center, Persian Gulf Hospital
Full name of responsible person
Majid Assadi
Street address
Persian Gulf Hospital, Taleghani Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Email
assadipoya@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Gholamreza Khamisipour
Street address
Vice-Chancellor for Research and Technology of Bushehr University of Medical Sciences, Salman-e-Farsi Blvd, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3345 0178
Fax
Email
khamisipourgholamreza@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr 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
Boushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
assadipoya@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
assadipoya@yahoo.com
Web page address
https://www.researchgate.net/profile/Majid-Assadi-2

Person responsible for updating data

Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Narges Jokar
Position
Research Instructor
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
narges.jokar69@gmail.com
Web page address
https://www.researchgate.net/profile/Narges-Jokar

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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