Evaluation of clinical and histopathological efficacy of carboplatin and gemcitabine as second line neoadjuvant therapy in locally advanced breast cancer patients
This study is conducted in 50 subjects diagnosed with locally advanced breast cancer. Neoadjuvant chemotherapy in such tumors is basically used to reduce tumor size. The standard neoadjuvant regimen used, is the combination of doxorubicin, cyclophosphamide and paclitaxel. End point of neoadjuvant chemotherapy is reaching pathologic complete response (pCR). Generally regardless of the neoadjuvant regimen, pCR, considered as a prognostic factor for response to therapy, has been estimated to be 3-46% in different studies. Since pCR can be relevant to patients’ survival rate, efforts to increase this parameter can be beneficial for the patient. The aim of this study is to evaluate a second line neoadjuvant chemotherapy with the hope of increasing pCR in patients that have not reached a complete clinical response after the standard neoadjuvant regimen. Patient’s clinical status and sonography data are parameters used for evaluating clinical response. According to previous studies and data proving the effectiveness of other agents, carboplatin and gemcitabine with the estimated dose of AUC x 5 and 1g/m2 respectively have been selected as the second line regimen. Two to 3 cycles of second line therapy has been planned. Patients are randomly divided to control and intervention groups. The control group will be receiving the standard neoadjuvant chemotherapy and the intervention group will be treated with both standard and second line chemotherapy. The pathologist and statistical analyst will be blind towards studied groups of patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100136491N1
Registration date:2017-11-19, 1396/08/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Dena Firouzabadi
Name of organization / entity
Shiraz university of medical sciences-School of Pharmacy-Pharmacotherapy department
Country
Iran (Islamic Republic of)
Phone
+98 71 3242 4128
Email address
firouzabad@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
This study was approved in the Pharmaceutical Sciences Research Center of Shiraz School of Pharmacy and the budget will therefore be provided from the same center.
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of clinical and histopathological efficacy of carboplatin and gemcitabine as second line neoadjuvant therapy in locally advanced breast cancer patients
Public title
Studying the effect of addition of carboplatin and gemcitabine to standard therapy in improving response rate in breast cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Female patients; Diagnosed with locally advanced breast cancer; 18 to 60 years of age. Exclusion criteria: Evidence of metastasis; Inflammatory breast cancer; Abnormal kidney function (Serum creatinine > 1.5 mg/dl); Abnormal liver function (Bilirubin and Serum transaminase > 2xULN); Abnormal Bone marrow function (Abnormal hemoglobin, WBC and platelet count)
Age
From 18 years old to 60 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
50
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
The Ethics Comittee of Vice Chancellery of Research Affairs, Shiraz University of Medical Sciences
Street address
7th floor, Shiraz University of Medical Sciences central building, Next to the red crecent, Zand St.
City
Shiraz
Postal code
71345-1978
Approval date
2017-07-30, 1396/05/08
Ethics committee reference number
IR.SUMS.REC.1396.S372
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Complete pathologic response
Timepoint
At the end of second line chemotherapy and surgery for the intervention group (approximately 4-6 months after start of therapy) and at the end of standard chemotherapy and surgery for the control group (approximately 4 months after start of therapy)
Method of measurement
histopathologic evaluation of tumoral tissue of the breast
Secondary outcomes
1
Description
Renal adverse effects
Timepoint
Measured monthly for both groups and at the end of the second line chemotherapy in the intervention group (approximately 4-6 months after start of therapy) and at the end of the standard chemotherapy for the control group (approximately 4 months after start of therapy)
Method of measurement
Serum creatinine measurment and calculation of glomerular filteration rate (GFR)
2
Description
Bone marrow suppression
Timepoint
Measured monthly for both groups and at the end of the second line chemotherapy in the intervention group (approximately 4-6 months after start of therapy) and at the end of the standard chemotherapy for the control group (approximately 4 months after start of therapy)
Intervention group: Addition of second line neoadjuvant chemotherapy including Carboplatin intravenous injection with the dose of 5x target AUC and gemcitabine intravenous injection with the dose of 1 gram per square meter of body surface area, both for two to three cycles, to first line standard neoadjuvant chemotherapy.
Category
Treatment - Drugs
2
Description
Control group: Applying first line standard neoadjuvant chemotherapy including doxorubicin intravenous injection with the dose of 60 mg per square meter of body surface area along with cyclophosphamide intravenous injection with the dose of 600 mg per square meter of body surface area and paclitaxel intravenous injection with the dose of 175 mg per square meter of body surface area, all three applied for 4 cycles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Motahhari Specialty Sub-specialty Clinic affiliated to Shiraz University of Medical Sciences
Full name of responsible person
Dr.Alireza Rezvani, Hematologist Oncologist, Assistant professor Shiraz University of Medical Scienc