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Trial registered on ANZCTR


Registration number
ACTRN12608000523303
Ethics application status
Approved
Date submitted
23/09/2008
Date registered
15/10/2008
Date last updated
29/12/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Study of combined neoadjuvant chemotherapy and letrozol in Postmenopausal Women with locally advanced breast cancer
Scientific title
A randomized Phase III Trial to evaluate the efficacy and safety of neoadjuvant chemotherapy +/- letrozol in Postmenopausal Women with locally advanced breast cancer
Secondary ID [1] 262132 0
New secondary ID. Please modify. no secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 3736 0
Condition category
Condition code
Cancer 4016 4016 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two arm randomized placebo controlled phase III study evaluating the efficacy and safety of the concurrent neoadjuvant chemotherapy and letrozol in patients with locally advanced breast cancer.
One hundred eligible women with pathologically proven locally advanced breast cancer were enrolled.
Study arm:
Chemotherapy consisting of a median 3 cycles (range 2-4 cycles) of CAF regimen [(intravenous Cyclophosphamide 600 mg/m2, doxorubicin 60 mg/m2 and 5-Fluorouracil (5-FU 600 mg/m2 )] every three weeks. Patients in this arm (n=50) receive daily oral letrozol 2.5 mg combined with neoadjuvant chemotherapy and up to the time of surgery [for a median time of nine weeks (range 6-12 weeks)]. All patients undergo modified radical mastectomy 2 weeks after the last cycle of chemotherapy.
Intervention code [1] 3451 0
Treatment: Drugs
Comparator / control treatment
Control arm:
Chemotherapy consisting of a 3 cycles of CAF regimen [(intravenous Cyclophosphamide 600 mg/m2, doxorubicin 60 mg/m2 and 5-Fluorouracil (5-FU) 600 mg/m2] every three weeks. Patients in this arm (n=50) receive daily oral placebo (sugar pills) combined with neoadjuvant chemotherapy and up to the time of surgery (for 12 weeks). All patients undergo modified radical mastectomy 2 weeks after the last cycle of chemotherapy.
The duration of intervention is 12 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 4917 0
Pathologic response rate is the primary end-point of the study.
According to the size of residual disease in the primary disease, a pathologic response will be assessed after the neoadjuvant treatment. Standard international union against cancer (UICC) criteria will be used for definition of pathologic response. Reduction of 50% or more in the product of the two maximum perpendicular diameters of breast mass is described as partial response and disappearance of tumor is taken as complete response. No change is defined as no response or reduction of mass less than 50%, and new lesion or more than 25% increasing in size is described as progression.
Timepoint [1] 4917 0
Response will be measured 2 weeks after the 3rd cycles of chemotherapy (i.e. 8 weeks after enrolling in the study)
Secondary outcome [1] 8114 0
Acute treatment-related toxicities will be measured by clinician and paraclinical assessment and graded according to the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC).
Timepoint [1] 8114 0
Acute treatment-related toxicities will be assessed at baseline, after each cycle of chemotherapy and weekly up to the time of surgery.
Secondary outcome [2] 8300 0
Acute treatment-related toxicities will be measured by clinician and paraclinical assessment and graded according to the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC).
Timepoint [2] 8300 0
Acute treatment-related toxicities will be assessed at baseline, after each cycle of chemotherapy and weekly up to the time of surgery.

Eligibility
Key inclusion criteria
1. Postmenopausal women with pathologically proven locally advanced breast cancer
2. No prior therapy
3. No clinical or imaging evidence of distant metastasis at the time of study enrollment
4. Karnofsky performance status = 70
5. Written informed consent
6. Normal or acceptable liver, kidney and bone marrow function
Minimum age
50 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Prior therapy
2. Clinical or imaging evidence of distant metastasis
3. Patients with a known contraindication or allergy to aromatase inhibitors
4. Patients with severe heart, cardiovascular, liver, renal, inflammatory intestinal or blood coagulation disorders,

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomization is performed by computer at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization by using a randomization table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/10/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 1232 0
Iran, Islamic Republic Of
State/province [1] 1232 0

Funding & Sponsors
Funding source category [1] 3916 0
University
Name [1] 3916 0
Shiraz University of Medical Sciences
Country [1] 3916 0
Iran, Islamic Republic Of
Primary sponsor type
Hospital
Name
Shiraz University of Medical Sciences
Address
Shiraz University of Medical Sciences, Shiraz 71936, Iran
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 3512 0
None
Name [1] 3512 0
Address [1] 3512 0
Country [1] 3512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5979 0
It is under reveiw by the Ethical Review Committee of Shiraz University of Medical Sciences
Ethics committee address [1] 5979 0
Ethical Review Committee of Shiraz University of Medical Sciences, Shiraz University of Medical Sciences, Shiraz 71936, Iran
Ethics committee country [1] 5979 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 5979 0
20/09/2008
Approval date [1] 5979 0
Ethics approval number [1] 5979 0

Summary
Brief summary
Breast cancer is the most common cause of cancer and cancer mortality in women worldwide. Despite early detection of breast cancer, locally advanced breast carcinomas account for a remarkable fraction of all breast carcinomas. The optimal management for these patients remains a major therapeutic challenge. Neoadjuvant chemotherapy is now considered the standard of care for these patients. Adjuvant and neoadjuvant endocrine therapy with aromatase inhibitors has an established role in the postmenopausal women with hormone receptor-positive invasive breast cancer. This two arm randomized clinical study aimed to evaluate the efficacy and safety of the combined neoadjuvant chemotherapy and letrozol in postmenopausal women with locally advanced breast carcinoma.
Trial website
www.sums.ac.ir
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28967 0
Address 28967 0
Country 28967 0
Phone 28967 0
Fax 28967 0
Email 28967 0
Contact person for public queries
Name 12124 0
Mohammad Mohammadianpanah
Address 12124 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 12124 0
Iran, Islamic Republic Of
Phone 12124 0
+98 711 6474320
Fax 12124 0
+98 711 6474320
Email 12124 0
[email protected]
Contact person for scientific queries
Name 3052 0
Mohammad Mohammadianpanah
Address 3052 0
Department of Radiation Oncology, Namazi Hospital, Shiraz University of Medical Sciences, Shiraz 71936-13311, Iran
Country 3052 0
Iran, Islamic Republic Of
Phone 3052 0
+98 711 6474320
Fax 3052 0
+98 711 6474320
Email 3052 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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