None listed
Conditions
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.
Interventions
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
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.
Sponsors
Shiraz University of Medical Sciences
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
50 Years to 85 Years
Healthy volunteers
No
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
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,
Outcome results
None listed