Inflammatory Breast Cancer, Invasive Ductal Breast Cancer, Mucinous Breast Cancer, Tubular Breast Cancer
Conditions
Brief summary
The investigators hypothesize that paclitaxel combined with cisplatin in a weekly-based regimen as neoadjuvant chemotherapy is effective and tolerable for locally advanced breast cancer. In patients with some sub-type advanced breast cancer, neo-adjuvant chemotherapy combined with endocrine therapy may improve the pathological remission rate. Premenopausal patients with triple negative breast caner and hormonal receptor positve breast cancer patients will be randominzed to have neoadjuvant chemotherapy combined with endocrine therapy or not.
Detailed description
In this trial, patients with ER and or PR positive breast cancer will be separately randomized to have chemotherapy or chemotherapy combined with endocrine therapy according to their menstrual status. Letrozole for the postmenopausal women and ovarian function suppression for the premenopausal women. Patients with triple negative breast cancer will be randomized to have neoadjuvant chemotherapy combined with ovarian function suppression if she is premenopausal. Postermenopausal patients with triple negative breast caner will only have neoadjuvant chemotherapy. Patients with Her2 overexpression can obtain anti-Her2 target therapy. This study has been amended to a 1:2 ratio to control and neoadjuvant chemotherapy combination of endocrine therapy.
Interventions
DRUGPaclitaxel
DRUGCisplatin
Goserelin 3.6 mg q28d or Leuprolide 11.25 mg q3m
DRUGLetrozole
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Women aged ≥18years and ≤70 years; 2. At least on measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST). Histologically confirmed invasive breast cancer, tumor size ≥2 cm, T2-4 N0-3M0; 3. ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER and/or PR positive was defined as \>1% stained cells.HER2-positive is defined as immuno-histochemistry (IHC) 3+ or the ratio of HER2 gene signals to chromosome 17 signals \>2.0 or HER2 gene copy \>6.0. 4. No prior systemic or loco-regional treatment of breast cancer; 5. Adequate bone marrow function:WBC≥4.0×109/L, Absolute neutrophil count（ANC）≥1.5×109/L, Platelets（PLT）≥100×109/L, Hemoglobin（Hb）≥90g/L;aspartate aminotransferase(AST),Alanine aminotransferase (ALT)≤1.5 upper normal limit (UNL), creatinine≤1.5 UNL, bilirubin≤1.5UNL; 6. No obvious main organs dysfunction.
Exclusion criteria
1. Unwilling or unable to use an acceptable method of contraception in 8 weeks (including 8 weeks) after final dose of test drug; 2. Patient is pregnant or breast feeding; 3. Inflammatory breast cancer and metastatic breast cancer; 4. Any evidence of sense or motor nerve disorders; 5. Patients with medical conditions taht indicate intolerant to neoadjuvant therapy, including uncontrolled cardiovascular disease, severe infection; 6. Any concurrent malignancy other than breast cancer; 7. Know severe hypersensitivity to any drugs in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pathological complete remission rate | after 4 months preoperative treatment | Pathological complete remission is defined as no invasive cancer in breast and axillary nodes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and imaging response | 4 months during treatment | To determine the response rates of the breast tumor and axillary nodes based on physical examination and imaging tests. (sonography, mammography, or MRI) after treatment |
| disease free survival (DFS) | 5 years | DFS is defined as the time in months from randomization until first occurrence of locoregional recurrence, distant metastasis, contralateral breast cancer, second primary tumor, or death from any cause. |
| regional recurrence free survival (RRFS) | 5 years | RRFS is defined as the time period between registration and first event |
| local recurrence free survival (LRFS) | 5 years | LRFS is defined as the time period between registration and first event |
| Number of Participants With Drug Related Treatment Adverse Events | 4 months during neoadjuvant therapy | Adverse events that occurred on or after initial treatment that were absent before treatment or worsened during the treatment period relative to the pretreatment state. |
| distant-disease- free survival (DDFS) | 5 years | DDFS is defined as the time period between registration and first event |
| rate of tumor remission （RTR） | after 2 cycles and 4 cycles during neoadjuvant therapy | RTR is defined as the proportion of tumor remission per unit time |
| serum markers | Pre-treatment and/or surgical | Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery |
| molecular markers | Pre-treatment and/or surgical | Pre-treatment and surgical expression of molecular markers （LHRHa receptor, EGFR，PD-L1) |
| overall survival (OS) | 5 years | OS is defined as the time period between registration and first event |
Countries
China
Outcome results
None listed