Description:
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.
Title
- Brief Title: Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients
- Official Title: A Prospective, Randomized, Open-label Comparison of Preoperative Weekly Paclitaxel and Cisplatin With or Without Endocrine Therapy in Patients With Operable Hormone Receptor Positive and Triple Negative Locally Advanced Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
RenJiH-BC-002
- NCT ID:
NCT02221999
Conditions
- Tubular Breast Cancer
- Mucinous Breast Cancer
- Invasive Ductal Breast Cancer
- Inflammatory Breast Cancer
Interventions
Drug | Synonyms | Arms |
---|
Paclitaxel | Taxol | Chemotherapy only |
Cisplatin | | Chemotherapy only |
Gonadotropin-releasing hormone agonist | | GnRHa |
Letrozole | | letrozole |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Chemotherapy only | Active Comparator | Paclitaxel injection 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle;Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles | |
GnRHa | Experimental | Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Gonadotropin-releasing hormone agonist (GnRHa)11.25 mg every 3 months or 3.6mg every month subcutaneously | - Paclitaxel
- Cisplatin
- Gonadotropin-releasing hormone agonist
|
letrozole | Experimental | Paclitaxel 80mg/m2,given on days1,8,15 and 22 of a 28-day cycle; Cisplatin 25mg/m2, given on days 1,8,and 15 of a 28-day cycle; for 4 cycles Letrozole 2.5mg/day | - Paclitaxel
- Cisplatin
- Letrozole
|
Eligibility Criteria
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.
Maximum Eligible Age: | 70 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | pathological complete remission rate |
Time Frame: | after 4 months preoperative treatment |
Safety Issue: | |
Description: | Pathological complete remission is defined as no invasive cancer in breast and axillary nodes. |
Secondary Outcome Measures
Measure: | Number of Participants With Drug Related Treatment Adverse Events |
Time Frame: | 4 months during neoadjuvant therapy |
Safety Issue: | |
Description: | 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. |
Measure: | Clinical and imaging response |
Time Frame: | 4 months during treatment |
Safety Issue: | |
Description: | 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 |
Measure: | regional recurrence free survival (RRFS) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | RRFS is defined as the time period between registration and first event |
Measure: | local recurrence free survival (LRFS) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | LRFS is defined as the time period between registration and first event |
Measure: | overall survival (OS) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | OS is defined as the time period between registration and first event |
Measure: | distant-disease- free survival (DDFS) |
Time Frame: | 5 years |
Safety Issue: | |
Description: | DDFS is defined as the time period between registration and first event |
Measure: | rate of tumor remission (RTR) |
Time Frame: | after 2 cycles and 4 cycles during neoadjuvant therapy |
Safety Issue: | |
Description: | RTR is defined as the proportion of tumor remission per unit time |
Measure: | serum markers |
Time Frame: | Pre-treatment and/or surgical |
Safety Issue: | |
Description: | Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery |
Measure: | molecular markers |
Time Frame: | Pre-treatment and/or surgical |
Safety Issue: | |
Description: | Pre-treatment and surgical expression of molecular markers (LHRHa receptor, EGFR,PD-L1) |
Details
Phase: | Phase 2/Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | RenJi Hospital |
Last Updated
March 14, 2019