Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients (SHPD002)
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|ClinicalTrials.gov Identifier: NCT02221999|
Recruitment Status : Recruiting
First Posted : August 21, 2014
Last Update Posted : December 21, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Tubular Breast Cancer Mucinous Breast Cancer Invasive Ductal Breast Cancer Inflammatory Breast Cancer||Drug: Paclitaxel Drug: Cisplatin Drug: Gonadotropin-releasing hormone agonist Drug: Letrozole||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 2014|
|Estimated Primary Completion Date :||July 2018|
|Estimated Study Completion Date :||October 2022|
U.S. FDA Resources
Active Comparator: Chemotherapy only
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
Other Name: TaxolDrug: Cisplatin
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
Other Name: TaxolDrug: Cisplatin Drug: Gonadotropin-releasing hormone agonist
Goserelin 3.6 mg q28d or Leuprolide 11.25 mg q3m
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
Other Name: TaxolDrug: Cisplatin Drug: Letrozole
- pathological complete remission rate [ Time Frame: after 4 months preoperative treatment ]Pathological complete remission is defined as no invasive cancer in breast and axillary nodes.
- Number of Participants With Drug Related Treatment Adverse Events [ Time Frame: 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.
- Clinical and imaging response [ Time Frame: 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
- regional recurrence free survival (RRFS) [ Time Frame: 5 years ]RRFS is defined as the time period between registration and first event
- local recurrence free survival (LRFS) [ Time Frame: 5 years ]LRFS is defined as the time period between registration and first event
- overall survival (OS) [ Time Frame: 5 years ]OS is defined as the time period between registration and first event
- distant-disease- free survival (DDFS) [ Time Frame: 5 years ]DDFS is defined as the time period between registration and first event
- rate of tumor remission （RTR） [ Time Frame: after 2 cycles and 4 cycles during neoadjuvant therapy ]RTR is defined as the proportion of tumor remission per unit time
- serum markers [ Time Frame: Pre-treatment and/or surgical ]Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery
- molecular markers [ Time Frame: Pre-treatment and/or surgical ]Pre-treatment and surgical expression of molecular markers （LHRHa receptor, EGFR，PD-L1)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221999
|Contact: Jinsong Lu, MDfirstname.lastname@example.org|
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