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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
Sponsor:
Information provided by (Responsible Party):
Jinsong Lu, RenJi Hospital

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.


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

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Drug: Paclitaxel
Other Name: Taxol
Drug: Cisplatin
Experimental: GnRHa
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
Drug: Paclitaxel
Other Name: Taxol
Drug: Cisplatin Drug: Gonadotropin-releasing hormone agonist
Goserelin 3.6 mg q28d or Leuprolide 11.25 mg q3m
Experimental: letrozole
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
Drug: Paclitaxel
Other Name: Taxol
Drug: Cisplatin Drug: Letrozole



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. regional recurrence free survival (RRFS) [ Time Frame: 5 years ]
    RRFS is defined as the time period between registration and first event

  4. local recurrence free survival (LRFS) [ Time Frame: 5 years ]
    LRFS is defined as the time period between registration and first event

  5. overall survival (OS) [ Time Frame: 5 years ]
    OS is defined as the time period between registration and first event

  6. distant-disease- free survival (DDFS) [ Time Frame: 5 years ]
    DDFS is defined as the time period between registration and first event

  7. 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

  8. serum markers [ Time Frame: Pre-treatment and/or surgical ]
    Changes in the angiogenic serum markers(mirRNA, lncRNA, cirRNA), measured at diagnosis and surgery

  9. molecular markers [ Time Frame: Pre-treatment and/or surgical ]
    Pre-treatment and surgical expression of molecular markers (LHRHa receptor, EGFR,PD-L1)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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 N0-2M0;
  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.

Information from the National Library of Medicine

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


Contacts
Contact: Jinsong Lu, MD lujjss@163.com

Locations
China, Hebei
HanDan Central Hospital Recruiting
Handan, Hebei, China, 056001
Contact: Yinzhou Zhang, MD         
China, Hunan
The First Affiliated Hospital of University of South China Recruiting
Hengyang, Hunan, China, 421001
Contact: Hongguang Liu, MD         
China, Jiangsu
The second people's hospital of Kunshan city Recruiting
Kunshan, Jiangsu, China, 215300
Contact: Bei Gu, MD         
China, Shanghai
Zhongshan Hospital Recruiting
Shanghai, Shanghai, China, 200032
Contact: Hongwei Zhang, MD         
Shanghai Jiaotong University School of Medicine, Renji Hospital Recruiting
Shanghai, Shanghai, China, 200127
Contact: Jinsong Lu, MD       lujjss@163.com   
Principal Investigator: Jinsong Lu, MD         
Yueyang hospital of integrated traditional Chinese and Western medine Recruiting
Shanghai, Shanghai, China, 200437
Contact: Xiaohong Xue, MD         
Armed Police Corps Hospital of Shanghai Recruiting
Shanghai, Shanghai, China, 201103
Contact: Yumei Ye, MD         
China, Zhejiang
Zhoushan hospital Recruiting
Zhoushan, Zhejiang, China, 316021
Contact: Jing Xu, MD         
Sponsors and Collaborators
RenJi Hospital

Responsible Party: Jinsong Lu, Director of Breast Surgery, RenJi Hospital
ClinicalTrials.gov Identifier: NCT02221999     History of Changes
Other Study ID Numbers: RenJiH-BC-002
First Posted: August 21, 2014    Key Record Dates
Last Update Posted: December 21, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Breast Neoplasms
Inflammatory Breast Neoplasms
Carcinoma, Ductal, Breast
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carcinoma, Ductal
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Paclitaxel
Letrozole
Albumin-Bound Paclitaxel
Cisplatin
Hormones
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists