Clinical Trials /

Weekly Paclitaxel and Cisplatin to Treat Hormone Receptor Positive and Triple Negative Breast Cancer Patients

NCT02221999

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

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

DrugSynonymsArms
PaclitaxelTaxolChemotherapy only
CisplatinChemotherapy only
Gonadotropin-releasing hormone agonistGnRHa
Letrozoleletrozole

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

NameTypeDescriptionInterventions
Chemotherapy onlyActive ComparatorPaclitaxel 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
  • Paclitaxel
  • Cisplatin
GnRHaExperimentalPaclitaxel 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
letrozoleExperimentalPaclitaxel 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 N0-2M0;

          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.
      
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:Recruiting
Lead Sponsor:RenJi Hospital

Last Updated

December 20, 2017