Clinical Trials /

Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer

NCT03507465

Description:

Patients with ER+/HER2− breast cancer (presumably the luminal A subtype) could potentially avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2− breast cancer patients.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer
  • Official Title: Letrozole Plus Low-Dose Metronomic Capecitabine Versus EC-T (Epirubicin/Cyclophosphamide Followed by Docetaxel) as Neoadjuvant Therapy for ER+/HER2-negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: Guangdong General Hospital
  • NCT ID: NCT03507465

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Letrozole Plus Low-Dose Metronomic CapecitabineLetrozole Plus Low-Dose Metronomic Capecitabine
EC-TEC-T

Purpose

Patients with ER+/HER2− breast cancer (presumably the luminal A subtype) could potentially avoid the standard chemotherapy use. Letrozole Plus Low-Dose Metronomic Capecitabine may offer similar efficacy and less toxicity to standard chemotherapy in ER+/HER2− breast cancer patients.

Trial Arms

NameTypeDescriptionInterventions
Letrozole Plus Low-Dose Metronomic CapecitabineExperimental
  • Letrozole Plus Low-Dose Metronomic Capecitabine
EC-TActive Comparator
  • EC-T

Eligibility Criteria

        Inclusion Criteria:

        -women (age 18-70 years) with clinical T2-3 N0-1 M0 ER-positive (ER) allred score 4-8,and
        progesterone receptor-positive (PgR) ,HER2-negative adequate bone marrow reserve (WBC
        count, 3.5 *109/L; platelets, 100*109/L; hemoglobin, 10g/dL), hepatic function (AST/ALT
        bilirubin and alkaline phosphatase levels 1.25 the upper limit of normal value), and renal
        function (serum creatinine 1.25 the upper limit of normal value).

        Luminal A/ lymph node positive breast cancer or Luminal B breast cancer patients

        Exclusion Criteria:

          -  (a) male patients; (b) patients with inflammatory breast cancer or distant metastasis;
             (c) patients who were previously treated with chemotherapy, radiation therapy or prior
             treatment with AIs or antiestrogens for breast cancer; (d) patients with a second
             concomitant neoplasm; and (e) patients who could not meet the eligibility criteria.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:objective response rate
Time Frame:6 month
Safety Issue:
Description:objective response rate (ORR) measured by breast ultrasound monthly

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Guangdong General Hospital

Trial Keywords

  • letrozole
  • metronomic
  • capecitabine
  • neoadjuvant
  • chemotherapy
  • ER+/HER2-

Last Updated

April 24, 2018