Clinical Trials /

Study of Preoperative Chemotherapy for Early Triple Negative or HER2-positive Operable Breast Cancer

NCT02934828

Description:

The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Unknown status

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of Preoperative Chemotherapy for Early Triple Negative or HER2-positive Operable Breast Cancer
  • Official Title: A Randomized Study of Preoperative Chemotherapy or Postoperative Chemotherapy for Early Triple Negative or Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Operable Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: LC2014A04
  • NCT ID: NCT02934828

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
Neoadjuvant Chemotherapypreoperative chemotherapyNeoadjuvant chemotherapy
postoperative chemotherapyAdjuvant Chemotherapypostoperative chemotherapy

Purpose

The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS.

Detailed Description

      Neoadjuvant Chemotherapy (NCT) is a standard treatment of patients who hope breast-conserving
      therapy (BCT) with locally advanced inoperable breast cancer or large tumor size. it is
      beneficial to degrading the tumor stage, increasing the rate of surgical resection or the
      BCT.People who are pathological complete response (pCR) after NCT have an improvement in
      disease-free survival (DFS) and overall survival (OS), as well as better prognosis.
      Currently, breast cancer are entering into the era of molecular classification. Different
      molecular subtype of breast cancer showed a significant difference in prognosis; triple
      negative breast cancer (TNBC) and Her2 positive breast cancer are clinically relevant terms
      referring to a specific subtype of breast cancer with high malignant characteristics, early
      recurrence and metastasis, but sensitive to primary chemotherapy, proportion of which are 15%
      and 20% respectively. A meta analysis shows that TNBC and her2 positive breast cancer have a
      higher pCR than Luminal A/B, and the increasing in pCR rate means improvement in survival.

      The investigators previous study indicates that paclitaxel plus carboplatin with or without
      trastuzumab can improve pCR and prolong RFS in TNBC and her2 positive breast cancer Comparing
      to adjuvant chemotherapy.

      The investigators research aim to explores the optimal comprehensive treatment for TNBC and
      her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant
      treatment in improvement of RFS.
    

Trial Arms

NameTypeDescriptionInterventions
Neoadjuvant chemotherapyExperimentalNeoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve(AUC4) d2, q14d*6. HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year. RECIST is used once every 2 cycles. Patients will finish 6 cycles preoperative chemotherapy when CR/partial response(PR)/stable disease(SD) by RECIST without serious adverse events.
  • Neoadjuvant Chemotherapy
postoperative chemotherapyActive ComparatorPostoperative Chemotherapy:Standard chemotherapy regiments according to risk of recurrence: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH), EC/TC±H, and so on.
  • postoperative chemotherapy

Eligibility Criteria

        Inclusion Criteria:

          1. Invasive breast cancer confirmed by pathology evaluation of core biopsy

          2. Tumors must be ER/PgR status negative (immunohistochemistry(IHC) < 10%) and lack of
             HER2/neu overexpression or amplification as measured by local hospital pathology
             laboratory (IHC +/- fluorescence in situ hybridization (FISH) and IHC < 3+, and FISH <
             2.2) as described in the NCCN Guidelines

          3. Female between18 to 70 years of age, Eastern Cooperative Oncology Group(ECOG)
             Performance Status 0 or 1

          4. Early-stage TNBC or HER2 positive breast cancer according to the American Joint
             Committee on Cancer (AJCC) Staging Manual Clinical Stage IIA or IIB, Stage IIIA
             operable breast cancer

          5. Previously untreated

          6. Adequate hematologic function (absolute neutrophil count ≥ 1,500 cells/µL; hemoglobin
             > 9 g/dL, platelets > 100,000/µL.)

          7. Adequate hepatic function: total bilirubin ≤ upper limit of normal (ULN), serum
             albumin ≥≥ 3.0 g/dL, alanine aminotransferase and aspartate aminotransferase ≤ 1.5 x
             ULN.

        Exclusion Criteria:

          1. ICH:ER/PgR status positive

          2. HER2 positive breast cancer Patients with reduced ejection fraction <50% are not
             eligible

          3. Patients with second malignancies

          4. Patients with bilateral breast cancer

          5. allergic constitution
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Recurrence-Free Survival (RFS) of neoadjuvant and adjuvant treatment in TNBC and her2 positive breast cancer
Time Frame:5 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Chinese Academy of Medical Sciences

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