Clinical Trials /

Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer

NCT02598310

Description:

The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer
  • Official Title: Phase II Study of Neoadjuvant Nab-paclitaxel (PTX) and Trastuzumab for ER Negative and HER2 Positive Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: OMC BC-04
  • SECONDARY ID: OMC BC-04
  • NCT ID: NCT02598310

Conditions

  • Breast Cancer
  • Estrogen Receptor Negative Neoplasm
  • HER-2 Positive Breast Cancer

Interventions

DrugSynonymsArms
nab-paclitaxelAbraxanenab-paclitaxel plus trastuzumab
TrastuzumabHerceptinnab-paclitaxel plus trastuzumab

Purpose

The purpose of this study is to evaluate the efficacy and safety of nab-PTX and trastuzumab for ER negative and HER2 positive operable (tumor size of 3cm or less and N0) breast cancer.

Trial Arms

NameTypeDescriptionInterventions
nab-paclitaxel plus trastuzumabExperimentalFour cycles of nab-PTX 260 mg/m2 with trastuzumab 6 mg/kg (8 mg/kg as the loading dose). One year of adjuvant trastuzumab will be administrated. Anthracycline regimens may be administered by physician's choice for the case expected to have a high risk of recurrence based on the pathological findings of surgical specimen. Adjuvant endocrine therapy may be administrated for the case with weakly hormone-sensitive (1-9% of positive cells) tumor.
  • nab-paclitaxel
  • Trastuzumab

Eligibility Criteria

        Inclusion Criteria:

          1. Histologically confirmed invasive breast cancer

          2. Tumor size of 3cm or less and N0

          3. Hormone receptors have been identified as negative

          4. HER2 positive confirmed by IHC 3+ or FISH+

          5. LVEF > 50% by echocardiogram or MUGA

          6. Adequate EKG

          7. No prior treatment for breast cancer

          8. PS 0-1

          9. Required baseline laboratory data WBC > 4,000/mm3 and Neut > 2,000/mm3 PLT >
             100,000/mm3 Hb > 9.0g/dl AST and ALT < ULNx2.5 T-Bil < 1.5mg/dl Serum creatinin <
             1.5mg/dl

         10. Written informed consent

        Exclusion Criteria:

          1. With history of hypersensitivity reaction for important drug in this study

          2. With history of invasive breast cancer

          3. Bilateral invasive breast cancer

          4. Patients with medical conditions that renders them intolerant to primary chemotherapy
             and related treatment, including infection, diarrhea, intestinal paralysis, severe
             Diabetes Mellitus

          5. Positive for HBs antigen or HCV antibody

          6. With history of congestive heart failure, uncontrolled or symptomatic angina pectoris,
             arrhythmia or myocardial infarction, poorly controlled hypertension

          7. With severe edema

          8. With severe peripheral neuropathy

          9. With severe psychiatric disorder

         10. Pregnant or nursing women

         11. The case that is judged to be unsuitable for this study by physician
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:20 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathological complete response rate
Time Frame:Up to 12 weeks after the protocol therapy
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Disease free survival
Time Frame:Five years after the last patient enrolled
Safety Issue:
Description:
Measure:Objective response rate
Time Frame:Up to 6 weeks after the protocol therapy
Safety Issue:
Description:
Measure:Pathological response rate
Time Frame:Up to 12 weeks after the protocol therapy
Safety Issue:
Description:
Measure:Breast-conserving surgery rate
Time Frame:Up to 6 weeks after the protocol therapy
Safety Issue:
Description:
Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame:Up to 6 weeks after the protocol therapy
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Osaka Medical College

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