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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02598310
Other study ID # OMC BC-04
Secondary ID OMC BC-04
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 2015
Est. completion date November 30, 2018

Study information

Verified date August 2019
Source Osaka Medical College
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date November 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers No
Gender Female
Age group 20 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
nab-paclitaxel
nab-paclitaxel 260mg/m2 q3w
Trastuzumab
trastuzumab 6 mg/kg (8 mg/kg as the loading dose)

Locations

Country Name City State
Japan Osaka Medical College Takatsuki Osaka

Sponsors (1)

Lead Sponsor Collaborator
Osaka Medical College

Country where clinical trial is conducted

Japan, 

Outcome

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