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

Phase 2

Terminated

• Conditions: Estrogen Receptor Negative Neoplasm; Breast Cancer; HER-2 Positive Breast Cancer
• Interventions: Drug: nab-paclitaxel; Drug: Trastuzumab

• Registration Number: NCT02598310
• Lead Sponsor: Osaka Medical College

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Primary Completion: 2018-11-30
• Study Completion: 2018-11-30
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-26
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
nab-paclitaxel plus trastuzumab	nab-paclitaxel	Four 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 plus trastuzumab	Trastuzumab	Four 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.

Primary Outcome Measures

Name	Time	Method
Pathological complete response rate	Up to 12 weeks after the protocol therapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Osaka Medical College; 🇯🇵 Takatsuki, Osaka, Japan