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

Breast Cancer Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

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

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