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.
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
Drug | Synonyms | Arms |
---|
nab-paclitaxel | Abraxane | nab-paclitaxel plus trastuzumab |
Trastuzumab | Herceptin | nab-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
Name | Type | Description | Interventions |
---|
nab-paclitaxel plus trastuzumab | Experimental | 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
- 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: | Terminated |
Lead Sponsor: | Osaka Medical College |
Last Updated
August 28, 2019