Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer
NCT ID: NCT02598310
Last Updated: 2019-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
30 participants
INTERVENTIONAL
2015-11-30
2018-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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nab-paclitaxel plus 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.
nab-paclitaxel
nab-paclitaxel 260mg/m2 q3w
Trastuzumab
trastuzumab 6 mg/kg (8 mg/kg as the loading dose)
Interventions
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nab-paclitaxel
nab-paclitaxel 260mg/m2 q3w
Trastuzumab
trastuzumab 6 mg/kg (8 mg/kg as the loading dose)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
20 Years
70 Years
FEMALE
No
Sponsors
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Osaka Medical College
OTHER
Responsible Party
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Satoru Tanaka
MD, PhD
Principal Investigators
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Mitsuhiko Iwamoto, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Osaka Medical College
Locations
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Osaka Medical College
Takatsuki, Osaka, Japan
Countries
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References
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Tanaka S, Matsunami N, Morishima H, Oda N, Takashima T, Noda S, Kashiwagi S, Tauchi Y, Asano Y, Kimura K, Fujioka H, Terasawa R, Kawaguchi K, Ikari A, Morimoto T, Michishita S, Kobayashi T, Sakane J, Nitta T, Sato N, Hokimoto N, Nishida Y, Iwamoto M. De-escalated neoadjuvant therapy with nanoparticle albumin-bound paclitaxel and trastuzumab for low-risk pure HER2 breast cancer. Cancer Chemother Pharmacol. 2019 Jun;83(6):1099-1104. doi: 10.1007/s00280-019-03836-z. Epub 2019 Apr 8.
Other Identifiers
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OMC BC-04
Identifier Type: OTHER
Identifier Source: secondary_id
OMC BC-04
Identifier Type: -
Identifier Source: org_study_id
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