Clinical trial NCT02598310: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Estrogen Receptor Negative Neoplasm
HER-2 Positive Breast Cancer
Lead sponsor: Osaka Medical College
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Pathological complete response rate
timeFrame: Up to 12 weeks after the protocol therapy
Secondary outcomes:
measure: Disease free survival
timeFrame: Five years after the last patient enrolled
measure: Objective response rate
timeFrame: Up to 6 weeks after the protocol therapy
measure: Pathological response rate
timeFrame: Up to 12 weeks after the protocol therapy
measure: Breast-conserving surgery rate
timeFrame: Up to 6 weeks after the protocol therapy
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: Up to 6 weeks after the protocol therapy
Other outcomes:
Locations:
city: Takatsuki
country: Japan
facility: Osaka Medical College
state: Osaka
Study officials:
affiliation: Osaka Medical College
name: Mitsuhiko Iwamoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.