Clinical trial NCT01432223: Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
Official title: Phase II Study of Primary Chemotherapy With Anthracycline-based Regimen Followed by Nab-paclitaxel and Trastuzumab in Patients With HER2 Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
HER-2 Positive Breast Cancer
Effects of Chemotherapy
Keywords: Trastuzumab
Neoadjuvant chemotherapy
Primary chemotherapy
Lead sponsor: Osaka Medical College
Sponsor class: OTHER
First posted: 2011-09-12
Enrollment: 46
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 in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.

Detailed description: Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated.

Anthracycline-based regimen (d1, q3w):

EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)

Nab-paclitaxel 260mg/m2 (d1, q3w)

Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed invasive breast cancer
* T1c-3 N0-2a
* Confirmed of hormonal receptor status
* HER2 positive confirmed by IHC 3+ or FISH+
* LVEF \> 50% by echocardiogram or MUGA
* Adequate EKG
* No prior treatment for breast cancer
* PS 0-1
* 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
* Written informed consent

Exclusion Criteria:

* With history of hypersensitivity reaction for important drug in this study
* With history of invasive breast cancer
* Bilateral invasive breast cancer
* Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
* Positive for HBs antigen and with history of HVB
* With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
* With severe edema
* With severe peripheral neuropathy
* With severe psychiatric disorder
* Pregnant or nursing women
* Cases who physician judged improper to entry this trial

Primary outcomes:
measure: To evaluate the pathological complete response rate
timeFrame: 1 year from last patient enrolled
Secondary outcomes:
measure: Disease free survival
timeFrame: 5 years from the last patient enrolled
measure: Overall response rate
timeFrame: After the protocol therapy
measure: Pathological response rate
timeFrame: After the protocol therapy
measure: Breast-conserving surgery rate
timeFrame: After the protocol therapy
measure: Safety
timeFrame: Within the protocol thepapy
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, Iwamoto M, Kimura K, Matsunami N, Morishima H, Yoshidome K, Nomura T, Morimoto T, Yamamoto D, Tsubota Y, Kobayashi T, Uchiyama K. Phase II Study of Neoadjuvant Anthracycline-Based Regimens Combined With Nanoparticle Albumin-Bound Paclitaxel and Trastuzumab for Human Epidermal Growth Factor Receptor 2-Positive Operable Breast Cancer. Clin Breast Cancer. 2015 Jun;15(3):191-6. doi: 10.1016/j.clbc.2014.12.003. Epub 2014 Dec 24.