Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432223
• Other study ID #: OMC-BC01
• Secondary ID: UMIN000006288
• Status: Completed
• Phase: Phase 2
• First received: September 8, 2011
• Last updated: April 21, 2015
• Start date: September 2011
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: Osaka Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Effects of Chemotherapy
• HER-2 Positive Breast Cancer

Intervention

Drug:
• Nab-paclitaxel
Nab-paclitaxel 260mg/m2 q3w

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, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the pathological complete response rate		1 year from last patient enrolled	No
Secondary	Disease free survival		5 years from the last patient enrolled	No
Secondary	Overall response rate		After the protocol therapy	No
Secondary	Pathological response rate		After the protocol therapy	No
Secondary	Breast-conserving surgery rate		After the protocol therapy	No
Secondary	Safety		Within the protocol thepapy	Yes