Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab
This study is currently recruiting participants.
Verified September 2011 by Osaka Medical College
Sponsor:
Osaka Medical College
Information provided by (Responsible Party):
Satoru Tanaka, Osaka Medical College
ClinicalTrials.gov Identifier:
NCT01432223
First received: September 8, 2011
Last updated: September 9, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer HER-2 Positive Breast Cancer Effects of Chemotherapy |
Drug: Nab-paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Osaka Medical College:
Primary Outcome Measures:
- To evaluate the pathological complete response rate [ Time Frame: 1 year from last patient enrolled ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the overall response rate [ Time Frame: 1 year from last patient enrolled ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 45 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | August 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Nab-paclitaxel |
Drug: Nab-paclitaxel
Nab-paclitaxel 260mg/m2 q3w
Other Name: Abraxane
|
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| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01432223
Contacts
| Contact: Satoru Tanaka, MD, PhD | sur112@poh.osaka-med.ac.jp | |
| Contact: Mitsuhiko Iwamoto, MD, PhD | sur067@poh.osaka-med.ac.jp |
Locations
| Japan | |
| Osaka Medical College | Recruiting |
| Takatsuki, Osaka, Japan, 5698686 | |
| Contact: Satoru Tanaka, MD, PhD sur112@poh.osaka-med.ac.jp | |
| Contact: Mitsuhiko Iwamoto, MD, PhD sur067@poh.osaka-med.ac.jp | |
Sponsors and Collaborators
Osaka Medical College
Investigators
| Principal Investigator: | Mitsuhiko Iwamoto, MD, PhD | Osaka Medical College |
More Information
No publications provided
| Responsible Party: | Satoru Tanaka, MD, PhD, Osaka Medical College |
| ClinicalTrials.gov Identifier: | NCT01432223 History of Changes |
| Other Study ID Numbers: | OMC-BC01, UMIN000006288 |
| Study First Received: | September 8, 2011 |
| Last Updated: | September 9, 2011 |
| Health Authority: | Japan: Institutional Review Board |
Keywords provided by Osaka Medical College:
|
Trastuzumab Neoadjuvant chemotherapy Primary chemotherapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Trastuzumab Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013