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Neoadjuvant Nab-PTX and Trastuzumab for ER Negative and HER2 Positive Breast Cancer

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ClinicalTrials.gov Identifier: NCT02598310
Recruitment Status : Recruiting
First Posted : November 5, 2015
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Satoru Tanaka, Osaka Medical College

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Estrogen Receptor Negative Neoplasm HER-2 Positive Breast Cancer Drug: nab-paclitaxel Drug: Trastuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant Nab-paclitaxel (PTX) and Trastuzumab for ER Negative and HER2 Positive Breast Cancer
Actual Study Start Date : November 2015
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 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.
Drug: nab-paclitaxel
nab-paclitaxel 260mg/m2 q3w
Other Name: Abraxane

Drug: Trastuzumab
trastuzumab 6 mg/kg (8 mg/kg as the loading dose)
Other Name: Herceptin




Primary Outcome Measures :
  1. Pathological complete response rate [ Time Frame: Up to 12 weeks after the protocol therapy ]

Secondary Outcome Measures :
  1. Disease free survival [ Time Frame: Five years after the last patient enrolled ]
  2. Objective response rate [ Time Frame: Up to 6 weeks after the protocol therapy ]
  3. Pathological response rate [ Time Frame: Up to 12 weeks after the protocol therapy ]
  4. Breast-conserving surgery rate [ Time Frame: Up to 6 weeks after the protocol therapy ]
  5. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Up to 6 weeks after the protocol therapy ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02598310


Contacts
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Contact: Satoru Tanaka, MD, PhD +81-72-683-1221 sur112@osaka-med.ac.jp
Contact: Kimura Kosei, MD, PhD +81-72-683-1221 sur121@osaka-med.ac.jp

Locations
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Japan
Osaka Medical College Recruiting
Takatsuki, Osaka, Japan, 5698686
Contact: Satoru Tanaka, MD, PhD       sur112@osaka-med.ac.jp   
Contact: Mitsuhiko Iwamoto, MD, PhD       sur067@osaka-med.ac.jp   
Sub-Investigator: Kosei Kimura, MD, PhD         
Sub-Investigator: Hiroya Fujioka, MD, PhD         
Sponsors and Collaborators
Osaka Medical College
Investigators
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Principal Investigator: Mitsuhiko Iwamoto, MD, PhD Osaka Medical College

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Responsible Party: Satoru Tanaka, MD, PhD, Osaka Medical College
ClinicalTrials.gov Identifier: NCT02598310     History of Changes
Other Study ID Numbers: OMC BC-04
OMC BC-04 ( Other Identifier: Osaka Medical College )
First Posted: November 5, 2015    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological