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Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT03556358
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Tanvex BioPharma USA, Inc.

Brief Summary:
This is a Phase III, double-blind, randomized, multicenter study to compare the efficacy and to evaluate the safety and immunogenicity of TX05 (trastuzumab) with Herceptin® in subjects with HER2 positive early breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Breast Neoplasms HER2-positive Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Biological: TX05 (trastuzumab) Biological: Herceptin® Drug: Paclitaxel Drug: Epirubicin Drug: Cyclophosphamide Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel Group, Phase III Trial to Compare the Efficacy, Safety, and Immunogenicity of TX05 With Herceptin® in Subjects With HER2 Positive Early Breast Cancer
Actual Study Start Date : June 28, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: TX05 (trastuzumab)

• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles

Followed by:

• IV TX05 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles

Biological: TX05 (trastuzumab)
8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)

Drug: Paclitaxel
175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)
Other Name: Ribotax

Drug: Epirubicin
75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)

Drug: Cyclophosphamide
600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)

Active Comparator: Herceptin®

• Intravenous (IV) epirubicin, 75 mg/m^2 and cyclophosphamide 600 mg/m2 every 3 weeks for 4 cycles

Followed by:

• IV Herceptin 8 mg/kg loading dose then 6 mg/kg and paclitaxel 175 mg/m2 every 3 weeks for 4 cycles

Biological: Herceptin®
8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)

Drug: Paclitaxel
175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)
Other Name: Ribotax

Drug: Epirubicin
75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)

Drug: Cyclophosphamide
600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)




Primary Outcome Measures :
  1. Pathologic complete response (pCR) [ Time Frame: 3-7 weeks following last dose of study treatment ]
    The absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled lymph nodes following neoadjuvant systemic therapy (ypT0/Tis ypN0)


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: End of Treatment (Week 24) or Early Termination Visit ]
    The sum of partial responses plus complete responses as measured per RECIST 1.1



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Histologically confirmed HER 2 overexpressing invasive primary operable Stage II/IIIa breast cancer (AJCC version 7 staging criteria).
  • Available tumor tissue for central review of HER2 status.
  • Planned surgical resection of breast tumor.
  • Planned neoadjuvant chemotherapy.
  • Documentation of HER2 gene amplification or overexpression.
  • Ipsilateral, measurable tumor longest diameter > 2 cm.
  • Known estrogen receptor (ER) and progesterone receptor (PR) hormone status (may be performed during screening).
  • ECOG performance status of 0 or 1.
  • Adequate bone marrow, hepatic and renal functions.
  • Left ventricular ejection fraction (LVEF) ≥ 50% or within institutional normal limits, measured by echocardiography or MUGA scan.
  • Effective contraception as defined by protocol.

Key Exclusion Criteria:

  • Investigational therapy within 2 months of first dose of study drug.
  • Bilateral breast cancer.
  • Inflammatory breast cancer
  • Metastases.
  • Prior chemotherapy, biologic therapy, radiation or surgery for any active malignancy, including breast cancer.
  • Cardiac insufficiency, myocardial infarction, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident, unstable angina pectoris, uncontrolled arrhythmia or pulmonary embolus within the previous 12 months prior to 1st administration of study drug.
  • Clinically significant active infection, poorly controlled diabetes mellitus and/or uncontrolled hypertension.
  • Major surgery, significant traumatic injury, radiation therapy and/or grade 3 hemorrhage within 4 weeks of 1st administration of study drug.
  • Pre-existing clinically significant Grade 2 peripheral neuropathy.
  • Malignancy within the last 5 years (except squamous/basal cell carcinoma of the skin, cervical carcinoma in situ and superficial bladder cancer).
  • Severe dyspnea at rest requiring oxygen therapy.
  • Known positive HIV, acute or chronic active infection with Hepatitis B or Hepatitis C.
  • Current pregnancy or breastfeeding.
  • Pre-existing thyroid abnormality with thyroid function that cannot be maintained in normal range despite optimal therapy.

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): NCT03556358


Contacts
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Contact: Jennifer Lai, MBA 949-483-8507 jennifer.lai@tanvex.com

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Locations
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Belarus
Tanvex Investigational Site Recruiting
Lesnoy, Minsk Region, Belarus, 223040
Tanvex Investigational Site Recruiting
Babruysk, Mogilev Region, Belarus, 213825
Tanvex Investigational Site Recruiting
Gomel, Belarus, 246012
Tanvex Investigational Site Recruiting
Grodno, Belarus, 230017
Tanvex Investigational Site Recruiting
Minsk, Belarus, 220013
Tanvex Investigational Site Recruiting
Mogilev, Belarus, 2120018
Tanvex Investigational Site Recruiting
Vitebsk, Belarus, 21008
Chile
Tanvex Investigational Site Recruiting
Temuco, Chile, 4810469
Tanvex Investigational Site Recruiting
Viña Del Mar, Chile, 2520598
Georgia
Tanvex Investigational Site Recruiting
Batumi, Georgia, 6000
Tanvex Investigational Site Recruiting
Batumi, Georgia, 6010
Tanvex Investigational Site Recruiting
Tbilisi, Georgia, 0144
Tanvex Investigational Site Recruiting
Tbilisi, Georgia, 0159
Tanvex Investigational Site Recruiting
Tbilisi, Georgia, 0177
Tanvex Investigational Site Recruiting
Tbilisi, Georgia, 0179
Tanvex Investigational Site Recruiting
Tbilisi, Georgia, 0186
Tanvex Investigational Site Recruiting
Tbilisi, Georgia, 112
Tanvex Investigational Site Recruiting
Tbilisi, Georgia, 131
Tanvex Investigational Site Recruiting
Tbilisi, Georgia, 141
Hungary
Tanvex Investigational Site Recruiting
Budapest, Hungary, 1122
Tanvex Investigational Site Recruiting
Debrecen, Hungary, 4032
Tanvex Investigational Site Recruiting
Győr, Hungary, 9024
Tanvex Investigational Site Recruiting
Miskolc, Hungary, 3526
Tanvex Investigational Site Active, not recruiting
Pécs, Hungary, 7264
India
Tanvex Investigational Site Recruiting
Nashik, Maharashtra, India, 422002
Tanvex Investigational Site Recruiting
Nashik, Maharashtra, India, 422005
Tanvex Investigational Site Recruiting
Pune, Maharashtra, India, 411001
Tanvex Investigational Site Recruiting
Pune, Maharashtra, India, 411004
Tanvex Investigational Site Recruiting
Pune, Maharashtra, India, 411057
Tanvex Investigational Site Recruiting
Bīkaner, Rajasthan, India, 334003
Tanvex Investigational Site Recruiting
Madurai, Tamil Nadu, India, 625107
Mexico
Tanvex Investigational Site Recruiting
Zapopan, Jalisco, Mexico, 45030
Tanvex Investigational Site Recruiting
Ciudad de Mexico, Mexico, 06100
Peru
Tanvex Investigational Site Recruiting
Trujillo, La Libertad, Peru, 13001
Tanvex Investigational Site Recruiting
Chiclayo, Lambayeque, Peru, 14001
Tanvex Investigational Site Recruiting
San Borja, Lima, Peru, 15036
Tanvex Investigational Site Recruiting
Arequipa, Peru, 04001
Tanvex Investigational Site Recruiting
Lima, Peru, 15038
Tanvex Investigational Site Recruiting
Lima, Peru, 15046
Tanvex Investigational Site Recruiting
Lima, Peru, 15073
Tanvex Investigational Site Recruiting
Lima, Peru, 15082
Philippines
Tanvex Investigational Site Recruiting
Santo Tomas, Batangas, Philippines, 4234
Tanvex Investigational Site Recruiting
Cebu City, Cebu, Philippines, 6000
Tanvex Investigational Site Recruiting
Quezon City, Manila, Philippines, 1110
Tanvex Investigational Site Recruiting
Manila, Metro Manila, Philippines, 1000
Tanvex Investigational Site Recruiting
Makati City, National Capital Reg, Philippines, 1229
Tanvex Investigational Site Recruiting
Quezon City, National Capital Reg, Philippines, 1101
Tanvex Investigational Site Recruiting
Quezon City, NCR, Philippines, 1102
Tanvex Investigational Site Recruiting
Bacolod City, Negros Occidental, Philippines, 6100
Tanvex Investigational Site Recruiting
Davao City, Philippines, 8000
Tanvex Investigational Site Recruiting
Manila, Philippines, 1000
Poland
Tanvex Investigational Site Recruiting
Łódź, Poland, 91-211
Russian Federation
Tanvex Investigational Site Recruiting
Krasnodar, Krasnodar Region, Russian Federation, 350040
Tanvex Investigational Site Recruiting
Sochi, Krasnodar Region, Russian Federation, 354057
Tanvex Investigational Site Recruiting
Omsk, Omsk Region, Russian Federation, 644013
Tanvex Investigational Site Recruiting
Ufa, Republic Of Bashkortostan, Russian Federation, 450054
Tanvex Investigational Site Recruiting
Pushkin, Saint Petersburg, Russian Federation, 196603
Tanvex Investigational Site Recruiting
Novosibirsk, Siberia, Russian Federation, 630099
Tanvex Investigational Site Recruiting
Pyatigorsk, Stavropol Region, Russian Federation, 357502
Tanvex Investigational Site Recruiting
Tomsk, Tomsk Region, Russian Federation, 634050
Tanvex Investigational Site Recruiting
Arkhangel'sk, Russian Federation, 163045
Tanvex Investigational Site Recruiting
Belgorod, Russian Federation, 308010
Tanvex Investigational Site Recruiting
Ivanovo, Russian Federation, 153040
Tanvex Investigational Site Recruiting
Izhevsk, Russian Federation, 426009
Tanvex Investigational Site Recruiting
Kaluga, Russian Federation, 248007
Tanvex Investigational Site Recruiting
Krasnoyarsk, Russian Federation, 660133
Tanvex Investigational Site Recruiting
Kursk, Russian Federation, 305035
Tanvex Investigational Site Recruiting
Moscow, Russian Federation, 121467
Tanvex Investigational Site Recruiting
Moscow, Russian Federation, 125284
Tanvex Investigational Site Recruiting
Moscow, Russian Federation, 129515
Tanvex Investigational Site Recruiting
Omsk, Russian Federation, 644013
Tanvex Investigational Site Recruiting
Rostov-Na-Donu, Russian Federation, 344037
Tanvex Investigational Site Recruiting
Saint Petersburg, Russian Federation, 191015
Tanvex Investigational Site Recruiting
Saint Petersburg, Russian Federation, 191025
Tanvex Investigational Site Recruiting
Saint Petersburg, Russian Federation, 196247
Tanvex Investigational Site Recruiting
Saint Petersburg, Russian Federation, 197758
Tanvex Investigational Site Recruiting
Saint Petersburg, Russian Federation, 198255
Tanvex Investigational Site Recruiting
Saint-Petersburg, Russian Federation, 195271
Tanvex Investigational Site Recruiting
Saransk, Russian Federation, 430032
Tanvex Investigational Site Recruiting
St. Petersburg, Russian Federation, 197758
Tanvex Investigational Site Recruiting
Tomsk, Russian Federation, 634009
Tanvex Investigational Site Recruiting
Yaroslavl, Russian Federation, 150054
Ukraine
Tanvex Investigational Site Recruiting
Chernihiv, Ukraine, 14029
Tanvex Investigational Site Recruiting
Dnipro, Ukraine, 49102
Tanvex Investigational Site Recruiting
Kherson, Ukraine, 73000
Tanvex Investigational Site Recruiting
Kiev, Ukraine, 03115
Tanvex Investigational Site Recruiting
Kiev, Ukraine, 04107
Tanvex Investigational Site Recruiting
Kryvyi Rih, Ukraine, 50048
Tanvex Investigational Site Recruiting
Odesa, Ukraine, 65055
Tanvex Investigational Site Recruiting
Sumy, Ukraine, 40022
Tanvex Investigational Site Recruiting
Vinnitsya, Ukraine, 21029
Tanvex Investigational Site Recruiting
Zaporizhzhia, Ukraine, 69104
Sponsors and Collaborators
Tanvex BioPharma USA, Inc.
Investigators
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Study Director: Bonnie Mills, PhD Tanvex BioPharma USA, Inc.

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Responsible Party: Tanvex BioPharma USA, Inc.
ClinicalTrials.gov Identifier: NCT03556358     History of Changes
Other Study ID Numbers: TX05-03
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tanvex BioPharma USA, Inc.:
trastuzumab
Herceptin

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Trastuzumab
Epirubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors