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

NCT03556358 | Completed Phase 3 Results FDA Drug

• 1 other identifier: TX05-03
• Study Type: interventional
• Target: 809
• Locations: 10 countries
• Sites: 146

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.

Conditions

Breast Cancer; Breast Neoplasms; HER2-positive Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer

Keywords

trastuzumab; Herceptin

Outcome Measures

Primary Outcomes (1)

• Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR)

  Pathologic complete response was determined by central review and defined as 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).

  3-7 weeks following last dose of study treatment

Secondary Outcomes (1)

• Objective Response Rate (ORR)

  End of Treatment (Week 24) or Early Termination Visit

Study Arms (2)

TX05 (trastuzumab)

EXPERIMENTAL

• 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); Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide

Herceptin®

ACTIVE COMPARATOR

• 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®; Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide

Interventions

TX05 (trastuzumab) BIOLOGICAL

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

TX05 (trastuzumab)

Herceptin® BIOLOGICAL

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

Herceptin®

Paclitaxel DRUG

175 mg/m\^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)

Also known as: Ribotax

Herceptin®; TX05 (trastuzumab)

Epirubicin DRUG

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

Herceptin®; TX05 (trastuzumab)

Cyclophosphamide DRUG

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

Herceptin®; TX05 (trastuzumab)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanvex BioPharma USA, Inc.: lead

Study Sites (146)

Tanvex Investigational Site 1008

Lyasny, Minsk Oblast, 223040, Belarus

Location

Tanvex Investigational Site 1007

Babruysk, Mogilyov Oblast, 213825, Belarus

Location

Tanvex Investigational Site 1006

Grodno, 230017, Belarus

Location

Tanvex Investigational Site 1003

Homyel, 246012, Belarus

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Tanvex Investigational Site 1002

Minsk, 220013, Belarus

Location

Tanvex Investigational Site 1005

Mogilev, 2120018, Belarus

Location

Tanvex Investigational Site 1001

Vitebsk, 21008, Belarus

Location

Tanvex Investigational Site 4001

Temuco, 4810469, Chile

Location

Tanvex Investigational Site 4002

Viña del Mar, 2520598, Chile

Location

Tanvex Investigational Site 5006

Batumi, 6000, Georgia

Location

Tanvex Investigational Site 5002

Batumi, 6010, Georgia

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Tanvex Investigational Site 5003

Tbilisi, 0144, Georgia

Location

Tanvex Investigational Site 5001

Tbilisi, 0159, Georgia

Location

Tanvex Investigational Site 5005

Tbilisi, 0159, Georgia

Location

Tanvex Investigational Site 5012

Tbilisi, 0159, Georgia

Location

Tanvex Investigational Site 5013

Tbilisi, 0177, Georgia

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Tanvex Investigational Site 5004

Tbilisi, 0179, Georgia

Location

Tanvex Investigational Site 5010

Tbilisi, 0186, Georgia

Location

Tanvex Investigational Site 5011

Tbilisi, 0186, Georgia

Location

Tanvex Investigational Site 5008

Tbilisi, 112, Georgia

Location

Tanvex Investigational Site 5009

Tbilisi, 131, Georgia

Location

Tanvex Investigational Site 5007

Tbilisi, 141, Georgia

Location

Tanvex Investigational Site 6003

Budapest, 1122, Hungary

Location

Tanvex Investigational Site 6007

Budapest, 1122, Hungary

Location

Tanvex Investigational Site 6005

Debrecen, 4032, Hungary

Location

Tanvex Investigational Site 6006

Győr, 9024, Hungary

Location

Tanvex Investigational Site 6004

Miskolc, 3526, Hungary

Location

Tanvex Investigational Site 6001

Pécs, 7264, Hungary

Location

Tanvex Investigational Site 7007

Nashik, Maharashtra, 422005, India

Location

Tanvex Investigational Site 7015

Pune, Maharashtra, 411001, India

Location

Tanvex Investigational Site 7003

Pune, Maharashtra, 411004, India

Location

Tanvex Investigational Site 7004

Pune, Maharashtra, 411004, India

Location

Tanvex Investigational Site 7002

Bikaner, Rajasthan, 334003, India

Location

Tanvex Investigational Site 7010

Madurai, Tamil Nadu, 625107, India

Location

Tanvex Invesitgational Site 7033

Ahmedabad, 380016, India

Location

Tanvex Investigational Site 7019

Bangalore, 560027, India

Location

Tanvex Investigational Site 7037

Bangalore, 560072, India

Location

Tanvex Investigational Site 7022

Belagavi, 590010, India

Location

Tanvex Investigational Site 7034

Chandigarh, 160012, India

Location

Tanvex Investigational Site 7013

Coimbatore, 641037, India

Location

Tanvex Investigational Site 7024

Gūrgaon, 122001, India

Location

Tanvex Investigational Site 7045

Hyderabad, 500004, India

Location

Tanvex Investigational Site 7036

Hyderabad, 500034, India

Location

Tanvex Investigational Site 7009

Jaipur, 302004, India

Location

Tanvex Investigational Site 7039

Kolkata, 700014, India

Location

Tanvex Investigational Site 7040

Kolkata, 700094, India

Location

Tanvex Investigational Site 7006

Kolkata, 700099, India

Location

Tanvex Investigational Site 7005

Lucknow, 226003, India

Location

Tanvex Investigational Site 7012

Manipal, 576104, India

Location

Tanvex Investigational Site 7041

Model Town, 141002, India

Location

Tanvex Investigational Site 7001

Nashik, 422002, India

Location

Tanvex Investigational Site 7031

Nāka, 422004, India

Location

Tanvex Investigational Site 7042

Trichy, 620008, India

Location

Tanvex Investigational Site 7018

Vadodara, 390007, India

Location

Tanvex Investigational Site 7017

Vijayawada, 520002, India

Location

Tanvex Investigational Site 2102

Monterrey, Nuevo León, 64000, Mexico

Location

Tanvex Investigational Site 2117

Aguascalientes, 20127, Mexico

Location

Tanvex Investigational Site 2109

Aguascalientes, 20234, Mexico

Location

Tanvex Investigational Site 2116

Cancún, 77506, Mexico

Location

Tanvex Investigational Site 2104

Cuauhtémoc, 06100, Mexico

Location

Tanvex Investigational Site 2114

Cuauhtémoc, 06760, Mexico

Location

Tanvex Investigational Site 2101

Cuautitlán Izcalli, 54769, Mexico

Location

Tanvex Investigational Site 2111

Mexico City, 06760, Mexico

Location

Tanvex Investigational Site 2113

México, 06100, Mexico

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Tanvex Investigational Site 2103

Monterrey, 64320, Mexico

Location

Tanvex Investigational Site 2106

Oaxaca City, 68000, Mexico

Location

Tanvex Investigational Site 2112

San Luis Potosí City, 78200, Mexico

Location

Tanvex Investigational Site 2110

Tequisquiapan, 76750, Mexico

Location

Tanvex Investigational Site 2108

Zapopan, 45030, Mexico

Location

Tanvex Investigational Site 1104

Chiclayo, Lambayeque, 14001, Peru

Location

Tanvex Investigational Site 1112

Lima Cercado, Lima region, 15082, Peru

Location

Tanvex Investigational Site 1108

San Borja, Lima region, 15036, Peru

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Tanvex Investigational Site 1113

San Borja, Lima region, 15036, Peru

Location

Tanvex Investigational Site 1101

Arequipa, 04001, Peru

Location

Tanvex Investigational Site 1107

Arequipa, 04001, Peru

Location

Tanvex Investigational Site 1110

Lima, 15046, Peru

Location

Tanvex Investigational Site 1105

San Isidro, 15036, Peru

Location

Tanvex Investigational Site 1102

San Isidro, 15073, Peru

Location

Tanvex Investigational Site 1109

Surquillo, 15038, Peru

Location

Tanvex Investigational Site 1103

Trujillo, 13001, Peru

Location

Tanvex Investigational Site 1210

Santo Tomas, Batangas, 4234, Philippines

Location

Tanvex Investigational Site 1203

Cebu City, Cebu, 6000, Philippines

Location

Tanvex Investigational Site 1204

Cebu City, Cebu, 6000, Philippines

Location

Tanvex Investigational Site 1211

Cebu City, Cebu, 6000, Philippines

Location

Tanvex Investigational Site 1208

Quezon City, Manila, 1110, Philippines

Location

Tanvex Investigational Site 1207

Manila, National Capital Region, 1000, Philippines

Location

Tanvex Investigational Site 1206

Bacolod City, Negros Occidental, 6100, Philippines

Location

Tanvex Investigational Site 1212

Davao City, 8000, Philippines

Location

Tanvex Investigational Site 1214

Makati City, 1229, Philippines

Location

Tanvex Investigational Site 1201

Manila, 1000, Philippines

Location

Tanvex Investigational Site 1209

Quezon City, 1101, Philippines

Location

Tanvex Investigational Site 1213

Quezon City, 1102, Philippines

Location

Tanvex Investigational Site 1522

Ufa, Bashkortostan Republic, 450054, Russia

Location

Tanvex Investigational Site 1529

Krasnodar, Krasnodarskiy Kray, 350040, Russia

Location

Tanvex Investigational Site 1513

Sochi, Krasnodarskiy Kray, 354057, Russia

Location

Tanvex Investigational Site 1509

Omsk, Omsk Oblast, 644013, Russia

Location

Tanvex Investigational Site 1510

Pushkin, Sankt-Peterburg, 196603, Russia

Location

Tanvex Investigational Site 1511

Novosibirsk, Siberia, 630099, Russia

Location

Tanvex Investigational Site 1519

Pyatigorsk, Stavropol Kray, 357502, Russia

Location

Tanvex Investigational Site 1518

Tomsk, Tomsk Oblast, 634050, Russia

Location

Tanvex Investigational Site 1535

Arkhangelsk, 163045, Russia

Location

Tanvex Investigational Site 1531

Belgorod, 308010, Russia

Location

Tanvex Investigational Site 1538

Chelyabinsk, 454048, Russia

Location

Tanvex Investigational Site 1520

Ivanovo, 153040, Russia

Location

Tanvex Investigational Site 1515

Izhevsk, 426009, Russia

Location

Tanvex Investigational Site 1502

Kaluga, 248007, Russia

Location

Tanvex Investigational Site 1540

Kazan', 420029, Russia

Location

Tanvex Investigational Site 1512

Krasnoyarsk, 660133, Russia

Location

Tanvex Investigational Site 1505

Kursk, 305035, Russia

Location

Tanvex Investigational Site 1530

Moscow, 121467, Russia

Location

Tanvex Investigational Site 1536

Moscow, 125284, Russia

Location

Tanvex Investigational Site 1514

Moscow, 129128, Russia

Location

Tanvex Investigational Site 1507

Moscow, 129515, Russia

Location

Tanvex Investigational Site 1503

Omsk, 644013, Russia

Location

Tanvex Investigational Site 1537

Orenburg, 460021, Russia

Location

Tanvex Investigational Site 1521

Rostov-on-Don, 344037, Russia

Location

Tanvex Investigational Site 1516

Saint Petersburg, 191015, Russia

Location

Tanvex Investigational Site 1517

Saint Petersburg, 191025, Russia

Location

Tanvex Investigational Site 1523

Saint Petersburg, 191104, Russia

Location

Tanvex Investigational Site 1524

Saint Petersburg, 195271, Russia

Location

Tanvex Investigational Site 1525

Saint Petersburg, 196247, Russia

Location

Tanvex Investigational Site 1506

Saint Petersburg, 197758, Russia

Location

Tanvex Investigational Site 1526

Saint Petersburg, 197758, Russia

Location

Tanvex Investigational Site 1501

Saint Petersburg, 198255, Russia

Location

Tanvex Investigational Site 1508

Saransk, 430032, Russia

Location

Tanvex Investigational Site 1533

Tomsk, 634009, Russia

Location

Tanvex Investigational Site 1534

Yaroslavl, 150054, Russia

Location

Tanvex Investigational Site 1808

Chernihiv, 14029, Ukraine

Location

Tanvex Investigational Site 1821

Chernivtsi, 58013, Ukraine

Location

Tanvex Investigational Site 1803

Dnipro, 49102, Ukraine

Location

Tanvex Investigational Site 1824

Dnipro, 49600, Ukraine

Location

Tanvex Investigational Site 1820

Kherson, 73000, Ukraine

Location

Tanvex Investigational Site 1812

Khmelnytskyi, 29000, Ukraine

Location

Tanvex Investigational Site 1815

Kiev, 03022, Ukraine

Location

Tanvex Investigational Site 1811

Kiev, 03115, Ukraine

Location

Tanvex Investigational Site 1802

Kiev, 04107, Ukraine

Location

Tanvex Investigational Site 1814

Kropyvnytskyi, 25000, Ukraine

Location

Tanvex Investigational Site 1819

Kropyvnytskyi, 25006, Ukraine

Location

Tanvex Investigational Site 1804

Kryvyi Rih, 50048, Ukraine

Location

Tanvex Investigational Site 1809

Kyiv, 03126, Ukraine

Location

Tanvex Investigational Site 1810

Odesa, 65055, Ukraine

Location

Tanvex Investigational Site 1806

Sumy, 40022, Ukraine

Location

Tanvex Investigational Site 1822

Ternopil, 46023, Ukraine

Location

Tanvex Investigational Site 1823

Uzhhorod, 88000, Ukraine

Location

Tanvex Investigational Site 1818

Vinnitsya, 21029, Ukraine

Location

Tanvex Investigational Site 1813

Zaporizhzhia, 69104, Ukraine

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Paclitaxel; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Study Director
• Organization: Tanvex

jennifer.lai@tanvex.com

19494838507

Study Officials

• Bonnie Mills, PhD

  Tanvex BioPharma USA, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2018
• First Posted: June 14, 2018
• Study Start: June 28, 2018
• Primary Completion: November 27, 2020
• Study Completion: February 4, 2021
• Last Updated: January 14, 2022
• Results First Posted: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (7); PH (12); RU (35); GE (13); HU (6); UA (19); PE (11); IN (27); ME (14); CL (2)