Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer
- Conditions
- Stage II Breast CancerStage IIIA Breast CancerBreast CancerBreast NeoplasmsHER2-positive Breast Cancer
- Interventions
- Biological: Herceptin®Biological: TX05 (trastuzumab)
- Registration Number
- NCT03556358
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 809
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TX05 (trastuzumab) Paclitaxel • 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 TX05 (trastuzumab) Epirubicin • 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 Herceptin® 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 Herceptin® Epirubicin • 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 TX05 (trastuzumab) 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 TX05 (trastuzumab) Cyclophosphamide • 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 Herceptin® Cyclophosphamide • 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 Herceptin® Paclitaxel • 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
- Primary Outcome Measures
Name Time Method Proportion of Subjects in Each Treatment Arm Who Achieve Pathologic Complete Response (pCR) 3-7 weeks following last dose of study treatment 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).
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) End of Treatment (Week 24) or Early Termination Visit Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (ORR) = CR + PR.
Trial Locations
- Locations (146)
Tanvex Investigational Site 4002
🇨🇱Viña Del Mar, Chile
Tanvex Investigational Site 1007
🇧🇾Babruysk, Mogilev Region, Belarus
Tanvex Investigational Site 1008
🇧🇾Lesnoy, Minsk Region, Belarus
Tanvex Investigational Site 5007
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 1503
🇷🇺Omsk, Russian Federation
Tanvex Investigational Site 1517
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1821
🇺🇦Chernivtsi, Ukraine
Tanvex Investigational Site 1533
🇷🇺Tomsk, Russian Federation
Tanvex Investigational Site 1820
🇺🇦Kherson, Ukraine
Tanvex Investigational Site 1815
🇺🇦Kiev, Ukraine
Tanvex Investigational Site 1811
🇺🇦Kiev, Ukraine
Tanvex Investigational Site 1809
🇺🇦Kyiv, Ukraine
Tanvex Investigational Site 1808
🇺🇦Chernihiv, Ukraine
Tanvex Investigational Site 1803
🇺🇦Dnepropetrovsk, Ukraine
Tanvex Investigational Site 1501
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1508
🇷🇺Saransk, Russian Federation
Tanvex Investigational Site 1526
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 2103
🇲🇽Monterrey, Mexico
Tanvex Investigational Site 2112
🇲🇽San Luis Potosí, Mexico
Tanvex Investigational Site 1819
🇺🇦Kropyvnytskyi, Ukraine
Tanvex Investigational Site 1810
🇺🇦Odesa, Ukraine
Tanvex Investigational Site 1537
🇷🇺Orenburg, Russian Federation
Tanvex Investigational Site 1516
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1521
🇷🇺Rostov-Na-Donu, Russian Federation
Tanvex Investigational Site 1534
🇷🇺Yaroslavl, Russian Federation
Tanvex Investigational Site 1523
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1515
🇷🇺Izhevsk, Russian Federation
Tanvex Investigational Site 1812
🇺🇦Khmelnytskyi, Ukraine
Tanvex Investigational Site 7002
🇮🇳Bīkaner, Rajasthan, India
Tanvex Investigational Site 7010
🇮🇳Madurai, Tamil Nadu, India
Tanvex Investigational Site 7009
🇮🇳Jaipur, India
Tanvex Investigational Site 5006
🇬🇪Batumi, Georgia
Tanvex Investigational Site 7037
🇮🇳Bangalore, India
Tanvex Investigational Site 7015
🇮🇳Pune, Maharashtra, India
Tanvex Investigational Site 7003
🇮🇳Pune, Maharashtra, India
Tanvex Investigational Site 5005
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 7041
🇮🇳Model Town, India
Tanvex Investigational Site 7018
🇮🇳Vadodara, India
Tanvex Investigational Site 5008
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 1113
🇵🇪San Borja, Lima, Peru
Tanvex Investigational Site 1110
🇵🇪Lima, Peru
Tanvex Investigational Site 1208
🇵🇭Quezon City, Manila, Philippines
Tanvex Investigational Site 1209
🇵🇭Quezon City, Philippines
Tanvex Investigational Site 7040
🇮🇳Kolkata, India
Tanvex Investigational Site 2102
🇲🇽Monterrey, Nuevo León, Mexico
Tanvex Investigational Site 7031
🇮🇳Naka, India
Tanvex Investigational Site 2113
🇲🇽Mexico, Mexico
Tanvex Investigational Site 2108
🇲🇽Zapopan, Mexico
Tanvex Investigational Site 1108
🇵🇪San Borja, Lima, Peru
Tanvex Investigational Site 1101
🇵🇪Arequipa, Peru
Tanvex Investigational Site 1505
🇷🇺Kursk, Russian Federation
Tanvex Investigational Site 1530
🇷🇺Moscow, Russian Federation
Tanvex Investigational Site 1536
🇷🇺Moscow, Russian Federation
Tanvex Investigational Site 1525
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1506
🇷🇺Saint Petersburg, Russian Federation
Tanvex Investigational Site 1524
🇷🇺Saint-Petersburg, Russian Federation
Tanvex Investigational Site 6005
🇭🇺Debrecen, Hungary
Tanvex Investigational Site 1003
🇧🇾Gomel, Belarus
Tanvex Investigational Site 1006
🇧🇾Grodno, Belarus
Tanvex Investigational Site 1002
🇧🇾Minsk, Belarus
Tanvex Investigational Site 1005
🇧🇾Mogilev, Belarus
Tanvex Investigational Site 4001
🇨🇱Temuco, Chile
Tanvex Investigational Site 1001
🇧🇾Vitebsk, Belarus
Tanvex Investigational Site 5002
🇬🇪Batumi, Georgia
Tanvex Investigational Site 5003
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 5001
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 5012
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 5013
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 5004
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 5011
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 5009
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 5010
🇬🇪Tbilisi, Georgia
Tanvex Investigational Site 6007
🇭🇺Budapest, Hungary
Tanvex Investigational Site 6003
🇭🇺Budapest, Hungary
Tanvex Investigational Site 6004
🇭🇺Miskolc, Hungary
Tanvex Investigational Site 6006
🇭🇺Győr, Hungary
Tanvex Investigational Site 6001
🇭🇺Pécs, Hungary
Tanvex Investigational Site 7007
🇮🇳Nashik, Maharashtra, India
Tanvex Investigational Site 7004
🇮🇳Pune, Maharashtra, India
Tanvex Investigational Site 2117
🇲🇽Aguascalientes, Mexico
Tanvex Invesitgational Site 7033
🇮🇳Ahmedabad, India
Tanvex Investigational Site 7013
🇮🇳Coimbatore, India
Tanvex Investigational Site 7034
🇮🇳Chandigarh, India
Tanvex Investigational Site 7019
🇮🇳Bangalore, India
Tanvex Investigational Site 7022
🇮🇳Belgaum, India
Tanvex Investigational Site 7045
🇮🇳Hyderabad, India
Tanvex Investigational Site 7036
🇮🇳Hyderabad, India
Tanvex Investigational Site 7024
🇮🇳Gurgaon, India
Tanvex Investigational Site 7039
🇮🇳Kolkata, India
Tanvex Investigational Site 7006
🇮🇳Kolkata, India
Tanvex Investigational Site 7012
🇮🇳Manipala, India
Tanvex Investigational Site 7005
🇮🇳Lucknow, India
Tanvex Investigational Site 7042
🇮🇳Trichy, India
Tanvex Investigational Site 7001
🇮🇳Nashik, India
Tanvex Investigational Site 7017
🇮🇳Vijayawada, India
Tanvex Investigational Site 2109
🇲🇽Aguascalientes, Mexico
Tanvex Investigational Site 2116
🇲🇽Cancun, Mexico
Tanvex Investigational Site 2111
🇲🇽Ciudad de mexico, Mexico
Tanvex Investigational Site 2104
🇲🇽Cuauhtemoc, Mexico
Tanvex Investigational Site 2114
🇲🇽Cuauhtémoc, Mexico
Tanvex Investigational Site 2101
🇲🇽Cuautitlán Izcalli, Mexico
Tanvex Investigational Site 2106
🇲🇽Oaxaca, Mexico
Tanvex Investigational Site 2110
🇲🇽Tequisquiapan, Mexico
Tanvex Investigational Site 1107
🇵🇪Arequipa, Peru
Tanvex Investigational Site 1104
🇵🇪Chiclayo, Lambayeque, Peru
Tanvex Investigational Site 1112
🇵🇪Lima Cercado, Lima, Peru
Tanvex Investigational Site 1105
🇵🇪San Isidro, Peru
Tanvex Investigational Site 1102
🇵🇪San Isidro, Peru
Tanvex Investigational Site 1103
🇵🇪Trujillo, Peru
Tanvex Investigational Site 1109
🇵🇪Surquillo, Peru
Tanvex Investigational Site 1210
🇵🇭Santo Tomas, Batangas, Philippines
Tanvex Investigational Site 1211
🇵🇭Cebu City, Cebu, Philippines
Tanvex Investigational Site 1203
🇵🇭Cebu City, Cebu, Philippines
Tanvex Investigational Site 1204
🇵🇭Cebu City, Cebu, Philippines
Tanvex Investigational Site 1207
🇵🇭Manila, Metro Manila, Philippines
Tanvex Investigational Site 1206
🇵🇭Bacolod City, Negros Occidental, Philippines
Tanvex Investigational Site 1201
🇵🇭Manila, Philippines
Tanvex Investigational Site 1214
🇵🇭Makati City, Philippines
Tanvex Investigational Site 1212
🇵🇭Davao City, Philippines
Tanvex Investigational Site 1213
🇵🇭Quezon City, Philippines
Tanvex Investigational Site 1529
🇷🇺Krasnodar, Krasnodar Region, Russian Federation
Tanvex Investigational Site 1513
🇷🇺Sochi, Krasnodar Region, Russian Federation
Tanvex Investigational Site 1509
🇷🇺Omsk, Omsk Region, Russian Federation
Tanvex Investigational Site 1510
🇷🇺Pushkin, Saint Petersburg, Russian Federation
Tanvex Investigational Site 1511
🇷🇺Novosibirsk, Siberia, Russian Federation
Tanvex Investigational Site 1519
🇷🇺Pyatigorsk, Stavropol Region, Russian Federation
Tanvex Investigational Site 1518
🇷🇺Tomsk, Tomsk Region, Russian Federation
Tanvex Investigational Site 1535
🇷🇺Arkhangel'sk, Russian Federation
Tanvex Investigational Site 1531
🇷🇺Belgorod, Russian Federation
Tanvex Investigational Site 1538
🇷🇺Chelyabinsk, Russian Federation
Tanvex Investigational Site 1502
🇷🇺Kaluga, Russian Federation
Tanvex Investigational Site 1520
🇷🇺Ivanovo, Russian Federation
Tanvex Investigational Site 1512
🇷🇺Krasnoyarsk, Russian Federation
Tanvex Investigational Site 1540
🇷🇺Kazan, Russian Federation
Tanvex Investigational Site 1507
🇷🇺Moscow, Russian Federation
Tanvex Investigational Site 1514
🇷🇺Moscow, Russian Federation
Tanvex Investigational Site 1824
🇺🇦Dnipro, Ukraine
Tanvex Investigational Site 1814
🇺🇦Kirovogrado, Ukraine
Tanvex Investigational Site 1802
🇺🇦Kiev, Ukraine
Tanvex Investigational Site 1806
🇺🇦Sumy, Ukraine
Tanvex Investigational Site 1818
🇺🇦Vinnitsya, Ukraine
Tanvex Investigational Site 1822
🇺🇦Ternopil', Ukraine
Tanvex Investigational Site 1813
🇺🇦Zaporizhzhia, Ukraine
Tanvex Investigational Site 1823
🇺🇦Úzhgorod, Ukraine
Tanvex Investigational Site 1522
🇷🇺Ufa, Republic Of Bashkortostan, Russian Federation
Tanvex Investigational Site 1804
🇺🇦Kryvyi Rih, Ukraine