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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556358
• Other study ID #: TX05-03
• Status: Completed
• Phase: Phase 3
• Start date: June 28, 2018
• Est. completion date: February 4, 2021

Study information

• Verified date: January 2022
• Source: Tanvex BioPharma USA, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 809
• Est. completion date: February 4, 2021
• Est. primary completion date: November 27, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Biological:
• TX05 (trastuzumab)
8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
• 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)
• Epirubicin
75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)
• Cyclophosphamide
600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)

Locations

Country	Name	City	State
Belarus	Tanvex Investigational Site 1007	Babruysk	Mogilev Region
Belarus	Tanvex Investigational Site 1003	Gomel
Belarus	Tanvex Investigational Site 1006	Grodno
Belarus	Tanvex Investigational Site 1008	Lesnoy	Minsk Region
Belarus	Tanvex Investigational Site 1002	Minsk
Belarus	Tanvex Investigational Site 1005	Mogilev
Belarus	Tanvex Investigational Site 1001	Vitebsk
Chile	Tanvex Investigational Site 4001	Temuco
Chile	Tanvex Investigational Site 4002	Viña Del Mar
Georgia	Tanvex Investigational Site 5002	Batumi
Georgia	Tanvex Investigational Site 5006	Batumi
Georgia	Tanvex Investigational Site 5001	Tbilisi
Georgia	Tanvex Investigational Site 5003	Tbilisi
Georgia	Tanvex Investigational Site 5004	Tbilisi
Georgia	Tanvex Investigational Site 5005	Tbilisi
Georgia	Tanvex Investigational Site 5007	Tbilisi
Georgia	Tanvex Investigational Site 5008	Tbilisi
Georgia	Tanvex Investigational Site 5009	Tbilisi
Georgia	Tanvex Investigational Site 5010	Tbilisi
Georgia	Tanvex Investigational Site 5011	Tbilisi
Georgia	Tanvex Investigational Site 5012	Tbilisi
Georgia	Tanvex Investigational Site 5013	Tbilisi
Hungary	Tanvex Investigational Site 6003	Budapest
Hungary	Tanvex Investigational Site 6007	Budapest
Hungary	Tanvex Investigational Site 6005	Debrecen
Hungary	Tanvex Investigational Site 6006	Gyor
Hungary	Tanvex Investigational Site 6004	Miskolc
Hungary	Tanvex Investigational Site 6001	Pécs
India	Tanvex Invesitgational Site 7033	Ahmedabad
India	Tanvex Investigational Site 7019	Bangalore
India	Tanvex Investigational Site 7037	Bangalore
India	Tanvex Investigational Site 7022	Belgaum
India	Tanvex Investigational Site 7002	Bikaner	Rajasthan
India	Tanvex Investigational Site 7034	Chandigarh
India	Tanvex Investigational Site 7013	Coimbatore
India	Tanvex Investigational Site 7024	Gurgaon
India	Tanvex Investigational Site 7036	Hyderabad
India	Tanvex Investigational Site 7045	Hyderabad
India	Tanvex Investigational Site 7009	Jaipur
India	Tanvex Investigational Site 7006	Kolkata
India	Tanvex Investigational Site 7039	Kolkata
India	Tanvex Investigational Site 7040	Kolkata
India	Tanvex Investigational Site 7005	Lucknow
India	Tanvex Investigational Site 7010	Madurai	Tamil Nadu
India	Tanvex Investigational Site 7012	Manipala
India	Tanvex Investigational Site 7041	Model Town
India	Tanvex Investigational Site 7031	Naka
India	Tanvex Investigational Site 7001	Nashik
India	Tanvex Investigational Site 7007	Nashik	Maharashtra
India	Tanvex Investigational Site 7003	Pune	Maharashtra
India	Tanvex Investigational Site 7004	Pune	Maharashtra
India	Tanvex Investigational Site 7015	Pune	Maharashtra
India	Tanvex Investigational Site 7042	Trichy
India	Tanvex Investigational Site 7018	Vadodara
India	Tanvex Investigational Site 7017	Vijayawada
Mexico	Tanvex Investigational Site 2109	Aguascalientes
Mexico	Tanvex Investigational Site 2117	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 2113	Mexico
Mexico	Tanvex Investigational Site 2102	Monterrey	Nuevo León
Mexico	Tanvex Investigational Site 2103	Monterrey
Mexico	Tanvex Investigational Site 2106	Oaxaca
Mexico	Tanvex Investigational Site 2112	San Luis Potosí
Mexico	Tanvex Investigational Site 2110	Tequisquiapan
Mexico	Tanvex Investigational Site 2108	Zapopan
Peru	Tanvex Investigational Site 1101	Arequipa
Peru	Tanvex Investigational Site 1107	Arequipa
Peru	Tanvex Investigational Site 1104	Chiclayo	Lambayeque
Peru	Tanvex Investigational Site 1110	Lima
Peru	Tanvex Investigational Site 1112	Lima Cercado	Lima
Peru	Tanvex Investigational Site 1108	San Borja	Lima
Peru	Tanvex Investigational Site 1113	San Borja	Lima
Peru	Tanvex Investigational Site 1102	San Isidro
Peru	Tanvex Investigational Site 1105	San Isidro
Peru	Tanvex Investigational Site 1109	Surquillo
Peru	Tanvex Investigational Site 1103	Trujillo
Philippines	Tanvex Investigational Site 1206	Bacolod City	Negros Occidental
Philippines	Tanvex Investigational Site 1203	Cebu City	Cebu
Philippines	Tanvex Investigational Site 1204	Cebu City	Cebu
Philippines	Tanvex Investigational Site 1211	Cebu City	Cebu
Philippines	Tanvex Investigational Site 1212	Davao City
Philippines	Tanvex Investigational Site 1214	Makati City
Philippines	Tanvex Investigational Site 1201	Manila
Philippines	Tanvex Investigational Site 1207	Manila	Metro Manila
Philippines	Tanvex Investigational Site 1208	Quezon City	Manila
Philippines	Tanvex Investigational Site 1209	Quezon City
Philippines	Tanvex Investigational Site 1213	Quezon City
Philippines	Tanvex Investigational Site 1210	Santo Tomas	Batangas
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 1520	Ivanovo
Russian Federation	Tanvex Investigational Site 1515	Izhevsk
Russian Federation	Tanvex Investigational Site 1502	Kaluga
Russian Federation	Tanvex Investigational Site 1540	Kazan
Russian Federation	Tanvex Investigational Site 1529	Krasnodar	Krasnodar Region
Russian Federation	Tanvex Investigational Site 1512	Krasnoyarsk
Russian Federation	Tanvex Investigational Site 1505	Kursk
Russian Federation	Tanvex Investigational Site 1507	Moscow
Russian Federation	Tanvex Investigational Site 1514	Moscow
Russian Federation	Tanvex Investigational Site 1530	Moscow
Russian Federation	Tanvex Investigational Site 1536	Moscow
Russian Federation	Tanvex Investigational Site 1511	Novosibirsk	Siberia
Russian Federation	Tanvex Investigational Site 1503	Omsk
Russian Federation	Tanvex Investigational Site 1509	Omsk	Omsk Region
Russian Federation	Tanvex Investigational Site 1537	Orenburg
Russian Federation	Tanvex Investigational Site 1510	Pushkin	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1519	Pyatigorsk	Stavropol Region
Russian Federation	Tanvex Investigational Site 1521	Rostov-Na-Donu
Russian Federation	Tanvex Investigational Site 1501	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1506	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1516	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1517	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1523	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1525	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1526	Saint Petersburg
Russian Federation	Tanvex Investigational Site 1524	Saint-Petersburg
Russian Federation	Tanvex Investigational Site 1508	Saransk
Russian Federation	Tanvex Investigational Site 1513	Sochi	Krasnodar Region
Russian Federation	Tanvex Investigational Site 1518	Tomsk	Tomsk Region
Russian Federation	Tanvex Investigational Site 1533	Tomsk
Russian Federation	Tanvex Investigational Site 1522	Ufa	Republic Of Bashkortostan
Russian Federation	Tanvex Investigational Site 1534	Yaroslavl
Ukraine	Tanvex Investigational Site 1808	Chernihiv
Ukraine	Tanvex Investigational Site 1821	Chernivtsi
Ukraine	Tanvex Investigational Site 1803	Dnepropetrovsk
Ukraine	Tanvex Investigational Site 1824	Dnipro
Ukraine	Tanvex Investigational Site 1820	Kherson
Ukraine	Tanvex Investigational Site 1812	Khmelnytskyi
Ukraine	Tanvex Investigational Site 1802	Kiev
Ukraine	Tanvex Investigational Site 1811	Kiev
Ukraine	Tanvex Investigational Site 1815	Kiev
Ukraine	Tanvex Investigational Site 1814	Kirovogrado
Ukraine	Tanvex Investigational Site 1819	Kropyvnytskyi
Ukraine	Tanvex Investigational Site 1804	Kryvyi Rih
Ukraine	Tanvex Investigational Site 1809	Kyiv
Ukraine	Tanvex Investigational Site 1810	Odesa
Ukraine	Tanvex Investigational Site 1806	Sumy
Ukraine	Tanvex Investigational Site 1822	Ternopil'
Ukraine	Tanvex Investigational Site 1823	Úzhgorod
Ukraine	Tanvex Investigational Site 1818	Vinnitsya
Ukraine	Tanvex Investigational Site 1813	Zaporizhzhia

Sponsors (1)

Lead Sponsor	Collaborator
Tanvex BioPharma USA, Inc.

Countries where clinical trial is conducted

Belarus,  Chile,  Georgia,  Hungary,  India,  Mexico,  Peru,  Philippines,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Objective Response Rate (ORR)	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.	End of Treatment (Week 24) or Early Termination Visit