Extension Study to Provide Adjuvant Treatment Following N... | NCT04109391

NCT04109391

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Product (TX05)	Experimental	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.	Biological: TX05 (trastuzumab)
Reference Therapy (Herceptin)	Active Comparator	IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive Herceptin in this extension study.	Biological: Herceptin (trastuzumab)
Test Product (Herceptin/TX05 Transition)	Experimental	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.	Biological: TX05 (trastuzumab)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TX05 (trastuzumab)	Biological	Subjects will receive up to 13 cycles of adjuvant treatment.	Test Product (Herceptin/TX05 Transition) Test Product (TX05)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Immunogenicity Assessments (ADA and Nab)	Samples for the evaluation of anti-drug antibodies (ADA), including neutralizing antibodies (Nab) were obtained before the administration of Cycle 1 (Week 0), Cycle 6 (Week 15), and the EOT/ET Visit. Only subjects with a positive ADA result were further tested for ADA cross-reactivity and Nab. Only subjects with a positive Nab result were further tested for Nab cross-reactivity.	Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.
Disease-Free Survival	DFS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) to the documentation of a first failure, where a failure was the recurrence of breast cancer or a diagnosis of a second primary cancer.	Through study completion/end of treatment (Week 45).
Overall Survival	OS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) until death from any cause.	Through study completion/end of treatment (Week 45).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed written informed consent.
Females ≥ 18 years of age.
Completed neoadjuvant treatment (regardless of treatment arm) in the TX05/ Herceptin neoadjuvant study and the investigator believes the subject requires continued access to single agent trastuzumab in order to continue deriving clinical benefit.
Successfully undergone surgical resection of their primary tumor with no evidence of residual disease (as determined by local assessment) and no other adjuvant therapy, other than trastuzumab, is planned. However, subjects will be allowed to receive hormonal therapy if they have hormone receptor positive tumors. Subjects will also be allowed to receive adjuvant radiation therapy, if required by their treating physician.
Able to comply with the study protocol.
Female subjects of childbearing potential must have a negative serum pregnancy test within 14 days of first administration of study drug and agree to use effective contraception (hormonal contraceptive, intrauterine device, diaphragm with spermicide, or condom with spermicide) throughout the study period and for 7 months after last administration of study drug.

Exclusion Criteria:

Breast cancer metastases or residual disease post operatively (as determined by local assessment).
History or presence of a medical condition or disease that in the investigator's opinion would place the subject at an unacceptable risk for study participation.
Lactating or pregnant female.
Women of childbearing potential who do not consent to use highly effective methods of birth control (e.g. true abstinence [periodic abstinence {e.g. calendar ovulation, symptothermal, post-ovulation methods} and withdrawal are not acceptable methods of contraception], sterilization, or other non-hormonal forms of contraception) during treatment and for at least 7 months after the last administration of study drug. Subjects must agree to not breast-feed while receiving study drug.
Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.

Name	Affiliation	Role
Bonnie Mills, PhD	Tanvex BioPharma USA, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Tanvex Investigational Site 1006E		Grodno		230017	Belarus
Tanvex Investigational Site 1003E

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Test Product (TX05 Only)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 13, 2018	Oct 4, 2022

Arm/Group Information

ID	Title	Description
BG000	Test Product (TX05 Only)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
BG001	Reference Therapy (Herceptin Only)	IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
BG002	Test Product (Herceptin/TX05 Transition)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.3± 11.43 BG00153.7± 10.12 BG00254.0± 10.71 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000175 BG00182 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00029 BG00112 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0005 BG0011 BG002

Hormone Receptor Status

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Positive	BG000100 BG00150 BG002

Tumor Stage

Enrolled subjects should have Stage II/IIIabreast cancer.

Stage will be determined by the American Joint Committee onCancer (AJCC) TNM (tumor size, lymph node involvement,metastasis to distant sites) staging system.

A low grade number (grade 1) usually means the cancer isslower-growing and less likely to spread. A high grade number(grade 3) means a faster-growing cancer that's more likely tospread. An intermediate grade number (grade 2) means thecancer is growing faster than a grade 1 cancer but slower than agrade 3 cancer.

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Stage IIa	BG00065 BG001

ECOG

Grade 0: Fully active, able to carry on all pre-disease activities without restriction

Grade 1: Restricted in physically strenuous activity but ambulatory andable to carry out work of a light or sedentary nature.

Grade 2: Ambulatory and capable of all self-care but unable to carryout any work activities. Up and about more than 50% of waking hours.

Grade 3: Capable of only limited self-care, confined to bed or chairmore than 50% of waking hours.

Grade 4: Completely disabled. Cannot carry on any self-care. Totallyconfined to bed or chair.

Grade 5: Dead

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Grade 0	BG000142 BG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Immunogenicity Assessments (ADA and Nab)

Samples for the evaluation of anti-drug antibodies (ADA), including neutralizing antibodies (Nab) were obtained before the administration of Cycle 1 (Week 0), Cycle 6 (Week 15), and the EOT/ET Visit. Only subjects with a positive ADA result were further tested for ADA cross-reactivity and Nab. Only subjects with a positive Nab result were further tested for Nab cross-reactivity.

Posted

Count of Participants

Participants

Assessed from first infusion through end of treatment (Week 45) or Early Termination visit. Each cycle is 3 weeks.

ID	Title	Description
OG000	Test Product (TX05 Only)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
OG001	Reference Therapy (Herceptin Only)	IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
OG002	Test Product (Herceptin/TX05 Transition)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.

Units	Counts
Participants	OG000175 OG00182 OG00281

Title

Denominators

Categories

Baseline

Title	Measurements
ADA Positive	OG0003 OG0012 OG0023
Nab Positive

Primary

Disease-Free Survival

DFS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) to the documentation of a first failure, where a failure was the recurrence of breast cancer or a diagnosis of a second primary cancer.

Posted

Count of Participants

Participants

Through study completion/end of treatment (Week 45).

ID	Title	Description
OG000	Test Product (TX05 Only)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
OG001	Reference Therapy (Herceptin Only)	IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
OG002	Test Product (Herceptin/TX05 Transition)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.

Primary

Overall Survival

OS, defined as the time from randomization in the neoadjuvant study (Protocol TX05-03) until death from any cause.

Posted

Count of Participants

Participants

Through study completion/end of treatment (Week 45).

ID	Title	Description
OG000	Test Product (TX05 Only)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.
OG001	Reference Therapy (Herceptin Only)	IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.
OG002	Test Product (Herceptin/TX05 Transition)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Test Product (TX05 Only)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received TX05 on the TX05-03 study and continued to receive TX05 in this extension study.	0	175	4	175	49	175
EG001	Reference Therapy (Herceptin Only)	IV trastuzumab (Herceptin) TX05 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles Herceptin (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and continued to receive Herceptin in this extension study.	0	82	3	82	15	82
EG002	Test Product (Herceptin/TX05 Transition)	IV trastuzumab (TX05) 8 mg/kg loading dose and then 6 mg/kg every 3 weeks for up to 13 cycles TX05 (trastuzumab): Subjects will receive up to 13 cycles of adjuvant treatment. These subjects received Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.	1	81	2	81	15	81

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
COVID-19	Infections and infestations	Systematic Assessment	EG0002 events2 affected175 at risk EG0010 events0 affected82 at risk EG0020 events0 affected81 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected82 at risk EG0020 events0 affected81 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Systematic Assessment	EG0001 events1 affected175 at risk EG0010 events0 affected82 at risk EG0020 events0 affected81 at risk
Gastrointestinal infection/	Infections and infestations	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected82 at risk EG0020 events0 affected81 at risk
Femoral neck fracture/	Injury, poisoning and procedural complications	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected82 at risk EG0020 events0 affected81 at risk
COVID-19 pneumonia	Infections and infestations	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected82 at risk EG0020 events0 affected81 at risk
Hepatic failure	Hepatobiliary disorders	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected82 at risk EG0021 events1 affected81 at risk
Ischaemic stroke	Nervous system disorders	Systematic Assessment	EG0000 events0 affected175 at risk EG0010 events0 affected82 at risk EG0021 events1 affected81 at risk
Renal Colic	Renal and urinary disorders	Systematic Assessment	EG0000 events0 affected175 at risk EG0011 events1 affected82 at risk EG0020 events0 affected81 at risk

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Respiratory Tract Infection	Infections and infestations	Systematic Assessment	EG0006 events6 affected175 at risk EG0012 events2 affected82 at risk EG0025 events5 affected81 at risk
Alanine Aminotransferase Increased	Investigations	Systematic Assessment	EG00011 events10 affected175 at risk EG0016 events2 affected82 at risk EG0021 events1 affected81 at risk
Aspartate Aminotransferase Increased	Investigations	Systematic Assessment	EG00010 events9 affected175 at risk EG0013 events1 affected82 at risk EG0023 events3 affected81 at risk
Headache	Nervous system disorders	Systematic Assessment	EG00013 events9 affected175 at risk EG0018 events5 affected82 at risk EG0024 events3 affected81 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	Systematic Assessment	EG0008 events7 affected175 at risk EG0015 events5 affected82 at risk EG0022 events2 affected81 at risk
Asthenia	General disorders	Systematic Assessment	EG00012 events10 affected175 at risk EG0014 events4 affected82 at risk EG0024 events3 affected81 at risk
Radiation Skin Injury	Injury, poisoning and procedural complications	Systematic Assessment	EG00013 events13 affected175 at risk EG0015 events5 affected82 at risk EG0020 events0 affected81 at risk

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins