Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Antineoplastic Agents, Immunological

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.

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.

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.

Subjects will receive up to 13 cycles of adjuvant treatment.

TX05 (trastuzumab)

Herceptin (trastuzumab)

Bonnie Mills, PhD

This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and surgical resection in Protocol TX05-03.

Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

A Double-blinded Extension Study to Provide Adjuvant Treatment With Single Agent Herceptin® or TX05 and Assess Continued Safety and Immunogenicity in Subjects With HER2-positive Early Breast Cancer Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03

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.

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.

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

Tanvex BioPharma USA, Inc.

Ongoing drug-related AEs and SAEs from the neoadjuvant study (Protocol TX05-03) and any SAEs that occurred after completion of the neoadjuvant study were recorded at Screening in the subject's medical history, while AEs occurring in this extension study were recorded from Day 1 (Week 0) of Cycle 1 of study treatment.

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.

Test Product (TX05 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.

Reference Therapy (Herceptin 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 Herceptin on the TX05-03 study and were randomized to receive TX05 in this extension study.

Test Product (Herceptin/TX05 Transition)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Hormone Receptor Status

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.

Tumor Stage

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

ECOG

Study Director

Baseline

Cycle 6 Week 15

End of Study/Early Terminiation

Immunogenicity Assessments (ADA and Nab)

Disease-Free Survival

Overall Survival

Overall Study

Antirheumatic Agents

Anti-Infective Agents

Paclitaxel

Cyclophosphamide

Albumin-Bound Paclitaxel

Epirubicin

Tubulin Modulators

Antimitotic Agents

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

• 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

• 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

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

Herceptin®

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

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

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

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.

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

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

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).

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.

Because study drug (TX05/trastuzumab) was not introduced until Cycle 5 of treatment, the analyses of AEs was focused on Cycles 5 through 8 of treatment. The following results include events that occurred on or after initiation of TX05 or Herceptin treatment.

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

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)

TX05 (Trastuzumab)

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

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)

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

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

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

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

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

Grade 5: Dead

* Enrolled subjects should have Stage II/IIIa breast cancer.
* Stage will be determined by the American Joint Committee on Cancer (AJCC) TNM (tumor size, lymph node involvement, metastasis to distant sites) staging system.
* A low grade number (grade 1) usually means the cancer is slower-growing and less likely to spread. A high grade number (grade 3) means a faster-growing cancer that's more likely to spread. An intermediate grade number (grade 2) means the cancer is growing faster than a grade 1 cancer but slower than a grade 3 cancer.

Safety population/The modified intent-to-treat (mITT) population includes all subjects who are randomized into the study and receive at least 1 dose of TX05 or Herceptin.

Subjects who do not Meet pCR Criteria

Subjects Meeting pCR Criteria

Per Protocol Population \[includes all subjects who received at least one dose of study drug (TX05 or Herceptin) and had no major protocol deviations that impact the efficacy endpoints\].

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

This analysis was performed on the modified intent-to-treat population. The modified intent-to-treat (mITT) population includes all subjects who were randomized and received at least 1 dose of TX05 or Herceptin.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03	NCT04109391	HER2-positive B... Early-stage Bre... Breast Cancer Breast Neoplasm... Stage II Breast... Stage IIIA Brea...	TX05 (trastuzum... Herceptin (tras...	18 Years -	Tanvex BioPharma USA, Inc.
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer	NCT03556358	Breast Cancer Breast Neoplasm... HER2-positive B... Stage II Breast... Stage IIIA Brea...	TX05 (trastuzum... Herceptin® Paclitaxel Epirubicin Cyclophosphamid...	18 Years -	Tanvex BioPharma USA, Inc.
Trial to Compare the Safety, Efficacy and Immunogenicity of TX05 With Herceptin® in HER2+ Early Breast Cancer	NCT03556358	Breast Cancer Breast Neoplasm... HER2-positive B... Stage II Breast... Stage IIIA Brea...	TX05 (trastuzum... Herceptin® Paclitaxel Epirubicin Cyclophosphamid...	18 Years -	Tanvex BioPharma USA, Inc.

Spots Global Cancer Trial Database for tx05 (trastuzumab)