Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Antineoplastic Agents, Immunological

Helena R Chang, M.D, Ph.D.

The purpose of the study is to determine what factors affect a patient's decision to accept delayed Herceptin® treatment after completing their surgery and/or chemotherapy and/or radiation therapy.

Women with invasive breast cancer that have a HER-2 positive (FISH +) determination in 2004 or thereafter and who have completed surgery and primary treatment earlier will be potentially eligible.

Patients will be asked to complete a questionnaire about their breast cancer and reasons why they may or may not accept Herceptin® treatment. Patients will be given the option to (1) receive Herceptin® for 52 weeks and have annual doctor visits for 5 years or (2) not to receive Herceptin® but agree to annual doctor visits for 5 years.

Study Phase- Phase II Study Type- Interventional Study Design-

This is an open label, non-randomized phase II study in patients with non-metastatic HER-2 positive breast cancer by FISH diagnosed in 2004 or thereafter. Potential patients will sign a written ICF prior to completing a questionnaire designed to determine what factors may affect a patient's acceptance of Herceptin® treatment. After answering the questionnaire, patients will be given the following options:

1. to receive one year of trastuzumab treatment and annual follow-up for 5 years
2. to decline trastuzumab treatment but serve as a comparison group member for monitoring safety and effectiveness of trastuzumab and to have annual follow-up for 5 years

Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer

A Phase II Trial of Delayed Adjuvant Herceptin® in Patients With HER-2 Positive Breast Cancer

Jonsson Comprehensive Cancer Center

Herceptin (trastuzumab)

SB3 (proposed trastuzumab biosimilar)

A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC

A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC

Asymptomatic significant LVEF decrease is defined as LVEF decline ≥ 10% points from baseline and resulting LVEF \< 50%

Samsung Bioepis Co., Ltd.

For any type of serious AE (SAE; cardiac or non-cardiac) that could be determined by the Investigator to be related to the IP then that SAE was reported through a separate paper SAE report form to the Sponsor.

Intravenous administration Herceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

Herceptin (Trastuzumab)

Intravenous administration SB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

SB3 (Proposed Trastuzumab Biosimilar)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Director of Clinical Trials

Intravenous administration

Herceptin (trastuzumab): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

Intravenous administration

SB3 (proposed trastuzumab biosimilar): Intravenous administration in SB3-G31-BC study (NCT02149524). No additional IP was administered for this study since it was an observational study.

Number of Subjects With Asymptomatic Significant LVEF Decrease

Overall Study

Carcinoma

Carcinoma, Ductal

Carcinoma in Situ

Carcinoma, Intraductal, Noninfiltrating

Breast Carcinoma In Situ

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

8 mg/kg intravenously (IV) Over 90 Minutes

Henry Kuerer, MD, PhD

Primary Objectives:

* To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS)
* To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS

Herceptin (Trastuzumab) stops or slows the growth of certain breast cancer cells by blocking the chemical signals they need to grow.

As part of your standard care for DCIS, you will have a complete routine physical exam, a mammogram of both breasts, and blood (about 2 tablespoons) will be drawn for routine tests. Some of your leftover breast biopsy tissue will be tested for Her-2/neu expression. Blood will be drawn (about 2-6 teaspoons) to check if your bone marrow (red blood cells), kidney, and liver are functioning well enough to have this treatment. Women who are able to have children must have a negative blood pregnancy test before starting treatment.

If you are eligible to take part in this study, you will receive one dose of trastuzumab at least 2 weeks before your surgery. The dose of trastuzumab will be given intravenously (through a needle in a vein in your arm) as a steady infusion over 90 minutes, on an outpatient basis. You will be checked during the infusion and for 1 hour after it is completed.

You will have routine surgery for DCIS (either segmental mastectomy, mastectomy with or without reconstruction, and possible sentinel lymph node biopsy) approximately 14 to 28 days after being given Herceptin. If a segmental mastectomy was performed as part of our standard practice you will be evaluated by a radiation oncologist following surgery. After your surgery, patients will also be evaluated by a breast medical oncologist to determine if any additional standard therapy is needed.

Tissue that is left over from the original breast biopsy and surgery will be tested for various biomarkers (substances which indicate the severity or spread of cancer), cancer growth rate, and apoptotic index (cell death rate).

This is an investigational study. The FDA has approved trastuzumab for the treatment of breast cancer. Up to 71 patients will take part in this study. All will be enrolled at M. D. Anderson.

Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.

Proliferation rate and apoptotic index measured on core biopsy specimen and resection specimen from each participants. To compare Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and CD4+ T-cell response in each participant observed at pre- and post-treatment times, paired analysis was performed using Student's t-test. Nonparametric Wilcoxon rank sum test was used to compare data between groups.

Mean percent of Ki-67 (% nuclei stained) at immunohistochemical staining performed for biomarkers. Tissue sections from diagnostic core biopsy tissue that contains DCIS before treatment and from corresponding tissues that contain DCIS from the surgical resection obtained after a single dose of Herceptin.

M.D. Anderson Cancer Center

Herceptin

Age, Continuous

United States

Region of Enrollment

Raphael E Pollock,PHD/Professor Emeritus, Surgical Oncology

Percent Change in Proliferation as Measured by Ki-67

Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.

Number of Participants Achieving Documented Change in Proliferation

Analysis was per protocol. Twelve evaluable patients were required to characterize the change in proliferation rate after treatment with a single dose of Herceptin (trastuzumab). Those participants who completed Herceptin administration, surgery, and post surgery bio-markers testing were evaluable.

Mean Percent of Ki-67

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)

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)

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer	NCT00427427	Breast Cancer	Trastuzumab	18 Years -	Jonsson Comprehensive Cancer Center
Delayed Adjuvant Herceptin® Treatment in Patients With HER-2 Positive Breast Cancer	NCT00427427	Breast Cancer	Trastuzumab	18 Years -	Jonsson Comprehensive Cancer Center
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC	NCT02771795	Breast Neoplasm...	Herceptin (tras... SB3 (proposed t...	18 Years -	Samsung Bioepis Co., Ltd.
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast	NCT00496808	Ductal Carcinom...	Herceptin (Tras...	-	M.D. Anderson Cancer Center
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast	NCT00496808	Ductal Carcinom...	Herceptin (Tras...	-	M.D. Anderson Cancer Center
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.
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC	NCT02771795	Breast Neoplasm...	Herceptin (tras... SB3 (proposed t...	18 Years -	Samsung Bioepis Co., Ltd.
Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast	NCT00496808	Ductal Carcinom...	Herceptin (Tras...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for herceptin (trastuzumab)