Submitted by: Sarah Jane M. Patoc 2018-11-19 00:00:00 Last Updated by: Jeverly Ann S. Principe 2018-11-20 08:47:35 Export to PDF

An extension study to provide treatment with Herceptin® or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following core study TX05-03.

PHRR181120-001984

TX05-03E

2018-CT0447

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

This is an extension study for subjects who were treated in the prior TX05/Herceptin neoadjuvant study (Protocol TX05-03) and successfully underwent surgical resection. Eligible subjects will receive adjuvant treatment with single agent Herceptin or TX05 for up to 10 treatment cycles.

Start Date Duration in Months Target Completion Date Actual Completion Date
2019-02-01 24 2021-02-01 0000-00-00

Pending

Pending site activation

Institution Classification Region LTO #
Tanvex Biologics Corporation None None NA
Institution Amount Region
Tanvex Biologics Corporation N/A None
Name E-Mail Phone Number Postal Address
Sarah Jane Patoc sarah.patoc@iconplc.com +632 2305700 ICON Clinical Research Services Inc.- 24th Floor, Salcedo Towers, 169 H.V. Dela Costa St., Salcedo Village, Makati City, Philippines 1227
Name E-Mail Phone Number Postal Address
Jennifer Lai Jennifer.Lai@tanvex.com 1-949-483-8507 33F, No. 99, Sec 1, Xintai 5th Street, Xizhi District, New Taipei City 221 Taiwan
Name Expertise Affiliation
Gracieux Fernando, MD Oncology Manila Doctors Hospital
Matthew Yap, MD Oncology Chong Hua Hospital
Jerry Tan Chun Bing, MD Oncology Cebu Doctors' University Hospital
Adonis Guancia, MD Oncology Corazon Locsin Montelibano Memorial Regional Hospital
Irisyl Orolfo-Real, MD Oncology Philippine General Hospital
Annielyn Beryl Ong-Cornel, MD Oncology Veterans Memorial Medical Center
Necy Juat, MD Oncology National Kidney and Transplant Institute
Rosalinda Pulido, MD Oncology St. Frances Cabrini Medical Center
Ellie May Villegas, MD Oncology Perpetual Succour Hospital
Chita Matunog Oncology San Pedro Hospital of Davao City, Inc.
Priscilla B. Caguioa, MD Oncology St. Luke's Medical Center - Quezon City
Regina Edusma-Dy, MD Oncology Makati Medical Center
Project Location Institutional Ethics Review Board
Manila Doctors Hospital Manila Doctors Hospital Institutional Review Board
Chong Hua Hospital Chong Hua Hospital Ethics Review Committee
Cebu Doctors' University Hospital Cebu Doctors' University Hospital - Institutional Ethics Review Committee
Corazon Locsin Montelibano Memorial Regional Hospital CLMMRH - RERC
Philippine General Hospital Philippine General Hospital Ethics Review Board
Veterans Memorial Medical Center Veterans Memorial Medical Center Ethics Review Committee
National Kidney and Transplant Institute National Kidney and Transplant Institute Ethics Review Committee
St. Frances Cabrini Medical Center N/A
Perpetual Succour Hospital Perpetual Succour Hospital Institutional Ethics and Review Board
San Pedro Hospital of Davao City, Inc. San Pedro Hospital of Davao City, Inc. Bioethics Committee
St. Luke's Medical Center - Quezon City St. Luke's Medical Center Institutional Ethics Review Committee
Makati Medical Center Makati Medical Center Institutional Review Board

HER-2 positive breast cancer 

Main Objective: 
• To collect safety, tolerability, and immunogenicity data for single agent Herceptin or TX05 in the adjuvant setting in subjects with early HER2-positive breast cancer who completed neoadjuvant treatment and primary resection in Protocol TX05-03.
• To collect safety, tolerability, and immunogenicity data following a single transition from neoadjuvant Herceptin to adjuvant TX05 in this population.
• To collect disease-free survival (DFS) and overall survival (OS) data in this population.
 
Primary end point(s): Safety Endpoints:
• TEAEs and SAEs.
• Death.
• Clinical laboratory parameters.
• Vital signs.
• 12-lead ECG. 
• LVEF.
• Physical examination.
 
Immunogenicity Endpoints:
• Incidence of ADA.
• Incidence of Nab.
 
Efficacy Endpoints
• DFS, defined as the time from randomization in the neoadjuvant study (Protocol TX05 03) to the documentation of a first failure, where a failure is 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.
 

Secondary Objective: Not applicable
 
Timepoint(s) of evaluation of this end point: Safety Endpoints:
Refer to table 9-1 of the protocol.
 
Immunogenicity Endpoints:
Visit 1, visit 6 and end of study visit.
 
Efficacy Endpoints:
After end of study. No interim analysis is planned.

Pending

  • Belarus
  • Brazil
  • Bulgaria
  • Chile
  • Georgia
  • Hungary
  • India
  • Italy
  • Peru
  • Philippines
  • Poland
  • Romania
  • Russia
  • Slovakia
  • South Korea
  • Spain
  • Thailand
  • Turkey
  • Ukraine

Clinical Trial

2018-CT0447

2018-10-17

None

Inclusion criteria: 
1. Signed written informed consent.
2. Females = 18 years of age.
3. 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.
4. Successfully undergone surgical resection of their primary tumor with no evidence of residual disease, as determined by central review and no other adjuvant therapy, other than trastuzumab, is planned.
5. Able to comply with the study protocol.
6. 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: 
1. Breast cancer metastases or residual disease post operatively.
2. 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.
3. Lactating or pregnant female.
4. 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.
5. Any condition that in the opinion of the Investigator represents an obstacle for study conduct and/or represents a potential unacceptable risk for subjects.

Observational

Unspecified

Unspecified

Randomized

Double Blind

Unspecified

Parallel

• To collect safety, tolerability, and immunogenicity data for single agent Herceptin or TX05 in the adjuvant setting in subjects with early human epidermal growth factor receptor (HER2)-positive breast cancer who
completed neoadjuvant treatment and primary resection in Protocol TX05-03.
• To collect safety, tolerability, and immunogenicity data following a single transition from neoadjuvant Herceptin to adjuvant TX05 in this population.
• To collect disease-free survival (DFS) and overall survival (OS) data in this population.

Phase III

330

24

Unspecified

01 Feb 2019

Utilization Utilization Info
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