Back to resultsA Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
capecitabine [Xeloda]
trastuzumab [Herceptin]
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Female patients, 18-65 years of age
- Histologically confirmed HER2-positive breast cancer with measurable lesions (according to RECIST criteria)
- Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with Herceptin and taxanes
- ECOG performance status 0-2
Exclusion Criteria:
- CNS metastases which are not well controlled
- Simultaneous treatment with sorivudine
- History of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
- Pregnant or lactating women
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Overall Response
The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).
Secondary Outcome Measures
Time to Disease Progression
Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded.
Overall Survival
Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death.
Progression-Free Survival
Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01290718
Brief Title
A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.
Official Title
Study of Trastuzumab Combined With Capecitabine on HER2-positive Metastatic Breast Cancer Patients Pretreated With Trastuzumab and Taxanes or HER2- Positive Breast Cancer Patients Relapsed From (Neo)Adjuvant Therapy of Trastuzumab and Taxanes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment
Study Start Date
December 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single arm. open-label study will assess the efficacy and safety of Herceptin (trastuzumab) in combination with Xeloda (capecitabine) in patients with metastatic or recurrent HER2-positive breast cancer, refractory to or relapsing after chemotherapy with Herceptin and taxanes. Patients will receive Xeloda 900mg/m2 twice daily orally on days 1-14 of each 3-week cycle and Herceptin 8mg/kg intravenously (iv) on day 1 of the first cycle followed by 6mg/kg iv every 3 weeks. The anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
900mg/m2 bid po on days 1-14 of each 3-week cycle
Intervention Type
Drug
Intervention Name(s)
trastuzumab [Herceptin]
Intervention Description
8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Overall Response
Description
The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).
Time Frame
Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Secondary Outcome Measure Information:
Title
Time to Disease Progression
Description
Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Time to progression is the time from the date of first dose of drug administration to the date when first disease progression is recorded.
Time Frame
Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Title
Overall Survival
Description
Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death.
Time Frame
Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
Title
Progression-Free Survival
Description
Tumor response was evaluated according to RECIST criteria (version 1.1). Progressive Disease was defined as at least a 20% increase in the sum of LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Participants without progression were censored at the date of last tumor assessment when non progression was documented.
Time Frame
Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female patients, 18-65 years of age
Histologically confirmed HER2-positive breast cancer with measurable lesions (according to RECIST criteria)
Metastatic disease after first-line therapy or recurrent disease after (neo)adjuvant therapy with Herceptin and taxanes
ECOG performance status 0-2
Exclusion Criteria:
CNS metastases which are not well controlled
Simultaneous treatment with sorivudine
History of another malignancy within the last 5 years except for cured basal cell carcinoma of the skin and cured carcinoma in-situ of the uterine cervix
Pregnant or lactating women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Chai Yi
ZIP/Postal Code
613
Country
Taiwan
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
City
Taipei
ZIP/Postal Code
00112
Country
Taiwan
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
City
Taipei
ZIP/Postal Code
105
Country
Taiwan
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
A Study of Herceptin (Trastuzumab) in Combination With Xeloda (Capecitabine) in Patients With Metastatic or Recurrent HER2-positive Breast Cancer After First-Line or (Neo)Adjuvant Therapy.
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