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.

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01290718
• Other study ID #: ML21833
• Status: Terminated
• Phase: Phase 2
• First received: February 3, 2011
• Last updated: December 15, 2014
• Start date: December 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• capecitabine [Xeloda]
900mg/m2 bid po on days 1-14 of each 3-week cycle
• trastuzumab [Herceptin]
8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Overall Response	The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).	Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death	No
Secondary	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.	Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death	No
Secondary	Overall Survival	Overall survival (OS) is the time from the date of randomization to the date of death irrespective of the cause of death.	Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death	No
Secondary	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.	Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death	No