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.

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: capecitabine [Xeloda]; Drug: trastuzumab [Herceptin]

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • Chai Yi, Taiwan, 613
  • Kaohsiung, Taiwan, 807
  • Taipei, Taiwan, 100
  • Taipei, Taiwan, 112
  • Taipei, Taiwan, 00112
  • Taipei, Taiwan, 105

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (ACTUAL): December 1, 2012
• Study Completion (ACTUAL): December 1, 2012

Study Registration Dates

• First Submitted: February 3, 2011
• First Submitted That Met QC Criteria: February 4, 2011
• First Posted (ESTIMATE): February 7, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): December 17, 2014
• Last Update Submitted That Met QC Criteria: December 15, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Antineoplastic Agents, Immunological; Trastuzumab; Capecitabine
• Other Study ID Numbers: ML21833