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.

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: capecitabine [Xeloda]; Drug: trastuzumab [Herceptin]

• Registration Number: NCT01290718
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-04
• Study First Posted: 2011-02-07
• Study Start: 2011-12
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2014-12
• Results First Submitted: 2014-12-03
• Results First Submitted QC: 2014-12-15
• Last Update Submitted: 2014-12-15
• Results First Posted: 2014-12-17
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	trastuzumab [Herceptin]	-
Single Arm	capecitabine [Xeloda]	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Overall Response	Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death	The tumor response was measured according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria (Version 1.1).

Secondary Outcome Measures

Name	Time	Method
Time to Disease Progression	Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death	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	Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death	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	Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death	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.