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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.

NCT ID: NCT01290718

Last Updated: 2014-12-17

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-12-31

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Arm

Group Type EXPERIMENTAL

capecitabine [Xeloda]

Intervention Type DRUG

900mg/m2 bid po on days 1-14 of each 3-week cycle

trastuzumab [Herceptin]

Intervention Type DRUG

8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks

Interventions

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capecitabine [Xeloda]

900mg/m2 bid po on days 1-14 of each 3-week cycle

Intervention Type DRUG

trastuzumab [Herceptin]

8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Chai Yi, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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ML21833

Identifier Type: -

Identifier Source: org_study_id