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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.

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ClinicalTrials.gov Identifier: NCT01290718
Recruitment Status : Terminated (Slow recruitment)
First Posted : February 7, 2011
Results First Posted : December 17, 2014
Last Update Posted : December 17, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: capecitabine [Xeloda] Drug: trastuzumab [Herceptin] Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : December 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. Percentage of Participants With Overall Response [ Time Frame: 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 :
  1. Time to Disease Progression [ Time Frame: 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.

  2. Overall Survival [ Time Frame: 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.

  3. Progression-Free Survival [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01290718


Locations
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Taiwan
Chai Yi, Taiwan, 613
Kaohsiung, Taiwan, 807
Taipei, Taiwan, 00112
Taipei, Taiwan, 100
Taipei, Taiwan, 105
Taipei, Taiwan, 112
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01290718     History of Changes
Other Study ID Numbers: ML21833
First Posted: February 7, 2011    Key Record Dates
Results First Posted: December 17, 2014
Last Update Posted: December 17, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Trastuzumab
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Immunological