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.

NCT01290718 | Terminated Phase 2 Results

• 1 other identifier: ML21833
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to Disease Progression

  Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death

• Overall Survival

  Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death

• Progression-Free Survival

  Baseline and Day 1 of Cycles 4 and 8 and every 3 weeks until unacceptable toxicity or Death

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: capecitabine [Xeloda]; Drug: trastuzumab [Herceptin]

Interventions

capecitabine [Xeloda] DRUG

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

Single Arm

trastuzumab [Herceptin] DRUG

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

Single Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Chai Yi, 613, Taiwan

Location

Unknown Facility

Kaohsiung City, 807, Taiwan

Location

Unknown Facility

Taipei, 00112, Taiwan

Location

Unknown Facility

Taipei, 100, Taiwan

Location

Unknown Facility

Taipei, 105, Taiwan

Location

Unknown Facility

Taipei, 112, Taiwan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Capecitabine; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2011
• First Posted: February 7, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: December 17, 2014
• Results First Posted: December 17, 2014

Record last verified: 2014-12

Locations

TW (6)