Benefit of Adding Trastuzumab to Second Line Chemotherapy in Breast Cancer Patients Previously Treated With Trastuzumab

NCT00130507 | Terminated Phase 2

• 1 other identifier: GEICAM 2004-06
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Eligible patients must receive vinorelbine plus capecitabine, with or without trastuzumab, until disease progression or unbearable toxicity. Cycles will be administered every 3 weeks.Human epidermal growth factor receptor 2 (HER2) status must be locally assessed by immunohistochemistry (IHC). All 3+ patients are eligible. In 2+ patients, HER2 status must be confirmed by fluorescence in situ hybridization (FISH).

Conditions

Breast Cancer

Keywords

HER2 positive breast cancer.; Progression to trastuzumab and taxanes.

Outcome Measures

Primary Outcomes (1)

• Clinical benefit rate

  Clinical benefit rate is defined as the rate of objective responses (complete responses and partial responses to treatment) and stabilizations, with a minimum duration of 24 weeks.

  Through study completion, an average of 1 year

Secondary Outcomes (5)

• Time to progression (TTP)

  Through study completion, an average of 1 year

• Objective Response Rate (ORR)

  Through study completion, an average of 1 year

• Response Duration (RD)

  Through study completion, an average of 1 year

• The Number of Participants Who Experienced Adverse Events (AE)

  Through study completion, an average of 1 year

• Overall Survival (OS)

  Through study completion, an average of 1 year

Study Arms (2)

Arm A: VX

ACTIVE COMPARATOR

Vinorelbine and capecitabine (VX): vinorelbine 25 mg/m2 iv, days 1 and 8 each cycle (21 days), followed of capecitabine 825 mg/m2, orally, twice a day, days 1-14 each cycle (21 days).

Drug: Vinorelbine; Drug: Capecitabine

Arm B: VXH

EXPERIMENTAL

Vinorelbine, capecitabine and trastuzumab (VXH): vinorelbine 25 mg/m2 iv, days 1 and 8 each cycle (21 days), followed of capecitabine 825 mg/m2, orally, twice a day, days 1-14 each cycle (21 days) and trastuzumab 4 mg/kg iv (loading dose first week), followed by 2 mg/kg weekly.

Drug: Vinorelbine; Drug: Capecitabine; Drug: Trastuzumab

Interventions

Vinorelbine DRUG

Also known as: Navelbine

Arm A: VX; Arm B: VXH

Capecitabine DRUG

Also known as: Xeloda

Arm A: VX; Arm B: VXH

Trastuzumab DRUG

Also known as: Herceptin

Arm B: VXH

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Women older than 18 years old.
• HER2 positive breast cancer with histological diagnoses.
• Non-operable locally advanced or metastatic disease, previously treated with trastuzumab and taxanes.
• Measurable or non-measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST).
• Disease progression during or after treatment with trastuzumab and taxanes.
• Maximum of 1 previous chemotherapy line for advanced or metastatic disease.
• Previous radiotherapy is allowed if radiated area is not the only documented lesion.
• At least 4 weeks since the last administration of antineoplastic treatment and all toxicities resolved.
• Performance status Eastern Cooperative Oncology Group (ECOG) \>=2.
• Life expectancy of at least 12 weeks.
• Left Ventricular Ejection Fraction (LVEF) evaluation (\>=50%) in previous 4 weeks.
• Hematology:
• neutrophils \>=1.5 x 10e9/l;
• platelets \>= 100 x 10e9/l;

You may not qualify if:

• History of hypersensitivity to vinorelbine, trastuzumab, rat proteins or trastuzumab components.
• History of dyspnea at rest, or chronic oxygen therapy required.
• Active infection.
• Second malignancy, except for cervical in situ carcinoma, basal skin carcinoma, adequately treated. Previous malignancies with a 5 year disease free survival are allowed.
• Pregnant or lactating women.
• Any other serious medical pathology, such as congestive heart failure, unstable angina, history of myocardial infarction during the previous year, uncontrolled hypertension or high risk arrhythmias.
• History of neurological or psychiatric disorders, which could preclude the patients to free informed consent.
• Active uncontrolled infection.
• Active peptic ulcer, unstable diabetes mellitus.
• Concomitant treatment with other investigational products. Participation in other clinical trials with a non-marketed drug in the 30 previous days before randomization.
• Concomitant treatment with other therapy for cancer.

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• Hoffmann-La Roche: collaborator

Study Sites (1)

Spanish Breast Cancer Research Group (GEICAM)

San Sebastián de los Reyes, Madrid, 28700, Spain

Location

Related Links

• Click here for more information about this study.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine; Capecitabine; Trastuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; 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

Study Officials

• Study Director

  Hospital Clinic i Provincial

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2005
• First Posted: August 15, 2005
• Study Start: November 4, 2005
• Primary Completion: June 1, 2009
• Study Completion: July 25, 2009
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

ES (1)