Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients

NCT00453635 | Terminated Phase 2

• 1 other identifier: CT/03.08
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 10

Brief Summary

This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with metastatic breast cancer.

Conditions

Breast Cancer

Keywords

Cancer; Breast cancer; First line treatment; Docetaxel; Carboplatin; Herceptin; Vinorelbine

Outcome Measures

Primary Outcomes (1)

• Time to progression between the two treatment arms

  1 year

Secondary Outcomes (2)

• Overall survival

  1 year

• Toxicity profile

  During the time of chemotherpy

Study Arms (2)

1

EXPERIMENTAL

Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)

Drug: Docetaxel; Drug: Carboplatin; Drug: Herceptin

2

EXPERIMENTAL

Vinorelbine + Herceptin (VHer)

Drug: Herceptin; Drug: Vinorelbine

Interventions

Docetaxel DRUG

Docetaxel at the dose of 75mg/m\^2 IV on day 1 every 3 weeks for 6 consecutive cycles

Also known as: Taxotere

1

Carboplatin DRUG

Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles

1

Herceptin DRUG

Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks

1; 2

Vinorelbine DRUG

Vinorelbine at the dose of 60mg/m\^2 per os,weekly

Also known as: Navelbine

2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Performance status (WHO) 0-2
• Histologically confirmed metastatic breast adenocarcinoma (stage IV) without any prior chemotherapy received
• HER-2 overexpression 2+ or 3+ using IHC or FISH +
• Measurable disease not in a prior irradiation field (no other concurrent chemotherapy agents)
• No more than 25% of myeloproductive bone marrow irradiated (more than 4 weeks since prior radiotherapy and recovered)
• More than 6 months since prior adjuvant or neoadjuvant chemotherapy and recovered
• No prior first line chemotherapy for metastatic disease
• Endocrine therapy is allowed as adjuvant or first line treatment for metastatic disease
• Paraffin block from the primary tumor available in the research lab
• Adequate bone marrow function (absolute neutrophil count \> 1000/mm\^3, platelet count \> 100000/mm\^3, hemoglobin \> 9 gr/mm\^3)
• Adequate liver (Bilirubin \< 1.5 times upper limit of normal and SGOT/SGPT \< 2 times upper limit of normal) and renal function (creatinine \< 2mg/dl)
• Adequate cardiac function (LVEF \> 50%)
• Informed consent

You may not qualify if:

• Pregnant or nursing
• Concurrent agents ketoconazole, macrolide antibiotics, zidovudine which may induce P-450 cytochrome
• Positive pregnancy test
• Motor or sensory neuropathy \> grade 1 according to NCIC Τoxicity Criteria
• Patients with brain metastatic disease who has not been irradiated or uncontrolled brain metastatic disease after irradiation
• History of allergic reaction attributed to docetaxel
• Psychiatric illness or social situation that would preclude study compliance
• Other concurrent uncontrolled illness.
• Other invasive malignancy within the past 5 years except cured basal cell skin carcinoma and cervical carcinoma in situ

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (10)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, Greece

Location

State General Hospital of Larissa

Athens, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Docetaxel; Carboplatin; Trastuzumab; Vinorelbine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Dimitris Mavroudis, MD

  University Hospital of Crete, Dep of Medical Oncology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 28, 2007
• First Posted: March 29, 2007
• Study Start: December 1, 2003
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

GR (10)