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

Breast Cancer Clinical Trial

Official title:

A Multicenter Randomized Phase II Study of First Line Treatment With Sequential Administration of Docetaxel, Carboplatin and Herceptin Versus the Administration of Vinorelbine and Herceptin Combination in HER-2 Positive Patients With Metastatic Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00453635
• Other study ID #: CT/03.08
• Status: Terminated
• Phase: Phase 2
• First received: March 28, 2007
• Last updated: March 12, 2012
• Start date: December 2003
• Est. completion date: November 2008

Study information

• Verified date: March 2012
• Source: Hellenic Oncology Research Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Interventional

Clinical Trial 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.

Description:

Herceptin, a humanized monoclonal antibody directed against the extracellular domain of the transmembrane glycoprotein HER2/neu (c-erbB-2), is a valuable option in the treatment of women with HER2-positive metastatic breast cancer. The combination of Herceptin and chemotherapy yielded significantly better results than chemotherapy alone in response, time to progression, and survival time. Whether the combination of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination in HER-2 positive patients with metastatic breast cancer is preferable is not yet known.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 ?oxicity 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Docetaxel
Docetaxel at the dose of 75mg/m^2 IV on day 1 every 3 weeks for 6 consecutive cycles
• Carboplatin
Carboplatin at the dose of 5 AUC IV on day 1 every 3 weeks for 6 consecutive cycles
• Herceptin
Herceptin 8 mg/Kg on day 1 for the first cycle and 6 mg/Kg for the 5 remaining cycles, IV, every 3 weeks
• Vinorelbine
Vinorelbine at the dose of 60mg/m^2 per os,weekly

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis, Dep of Medical Oncology	Alexandroupolis
Greece	"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Athens
Greece	"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Athens
Greece	401 Military Hospital of Athens	Athens
Greece	Air Forces Military Hospital of Athens	Athens
Greece	Marika Iliadis" Hospital of Athens, Dep of Medical Oncology	Athens
Greece	State General Hospital of Larissa	Athens
Greece	University Hospital of Crete	Heraklion	Crete
Greece	"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Piraeus
Greece	"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Hellenic Oncology Research Group	University Hospital of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression between the two treatment arms		1 year	No
Secondary	Overall survival		1 year	No
Secondary	Toxicity profile		During the time of chemotherpy	Yes