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

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel; Drug: Vinorelbine; Drug: Carboplatin; Drug: Herceptin

• Registration Number: NCT00453635
• Lead Sponsor: Hellenic Oncology Research Group

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.

Detailed 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.

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2007-03-28
• Study First Submitted QC: 2007-03-28
• Study First Posted: 2007-03-29
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-12
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 88

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Herceptin	Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
2	Herceptin	Vinorelbine + Herceptin (VHer)
2	Vinorelbine	Vinorelbine + Herceptin (VHer)
1	Carboplatin	Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)
1	Docetaxel	Docetaxel + Carboplatin + Herceptin (D/Carbo/Her)

Primary Outcome Measures

Name	Time	Method
Time to progression between the two treatment arms	1 year

Secondary Outcome Measures

Name	Time	Method
Toxicity profile	During the time of chemotherpy
Overall survival	1 year

Trial Locations

Locations (10)

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece

University Hospital of Crete; 🇬🇷 Heraklion, Crete, Greece

401 Military Hospital of Athens; 🇬🇷 Athens, Greece

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology; 🇬🇷 Athens, Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology; 🇬🇷 Thessaloniki, Greece

Marika Iliadis" Hospital of Athens, Dep of Medical Oncology; 🇬🇷 Athens, Greece

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece

State General Hospital of Larissa; 🇬🇷 Athens, Greece