Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00615602
First received: February 1, 2008
Last updated: June 10, 2013
Last verified: June 2013
  Purpose

This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive breast cancer overexpressing HER2


Condition Intervention Phase
Breast Cancer
Drug: Docetaxel
Drug: Trastuzumab
Drug: Epirubicin
Drug: Cyclophosphamide
Drug: 5-fluoruracil
Drug: Granulocyte-colony stimulating growth factor
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Phase III Study Comparing 6 Versus 12 Months of Trastuzumab in Combination With Dose Dense Docetaxel Following FE75C as Adjuvant Treatment of Women With Axillary Lymph Node Positive Breast Cancer Over-expressing HER2

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • 3-year disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Recurrence rate [ Time Frame: Relapses by the time of 3-years follow up ] [ Designated as safety issue: No ]
  • Τoxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
  • Quality of life between the two treatment arms [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

Enrollment: 489
Study Start Date: October 2004
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
FEC -> TXT+H 12m
Drug: Docetaxel
Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
Other Name: Taxotere
Drug: Trastuzumab
Trastuzumab 6 mg/Kg IV over 30 min every two weeks for 4 cycles. Subsequently,trastuzumab 6 mg/Kg IV over 30 min for 12 months
Other Name: Herceptin
Drug: Epirubicin
Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Other Name: Farmorubicin
Drug: Cyclophosphamide
Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
Other Name: Endoxan
Drug: 5-fluoruracil
5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
Other Name: 5-FU
Drug: Granulocyte-colony stimulating growth factor
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other Names:
  • Granocyte
  • Neulasta
Experimental: 2
FEC -> TXT+H 6m
Drug: Docetaxel
Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
Other Name: Taxotere
Drug: Epirubicin
Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Other Name: Farmorubicin
Drug: Cyclophosphamide
Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
Other Name: Endoxan
Drug: 5-fluoruracil
5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
Other Name: 5-FU
Drug: Granulocyte-colony stimulating growth factor
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other Names:
  • Granocyte
  • Neulasta
Drug: Trastuzumab
Trastuzumab 6mg/Kg IV over 30 min every 2 weeks for 4 cycles. Subsequently, trastuzumab 6mg/Kg IV over 30 min for 6 months
Other Name: Herceptin

Detailed Description:

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer. Trastuzumab (anti-HER2 monoclonal antibody) in combination with paclitaxel was superior to paclitaxel alone in women with metastatic breast cancer overexpressing HER2

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
  • HER2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or FISH/CISH positivity. A score of 2+ by immunohistochemistry is acceptable only if FISH/CISH positive
  • Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
  • Tumor involvement of at least one axillary lymph node (N0 with HER2/c-neu over expression are also eligible)
  • Absence of any clinical or radiological evidence of local or metastatic disease
  • Premenopausal or postmenopausal women aged 18-75 years old
  • Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
  • Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
  • Adequate cardiac function (LVEF>50%). Normal electrocardiogram and absence of significant heart disease
  • Written informed consent

Exclusion Criteria:

  • Positive pregnancy test.
  • Psychiatric illness or social situation that would preclude study compliance.
  • Other concurrent uncontrolled illness.
  • Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
  • Previous history of other invasive malignancy other than non-melanomatous skin cancer.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615602

Locations
Greece
University Hospital of Crete
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
"Marika Iliadis" Hospital of Athens, 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
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, 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, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00615602     History of Changes
Other Study ID Numbers: CT/04.23
Study First Received: February 1, 2008
Last Updated: June 10, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:
Early breast cancer
Axillary node positive
HER2 overexpression
Adjuvant chemotherapy
Dose dense
Docetaxel
Trastuzumab
FEC

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Docetaxel
Trastuzumab
Epirubicin
Mitogens
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Antimetabolites
Antimetabolites, Antineoplastic
Mitosis Modulators
Tubulin Modulators

ClinicalTrials.gov processed this record on July 31, 2014