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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


Phase 3
18 Years
75 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

3-year disease-free survival

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Dimitris Mavrudis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete

Authority:

Greece: National Organization of Medicines

Study ID:

CT/04.23

NCT ID:

NCT00615602

Start Date:

October 2004

Completion Date:

May 2012

Related Keywords:

  • Breast Cancer
  • Early breast cancer
  • Axillary node positive
  • HER2 overexpression
  • Adjuvant chemotherapy
  • Dose dense
  • Docetaxel
  • Trastuzumab
  • FEC
  • Breast Neoplasms

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