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Neoadjuvant Therapy With Trastuzumab and Docetaxel Followed by Trastuzumab, Caelyx (Liposomal Doxorubicin) and Cyclophosphamide in Operable or Locally Advanced Her-2 Positive Breast Cancer


Phase 2
18 Years
65 Years
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Neoadjuvant Therapy With Trastuzumab and Docetaxel Followed by Trastuzumab, Caelyx (Liposomal Doxorubicin) and Cyclophosphamide in Operable or Locally Advanced Her-2 Positive Breast Cancer


Chemotherapy in association with trastuzumab, a monoclonal antibody, given before surgery,
has been shown to reduce tumor size and permit better resection of HER-2 positive breast
cancers. This study will evaluate the activity of a neoadjuvant treatment with docetaxel
and trastuzumab given every 3 weeks for 4 cycles, followed by the combination of caelyx,
cyclophosphamide and trastuzumab every 3 weeks for 4 cycles. Patients will undergo breast
cancer surgery 2-5 weeks after the completion of neoadjuvant therapy. Adjuvant therapy
after surgery will be given according to existing guidelines, and will include an
additional 10 cycles of trastuzumab.


Inclusion Criteria:



- Histological diagnosis of breast cancer

- Stage II-IIIB (T0-1-2-3-4-N+-M0 or T2-3-4-N0-M0; according to TNM AJCC
classification, 2002)

- Hyperexpression of HER-2/neu (HercepTest 3+ or positive FISH test)

- Age> 18 e < 65 years

- Left ventricular ejection fraction (LVEF) > or = 55%

- ECOG Performance Status 0-2

- Neutrophils > or = 2000/mm³, platelets > or = 100.000/mm³ , hemoglobin > or = 10
g/dl), GOT, GPT and bilirubin < 1.25 x the upper normal limit, creatinine < 1.25 x
the upper normal limit.

- Life expectancy > 3 months

- Signed informed consent.

Exclusion Criteria:

- Any prior treatment for breast cancer

- Metastatic disease (M1)

- Performance status (ECOG) > or = 3

- Current malignancy or history of prior malignancy within past 10 years (with the
exception of adequately treated non-melanoma skin cancer and carcinoma in situ of the
uterine cervix)

- Neutrophils < 2.000/mm³ , platelets < 100.000/mm³ , hemoglobin < 10 g/dl.

- Creatinine > 1.25 x the upper normal limit

- GOT and/or GPT and/or bilirubin >1.25 x the upper normal limit.

- Concomitant conditions that, in the investigator's opinion, contraindicate the use of
the drugs in the protocol.

- Congestive heart failure or history of congestive heart failure, unstable angina
pectoris, myocardial infarction, clinically significant valvulopathy or uncontrolled
arrhythmias

- Active infection

- Incapacity or refusal to provide informed consent.

- Inability to comply with follow up

- Pregnant or nursing females.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

complete pathologic response rate

Principal Investigator

Andrea De Matteis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

NCI Naples, Division of Medical Oncology C

Authority:

Italy: Ethics Committee

Study ID:

CETRA

NCT ID:

NCT00434031

Start Date:

September 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • locally advanced
  • stage II
  • stage IIIa
  • stage IIIb
  • HER-2 positive
  • primary
  • Breast Neoplasms

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