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Neoadjuvant Therapy With FEC Followed by Weekly Paclitaxel and Concurrent Trastuzumab in Her2 Positive Non Operable Breast Cancer. Phase II Study.

Phase 2
18 Years
Open (Enrolling)
HER-2 Positive Breast Cancer

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Trial Information

Neoadjuvant Therapy With FEC Followed by Weekly Paclitaxel and Concurrent Trastuzumab in Her2 Positive Non Operable Breast Cancer. Phase II Study.

Inclusion Criteria

Inclusion Criteria

1. Performance Status ECOG 0-1

2. Histologically confirmed invasive breast cancer,

3. Primary tumour greater ≥ 2 cm diameter, measured by clinical examination
and mammography or echography or RMN candidate to neoadjuvant chemotherapy ,

4. Any N,

5. No evidence of metastasis (M0);

6. Over expression and/or amplification of HER2 in the invasive component of the
primary tumour according to one of the following definitions:

7. 3+ over expression by IHC (> 30% of invasive tumour cells),

8. 2+ or 3+ (in 30% o less neoplastic cells) overexpression by IHC and in situ
hybridization (FISH/CISH) test demonstrating Her2 gene amplication ,

9. Her 2 gene amplication by FISH/CISH (ratio > 2.2);

10. Known hormone receptor status

11. Hematopoietic status:

1. absolute neutrophil count ≥ 1.5 x 109/L,

2. platelet count ≥ 100 x 109/L,

12. Hepatic status:

1. serum total bilirubin ≤ 1.5 x ULN. In the case of known Gilbert's syndrome a
higher serum total bilirubin (< 2 x ULN) is allowed,

2. AST and ALT ≤ 2.5 times ULN,

3. alkaline phosphatase ≤ 2.5 times ULN;

13. Renal status:

a. Creatinine ≤ 2.0 mg/dL;

14. Cardiovascular:

a. baseline LVEF ≥ 50% measured by echocardiography or MUGA scan;

15. For women of childbearing potential negative serum pregnancy test12) r. 16.
Written informed consent.

Exclusion Criteria:

1. Male gender

2. Pregnant or lactating women

3. Received any prior treatment for primary invasive breast cancer

4. Known history of uncontrolled or symptomatic angina, clinically significant
arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled
hypertension (> 180/110), unstable diabetes mellitus, dyspnoea at rest or chronic
therapy with oxygen;

5. Active or uncontrolled infection,

6. Dementia altered mental status or any psychiatric condition that would prevent the
under standing or rendering of ICF,

7. Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy,
immunotherapy, biologic therapy other than the trial therapies),

8. Previous or concomitant malignancy within the past 3 years EXCEPT adequately treated
basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix.

9. Concurrent disease or condition that would have make the subject inappropriate for
study participation or any serious medical disorder that would interfere with the
subject's safety.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

pathologic complete response

Outcome Time Frame:

at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab

Safety Issue:


Principal Investigator

Lucia Del Mastro, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute For Cancer Reasearch


Italy: Ethics Committee

Study ID:




Start Date:

March 2011

Completion Date:

Related Keywords:

  • HER-2 Positive Breast Cancer
  • her2 positive breast cancer
  • her2 positive non operable breast cancer
  • her2 positive locally advanced breast cancer
  • neoadjuvant trastuzumab
  • pathologic complete response
  • Breast Neoplasms