This trial is active, not recruiting.

Condition her-2 positive breast cancer
Treatment trastuzumab
Phase phase 2
Target HER2
Sponsor Lucia Del Mastro,MD
Start date March 2011
End date December 2015
Trial size 43 participants
Trial identifier NCT01340430, 2010-021600-24, NEOHER-021


The main purpose of this study is to confirm the high pathologic complete response rate after neoadjuvant chemotherapy with FEC followed by weekly paclitaxel and concurrent trastuzumab in Human Epidermal growth factor receptor2 (HER2) positive non operable breast cancer

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
fluorouracil 600 mg/m2; epirubicin 90 mg/m2; cyclophosphamide 600 mg/m2 for 4 cycles followed by paclitaxel 80 mg/m2/week in combination with trastuzumab for 12 weeks
trastuzumab herceptin
neoadjuvant FEC (fluorouracil, epirubicin, cyclophosphamide) followed by weekly paclitaxel and concomitant trastuzumab

Primary Outcomes

pathologic complete response
time frame: at definitive surgery within 4 weeks after the last dose of paclitaxel and concurrent trastuzumab

Secondary Outcomes

safety and tolerability
time frame: one year
time frame: one year
disease free survival
time frame: one year
overall survival
time frame: one year
rate of conversion from radical to conservative surgery
time frame: definitive surgery
potential biomarkers of trastuzumab resistance
time frame: one year

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria 1. Performance StatusEstearn Cooperative Oncology Group (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 Nuclear Magnetic Resonance (NMR) 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 immunohistochemistry (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. aspartate aminotransferase (AST) and alanine aminotransferase (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 left ventricular ejection fraction (LVEF) ≥ 50% measured by echocardiography or multigate acquisition scan (MUGA); 15. For women of childbearing potential negative serum pregnancy test 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 informed consent, 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.

Additional Information

Official title Neoadjuvant Therapy With FEC Followed by Weekly Paclitaxel and Concurrent Trastuzumab in Her2 Positive Non Operable Breast Cancer. Phase II Study.
Principal investigator Lucia Del Mastro, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.