Neoadjuvant 5-fluorouracil, Epirubicin and Cyclophosphamide (FEC) Followed by Weekly Paclitaxel and Trastuzumab in Her2 Positive Breast Cancer

NCT01340430 | Completed Phase 2

• 2 other identifiers: NEOHER-0212010-021600-24
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 6

Brief Summary

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

Conditions

HER-2 Positive Breast Cancer

Keywords

her2 positive breast cancer; her2 positive non operable breast cancer; her2 positive locally advanced breast cancer; neoadjuvant trastuzumab; pathologic complete response

Outcome Measures

Primary Outcomes (1)

• pathologic complete response

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

Secondary Outcomes (6)

• safety and tolerability

  one year

• cardiotoxicity

  one year

• disease free survival

  one year

• overall survival

  one year

• rate of conversion from radical to conservative surgery

  definitive surgery

Study Arms (1)

FEC-paclitaxel-trastuzumab

EXPERIMENTAL

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

Drug: Trastuzumab

Interventions

Trastuzumab DRUG

neoadjuvant FEC (fluorouracil, epirubicin, cyclophosphamide) followed by weekly paclitaxel and concomitant trastuzumab

Also known as: herceptin

FEC-paclitaxel-trastuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Performance StatusEstearn Cooperative Oncology Group (ECOG) 0-1
• Histologically confirmed invasive breast cancer,
• Primary tumour greater ≥ 2 cm diameter, measured by clinical examination and mammography or echography or Nuclear Magnetic Resonance (NMR) candidate to neoadjuvant chemotherapy ,
• Any N,
• No evidence of metastasis (M0);
• Over expression and/or amplification of HER2 in the invasive component of the primary tumour according to one of the following definitions:
• + over expression by immunohistochemistry (IHC) (\> 30% of invasive tumour cells),
• + or 3+ (in 30% o less neoplastic cells) overexpression by IHC and in situ hybridization (FISH/CISH) test demonstrating Her2 gene amplication ,
• Her 2 gene amplication by FISH/CISH (ratio \> 2.2);
• Known hormone receptor status
• Hematopoietic status:
• absolute neutrophil count ≥ 1.5 x 109/L,
• platelet count ≥ 100 x 109/L,
• Hepatic status:
• 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,

You may not qualify if:

• Male gender
• Pregnant or lactating women
• Received any prior treatment for primary invasive breast cancer
• 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;
• Active or uncontrolled infection,
• Dementia altered mental status or any psychiatric condition that would prevent the under standing or rendering of informed consent,
• Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies),
• 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.
• 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.

Sponsors & Collaborators

• Lucia Del Mastro,MD: lead

Study Sites (6)

Istituto Nazionale per La Ricerca sul Cancro (IST)

Genoa, Ge, 16132, Italy

Location

Ospedale S. Maria della Misericordia - Oncologia Medica

Perugia, PG, 06156, Italy

Location

Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo

Candiolo, TO, 10060, Italy

Location

Ospedale Ostetrico Ginecologico S. Anna Di Torino - Oncologia Medica

Torino, To, 10100, Italy

Location

Ospedale Mauriziano Umberto I - Ginecologia Oncologica

Torino, TO, 10128, Italy

Location

Ospedale Sacro Cuore - Don Calabria - Oncologia Medica

Negrar, VR, 37024, Italy

Location

MeSH Terms

Conditions

Pathologic Complete Response

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lucia Del Mastro, MD

  National Institute For Cancer Reasearch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: md

Study Record Dates

• First Submitted: April 6, 2011
• First Posted: April 22, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2022
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

IT (6)